Biochemically Recurrent Prostate CarcinomaPhase 3NCT04423211
Treating Prostate Cancer That Has Come Back After Surgery With Apalutamide and Targeted Radiation Based on PET Imaging
A Phase 3 study testing 3-Dimensional Conformal Radiation Therapy, Apalutamide and Computed Tomography in people with Biochemically Recurrent Prostate Carcinoma and Metastatic Prostate Carcinoma, run by ECOG-ACRIN Cancer Research Group at 341 sites in United States.
Trial summary
This phase III trial tests two questions by two separate comparisons of therapies. The first question is whether enhanced therapy (apalutamide in combination with abiraterone + prednisone) added to standard of care (prostate radiation therapy and short term androgen deprivation) is more effective compared to standard… Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Biochemically Recurrent Prostate Carcinoma, Metastatic Prostate Carcinoma, Prostate Adenocarcinoma
- What is being tested?
- 3-Dimensional Conformal Radiation Therapy, Apalutamide and Computed Tomography
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 804 participants
- Where
- 341 sitesUnited States
- Study dates
- 8 Oct 2020to 31 Dec 2032
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- STEP 0: REGISTRATION ELIGIBILITY CRITERIA
- Patient must be male and >= 18 years of age.
- Patient must have had a radical prostatectomy (RP) as definitive therapy for histopathologically-proven prostatic adenocarcinoma
- Patient must have biochemical recurrence (BCR) after RP, defined as follows:
- If time to BCR, defined as time to first detectable PSA ( > lower limit of normal for assay used) after RP, is < 12 months, a minimum PSA level of >= 0.2 ng/mL and a confirmatory reading of >= 0.2 ng/mL is required, per the American Urological Association (AUA) definition (Note: patients with a persistent PSA reading of at least 0.2 ng/mL are eligible)
- If time to BCR, defined as time to first detectable PSA (> lower limit of normal for assay used) after RP, is >= 12 months, a minimum absolute PSA of 0.5 ng/mL is required
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- If the patient has a detectable PSA (> lower limit of normal for assay used) at any time after RP AND has an eligible baseline SOC PET (PET1) with at least one positive lesion in any location, then there is no minimum PSA requirement
- Patients must have no definite evidence for extrapelvic metastatic disease by conventional imaging modalities (CIM) (CT abdomen/pelvis or MRI abdomen/pelvis AND bone scintigraphy, or equivalent), within 26 weeks prior to Step 0 registration. If a patient only has a study-eligible PET/CT or PET/MR (i.e., PET done without prior CIM): if the PET is negative for extrapelvic lesions, then baseline CIM is NOT required. If the PET positive for extrapelvic lesions, then patient should have a baseline CT/MRI for soft tissue lesions and/or a bone scan for osseous lesions
- Study eligible = PET using FDA-approved radiotracer and performed within 16 weeks prior to study registration
- Extra-pelvic metastases is defined as any osseous metastases and/or any extrapelvic soft tissue, lymph nodes and organ metastases; extra-pelvic is defined as superior to common iliac bifurcation, outside of standard prostate bed + whole pelvis nodal RT fields. Baseline PET/CT or PET/MR scan (PET1) is eligible for this study if the SOC PET scan is completed with an FDA approved radiotracer for prostate cancer after Step 0 registration and prior to Step 1 randomization OR up to 16 weeks prior to Step 0 registration
- Patient must be a candidate for SOC post-prostatectomy radiation therapy (RT) to the prostate bed and pelvic nodes with androgen deprivation therapy (ADT)
- Patient must have the ability to understand and the willingness to sign a written informed consent document. Patients with impaired decision-making capacity (IDMC) who have a legally authorized representative (LAR) or caregiver and/or family member available will also be considered eligible
- Patient must have an Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- Patient must not have started ADT for biochemical recurrence prior to baseline PET (PET1) imaging. A short course of low-dose anti-androgen such as bicalutamide, given after baseline study PET/CT but prior to study registration, is permitted as a brief temporizing measure in advance of starting protocol-approved SOC ADT.
- Patient must not be enrolled in another therapeutic clinical trial
- Patient must be able to lie flat and still for approximately 20-30 minutes or otherwise tolerate a PET scan and radiation treatment planning and delivery
- Patients undergoing a PET/MR must meet local institutional safety guidelines for MRI
- Patient must not have history of seizures or known condition that may cause predisposal to seizures (e.g., stroke or head trauma resulting in loss of consciousness) within 1 year prior to registration
- Patient must not have history of inflammatory bowel disease or any gastrointestinal disorder affecting absorption that is expected to increase risk of complication from radiotherapy
- Hemoglobin (Hgb) >= 9.0 g/dL (independent of transfusion and/or growth factors within 3 months prior to Step 0 registration) (obtained within 8 weeks prior to Step 0 registration)
- Leukocytes >= 3,000/mcL (obtained within 8 weeks prior to Step 0 registration)
- Absolute neutrophil count >= 1,500/mcL (obtained within 8 weeks prior to Step 0 registration)
- Platelets >= 100,000/mcL (obtained within 8 weeks prior to Step 0 registration)
- Total bilirubin < 1.5 x institutional upper limit of normal (ULN) (patients with Gilbert's syndrome, if total bilirubin is > 1.5 x ULN, must have a direct bilirubin of < 1.5 x ULN to be eligible) (obtained within 8 weeks prior to Step 0 registration)
- Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 2.5 x institutional ULN (obtained within 8 weeks prior to Step 0 registration)
- Creatine < 1.5 x instituional ULN (or measured creatinine clearance > 30 mL/min)
- Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial
- Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class I or II (by patient symptoms) or A or B (by objective assessment)
- Patient must not have completed a course of prior pelvic radiation therapy for any reason
- Patient must agree not to father children while on study
- Patient must be English or Spanish speaking to be eligible for the QOL component of the study
- NOTE: Sites cannot translate the associated QOL forms
- STEP 1: RANDOMIZATION ELIGIBILITY CRITERIA
- Patient must have completed a baseline SOC PET/CT or PET/MR (PET1 scan) using FDA approved radiotracer with results of extra-pelvic metastases involvement known (positive or negative). The PET1 must have been completed after Step 0 registration and prior to Step 1 randomization OR up to 12 weeks prior to Step 0 registration
- For patients with negative extra-pelvic metastases, PET-imaging status of intra-pelvic nodes must be known (positive or negative)
- For patients with positive extra-pelvic metastases (defined as any PET positive lesions outside of standard salvage RT fields [prostate bed +/- typical whole pelvis]), the number of extra-pelvic lesions must be known (1 - 5 or > 5 extra-pelvic lesions)
Who cannot join
None listed.
Trial locations and contacts
341 sites in 1 country. Contact the study team or a site near you to ask about taking part.
300 sites in 1 country
United States300 sites, 243 recruiting
- Recruiting
Providence Regional Cancer System-Aberdeen
Aberdeen, Washington, 98520
Site Public Contact, 360-412-8958, deidre.dillon@providence.org
Alison K. Conlin
- Recruiting
Alton Memorial Hospital
Alton, Illinois, 62002
Site Public Contact, 618-463-7323
Jeff M. Michalski
- Recruiting
OSF Saint Anthony's Health Center
Alton, Illinois, 62002
Site Public Contact, 618-463-5623
Jay W. Carlson
- Recruiting
UPMC Altoona
Altoona, Pennsylvania, 16601
Site Public Contact, ecog.rss@jimmy.harvard.edu
Adam Olson
- Recruiting
Anchorage Associates in Radiation Medicine
Anchorage, Alaska, 98508
Site Public Contact, 907-212-6871, AKPAMC.OncologyResearchSupport@providence.org
Alison K. Conlin
- Recruiting
Alaska Breast Care and Surgery LLC
Anchorage, Alaska, 99508
Site Public Contact, 907-212-6871, AKPAMC.OncologyResearchSupport@providence.org
Alison K. Conlin
- Recruiting
Alaska Oncology and Hematology LLC
Anchorage, Alaska, 99508
Site Public Contact, 907-212-6871, AKPAMC.OncologyResearchSupport@providence.org
Alison K. Conlin
- Recruiting
Alaska Women's Cancer Care
Anchorage, Alaska, 99508
Site Public Contact, 907-212-6871, AKPAMC.OncologyResearchSupport@providence.org
Alison K. Conlin
- Suspended
Anchorage Oncology Centre
Anchorage, Alaska, 99508
- Recruiting
Katmai Oncology Group
Anchorage, Alaska, 99508
Site Public Contact, 907-212-6871, AKPAMC.OncologyResearchSupport@providence.org
Alison K. Conlin
- Recruiting
Providence Alaska Medical Center
Anchorage, Alaska, 99508
Site Public Contact, 907-212-6871, AKPAMC.OncologyResearchSupport@providence.org
Alison K. Conlin
- Recruiting
Aspirus Cancer Care-Antigo-Volm Cancer Center
Antigo, Wisconsin, 54409
Site Public Contact, 715-623-9869, Juli.Alford@aspirus.org
Andrew J. Huang
- Recruiting
Mission Hope Medical Oncology - Arroyo Grande
Arroyo Grande, California, 93420
Site Public Contact, 720-874-1881, ResearchInstituteInquiries@CommonSpirit.org
Shahzad Siddique
- Active, not recruiting
Rocky Mountain Cancer Centers-Aurora
Aurora, Colorado, 80012
- Recruiting
Rush-Copley Medical Center
Aurora, Illinois, 60504
Site Public Contact, 630-978-6212, RCMC_Cancer_Research@rush.edu
Sinisa Stanic
- Active, not recruiting
University of Maryland/Greenebaum Cancer Center
Baltimore, Maryland, 21201
- Recruiting
Johns Hopkins University/Sidney Kimmel Cancer Center
Baltimore, Maryland, 21287
Site Public Contact, 410-955-8804, jhcccro@jhmi.edu
Curtiland Deville
- Active, not recruiting
MaineHealth Coastal Cancer Treatment Center
Bath, Maine, 04530
- Recruiting
LSU Health Baton Rouge-North Clinic
Baton Rouge, Louisiana, 70805
Site Public Contact, 225-765-7659, research@ololrmc.com
Marshall P. Stagg
- Recruiting
Our Lady of the Lake Physician Group
Baton Rouge, Louisiana, 70808
Site Public Contact, 225-765-7659, research@ololrmc.com
Marshall P. Stagg
- Recruiting
Northwell Health Imbert Cancer Center
Bay Shore, New York, 11706
Site Public Contact, 516-734-8896
Clary Evans
- Recruiting
UPMC-Heritage Valley Health System Beaver
Beaver, Pennsylvania, 15009
Site Public Contact, 412-389-5208, haneydl@upmc.edu
Adam Olson
- Recruiting
PeaceHealth Saint Joseph Medical Center
Bellingham, Washington, 98225
Site Public Contact, 360-788-8223, achapman1@peacehealth.org
Alison K. Conlin
- Recruiting
Saint Charles Health System
Bend, Oregon, 97701
Site Public Contact, 541-706-2909, nosall@stcharleshealthcare.org
Alison K. Conlin
- Recruiting
Suburban Hospital
Bethesda, Maryland, 20814
Site Public Contact, 301-896-2719, bsquill1@jhmi.edu
Curtiland Deville
- Active, not recruiting
MaineHealth Maine Medical Center - Biddeford
Biddeford, Maine, 04005
- Recruiting
Billings Clinic Cancer Center
Billings, Montana, 59101
Site Public Contact, 800-996-2663, research@billingsclinic.org
John M. Schallenkamp
- Recruiting
Illinois CancerCare-Bloomington
Bloomington, Illinois, 61704
Site Public Contact, 309-243-3605, andersonj@illinoiscancercare.com
Bryan A. Faller
- Suspended
Saint Alphonsus Cancer Care Center-Boise
Boise, Idaho, 83706
- Recruiting
Saint Luke's Cancer Institute - Boise
Boise, Idaho, 83712
Site Public Contact, 208-381-2774, eslinget@slhs.org
Alison K. Conlin
- Recruiting
Central Care Cancer Center - Bolivar
Bolivar, Missouri, 65613
Site Public Contact, 913-948-5588, aroland@kccop.org
Jay W. Carlson
- Active, not recruiting
Rocky Mountain Cancer Centers-Boulder
Boulder, Colorado, 80304
- Recruiting
Bozeman Health Deaconess Hospital
Bozeman, Montana, 59715
Site Public Contact, 406-969-6060, mccinfo@mtcancer.org
John M. Schallenkamp
- Active, not recruiting
Crozer-Keystone Regional Cancer Center at Broomall
Broomall, Pennsylvania, 19008
- Recruiting
Providence Saint Joseph Medical Center/Disney Family Cancer Center
Burbank, California, 91505
Site Public Contact, 818-847-4793, Najee.Boucher@providence.org
Alison K. Conlin
- Recruiting
Minnesota Oncology - Burnsville
Burnsville, Minnesota, 55337
Site Public Contact, 952-993-1517, mmcorc@healthpartners.com
David M. King
- Suspended
Saint Alphonsus Cancer Care Center-Caldwell
Caldwell, Idaho, 83605
- Recruiting
Cooper Hospital University Medical Center
Camden, New Jersey, 08103
Site Public Contact, 856-325-6757
Gary Eastwick
- Recruiting
Illinois CancerCare-Canton
Canton, Illinois, 61520
Site Public Contact, 309-243-3605, andersonj@illinoiscancercare.com
Bryan A. Faller
- Recruiting
Mercy Cancer Center - Cape Girardeau
Cape Girardeau, Missouri, 63703
Site Public Contact, 888-446-3729
Jay W. Carlson
- Recruiting
Saint Francis Medical Center
Cape Girardeau, Missouri, 63703
Site Public Contact, 573-334-2230, sfmc@sfmc.net
Bryan A. Faller
- Recruiting
Memorial Hospital of Carbondale
Carbondale, Illinois, 62902
Site Public Contact, 618-457-5200, clinical.research@sih.net
Bryan A. Faller
- Recruiting
Carlisle Regional Cancer Center
Carlisle, Pennsylvania, 17015
Site Public Contact, ecog.rss@jimmy.harvard.edu
Adam Olson
- Recruiting
Mercy Cancer Center - Carmichael
Carmichael, California, 95608
Site Public Contact, 720-874-1881, ResearchInstituteInquiries@CommonSpirit.org
Shahzad Siddique
- Recruiting
Mercy San Juan Medical Center
Carmichael, California, 95608
Site Public Contact, 720-874-1881, ResearchInstituteInquiries@commonspirit.org
Shahzad Siddique
- Recruiting
SIH Cancer Institute
Carterville, Illinois, 62918
Site Public Contact, 618-985-3333, clinical.research@sih.net
Bryan A. Faller
- Recruiting
Illinois CancerCare-Carthage
Carthage, Illinois, 62321
Site Public Contact, 309-243-3605, andersonj@illinoiscancercare.com
Bryan A. Faller
- Recruiting
Mercy Hospital
Cedar Rapids, Iowa, 52403
Site Public Contact, 319-365-4673
Deborah W. Wilbur
- Recruiting
Oncology Associates at Mercy Medical Center
Cedar Rapids, Iowa, 52403
Site Public Contact, 319-363-2690
Deborah W. Wilbur
- Recruiting
Centralia Oncology Clinic
Centralia, Illinois, 62801
Site Public Contact, 217-876-4762, morganthaler.jodi@mhsil.com
Bryan A. Faller
- Suspended
Saint Mary's Hospital
Centralia, Illinois, 62801
- Recruiting
Providence Regional Cancer System-Centralia
Centralia, Washington, 98531
Site Public Contact, 360-412-8958, deidre.dillon@providence.org
Alison K. Conlin
- Recruiting
Medical University of South Carolina
Charleston, South Carolina, 29425
Site Public Contact, 843-792-9321, hcc-clinical-trials@musc.edu
Harriet B. Eldredge-Hindy
- Recruiting
University of Virginia Cancer Center
Charlottesville, Virginia, 22908
Site Public Contact, 434-243-6303, uvacancertrials@hscmail.mcc.virginia.edu
Michael E. Devitt
- Recruiting
Minnesota Oncology Hematology PA-Chaska
Chaska, Minnesota, 55318
Site Public Contact, 952-993-1517, mmcorc@healthpartners.com
David M. King
- Recruiting
Memorial Hospital of Laramie County
Cheyenne, Wyoming, 82001
Site Public Contact, ecog.rss@jimmy.harvard.edu
John M. Schallenkamp
- Recruiting
Northwestern University
Chicago, Illinois, 60611
Site Public Contact, 312-695-1301, cancer@northwestern.edu
Sean Sachdev
- Recruiting
Rush MD Anderson Cancer Center
Chicago, Illinois, 60612
Site Public Contact, 312-226-2371, Cancer_Studies@rush.edu
Dian Wang
- Recruiting
University of Illinois
Chicago, Illinois, 60612
Site Public Contact, 312-355-3046
Daniel Moreira
- Active, not recruiting
University of Cincinnati Cancer Center-UC Medical Center
Cincinnati, Ohio, 45219
- Recruiting
Good Samaritan Hospital - Cincinnati
Cincinnati, Ohio, 45220
Site Public Contact, 720-874-1881, ResearchInstituteInquiries@CommonSpirit.org
Shahzad Siddique
- Recruiting
Bethesda North Hospital
Cincinnati, Ohio, 45242
Site Public Contact, 720-874-1881, ResearchInstituteInquiries@CommonSpirit.org
Shahzad Siddique
- Recruiting
Siteman Cancer Center at Saint Peters Hospital
City of Saint Peters, Missouri, 63376
Site Public Contact, 800-600-3606, info@siteman.wustl.edu
Jeff M. Michalski
- Recruiting
Clackamas Radiation Oncology Center
Clackamas, Oregon, 97015
Site Public Contact, 503-215-2614, CanRsrchStudies@providence.org
Alison K. Conlin
- Suspended
Providence Cancer Institute Clackamas Clinic
Clackamas, Oregon, 97015
- Recruiting
Kootenai Health - Coeur d'Alene
Coeur d'Alene, Idaho, 83814
Site Public Contact, 406-969-6060, mccinfo@mtcancer.org
John M. Schallenkamp
- Recruiting
Penrose-Saint Francis Healthcare
Colorado Springs, Colorado, 80907
Site Public Contact, 720-874-1881, ResearchInstituteInquiries@CommonSpirit.org
Shahzad Siddique
- Recruiting
Rocky Mountain Cancer Centers-Penrose
Colorado Springs, Colorado, 80907
Site Public Contact, 720-874-1881, ResearchInstituteInquiries@CommonSpirit.org
Shahzad Siddique
- Recruiting
Saint Francis Cancer Center
Colorado Springs, Colorado, 80923
Site Public Contact, 720-874-1881, ResearchInstituteInquiries@CommonSpirit.org
Shahzad Siddique
- Recruiting
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210
Site Public Contact, 800-293-5066, Jamesline@osumc.edu
Shang-Jui Wang
- Recruiting
Mercy Hospital
Coon Rapids, Minnesota, 55433
Site Public Contact, 952-993-1517, mmcorc@healthpartners.com
David M. King
- Recruiting
Minnesota Oncology - Coon Rapids
Coon Rapids, Minnesota, 55433
Site Public Contact, 952-993-1517, mmcorc@healthpartners.com
David M. King
- Recruiting
Bay Area Hospital
Coos Bay, Oregon, 97420
Site Public Contact, 541-269-8392, cherie.cox@bayareahospital.org
Alison K. Conlin
- Recruiting
City of Hope Corona
Corona, California, 92882
Site Public Contact, 626-256-4673, becomingapatient@coh.org
Scott M. Glaser
- Recruiting
Siteman Cancer Center at West County Hospital
Creve Coeur, Missouri, 63141
Site Public Contact, 800-600-3606, info@siteman.wustl.edu
Jeff M. Michalski
- Recruiting
Parkland Memorial Hospital
Dallas, Texas, 75235
Site Public Contact, 214-590-5582, canceranswerline@UTSouthwestern.edu
Kevin D. Courtney
- Recruiting
UT Southwestern Simmons Cancer Center - RedBird
Dallas, Texas, 75237
Site Public Contact, 214-648-7097, canceranswerline@utsouthwestern.edu
Kevin D. Courtney
- Recruiting
UT Southwestern/Simmons Cancer Center-Dallas
Dallas, Texas, 75390
Site Public Contact, 214-648-7097, canceranswerline@UTSouthwestern.edu
Kevin D. Courtney
- Recruiting
Carle at The Riverfront
Danville, Illinois, 61832
Site Public Contact, 800-446-5532, Research@Carle.com
Sinisa Stanic
- Recruiting
Cancer Care Specialists of Illinois - Decatur
Decatur, Illinois, 62526
Site Public Contact, 217-876-4762, morganthaler.jodi@mhsil.com
Bryan A. Faller
- Recruiting
Decatur Memorial Hospital
Decatur, Illinois, 62526
Site Public Contact, 217-876-4762, morganthaler.jodi@mhsil.com
Bryan A. Faller
- Recruiting
Northwestern Medicine Cancer Center Kishwaukee
DeKalb, Illinois, 60115
Site Public Contact, 630-352-5360, Donald.Smith3@nm.org
William F. Hartsell
- Suspended
AdventHealth Porter
Denver, Colorado, 80210
- Active, not recruiting
Presbyterian - Saint Lukes Medical Center - Health One
Denver, Colorado, 80218
- Recruiting
Dillon Health Center/Shaw Cancer Center
Dillon, Colorado, 80435
Site Public Contact, 970-470-7170
Erin Schwab
- Suspended
Illinois CancerCare-Dixon
Dixon, Illinois, 61021
- Active, not recruiting
Delaware County Memorial Hospital
Drexel Hill, Pennsylvania, 19026
- Recruiting
City of Hope Comprehensive Cancer Center
Duarte, California, 91010
Scott M. Glaser, 626-218-2247, sglaser@coh.org
Scott M. Glaser
- Active, not recruiting
Fox Chase Cancer Center - East Norriton Hospital Outpatient Center
East Norriton, Pennsylvania, 19401
- Recruiting
Marshfield Medical Center-EC Cancer Center
Eau Claire, Wisconsin, 54701
Site Public Contact, 800-782-8581, oncology.clinical.trials@marshfieldresearch.org
Isaac K. Yeboah
- Recruiting
Fairview Southdale Hospital
Edina, Minnesota, 55435
Site Public Contact, 952-993-1517, mmcorc@healthpartners.com
David M. King
- Recruiting
Minnesota Oncology - Edina
Edina, Minnesota, 55435
Site Public Contact, 952-993-1517, mmcorc@healthpartners.com
David M. King
- Recruiting
Swedish Cancer Institute-Edmonds
Edmonds, Washington, 98026
Site Public Contact, 206-215-2343, PCRC-NCORP@Swedish.org
Alison K. Conlin
- Recruiting
Shaw Cancer Center
Edwards, Colorado, 81632
Site Public Contact, 970-569-7429
Erin Schwab
- Recruiting
Carle Physician Group-Effingham
Effingham, Illinois, 62401
Site Public Contact, 800-446-5532, Research@carle.com
Sinisa Stanic
- Recruiting
Crossroads Cancer Center
Effingham, Illinois, 62401
Site Public Contact, 217-876-4762, morganthaler.jodi@mhsil.com
Bryan A. Faller
- Recruiting
Mercy Cancer Center - Elk Grove
Elk Grove, California, 95758
Site Public Contact, 720-874-1881, ResearchInstituteInquiries@CommonSpirit.org
Shahzad Siddique
- Recruiting
UC San Diego Health System - Encinitas
Encinitas, California, 92024
Site Public Contact, 760-536-7700
James M. Randall
- Active, not recruiting
The Melanoma and Skin Cancer Institute
Englewood, Colorado, 80113
- Recruiting
UPMC Hillman Cancer Center Erie
Erie, Pennsylvania, 16505
Site Public Contact, 412-864-7716, ClinicalResearchServices@upmc.edu
Adam Olson
- Recruiting
Illinois CancerCare-Eureka
Eureka, Illinois, 61530
Site Public Contact, 309-243-3605, andersonj@illinoiscancercare.com
Bryan A. Faller
- Recruiting
Providence Regional Cancer Partnership
Everett, Washington, 98201
Site Public Contact, 425-261-3529, marilyn.birchman@providence.org
Alison K. Conlin
- Recruiting
Fairbanks Memorial Hospital
Fairbanks, Alaska, 99701
Site Public Contact, 907-458-3043, Veronica.Stevenson@foundationhealth.org
John M. Schallenkamp
- Recruiting
Parkland Health Center - Farmington
Farmington, Missouri, 63640
Site Public Contact, 314-996-5569
Bryan A. Faller
- Recruiting
UPMC Cancer Center at UPMC Horizon
Farrell, Pennsylvania, 16121
Site Public Contact, ecog.rss@jimmy.harvard.edu
Adam Olson
- Recruiting
Northwell Health Physicians Partners Radiation Medicine at Queens
Forest Hills, New York, 11375
Site Public Contact, 718-520-6620
Clary Evans
- Recruiting
Mercy Hospital Fort Smith
Fort Smith, Arkansas, 72903
Site Public Contact, 800-378-9373
Jay W. Carlson
- Recruiting
Tarrant County Hospital District/JPS Health Network
Fort Worth, Texas, 76104
Site Public Contact, 817-702-5913, macosta02@jpshealth.org
Marta Dahiya
- Recruiting
UT Southwestern/Simmons Cancer Center-Fort Worth
Fort Worth, Texas, 76104
Site Public Contact, 214-648-7097, canceranswerline@UTSouthwestern.edu
Kevin D. Courtney
- Active, not recruiting
Unity Hospital
Fridley, Minnesota, 55432
- Recruiting
Saint Luke's Cancer Institute - Fruitland
Fruitland, Idaho, 83619
Site Public Contact, 208-381-2774, eslinget@slhs.org
Alison K. Conlin
- Active, not recruiting
Fox Chase Cancer Center Buckingham
Furlong, Pennsylvania, 18925
- Recruiting
Illinois CancerCare-Galesburg
Galesburg, Illinois, 61401
Site Public Contact, 309-243-3605, andersonj@illinoiscancercare.com
Bryan A. Faller
- Suspended
Western Illinois Cancer Treatment Center
Galesburg, Illinois, 61401
- Recruiting
Central Care Cancer Center - Garden City
Garden City, Kansas, 67846
Site Public Contact, 913-948-5588, aroland@kccop.org
Jay W. Carlson
- Recruiting
Northwestern Medicine Cancer Center Delnor
Geneva, Illinois, 60134
Site Public Contact, 630-352-5360, Donald.Smith3@nm.org
William F. Hartsell
- Active, not recruiting
UM Baltimore Washington Medical Center/Tate Cancer Center
Glen Burnie, Maryland, 21061
- Active, not recruiting
Crozer Regional Cancer Center at Brinton Lake
Glen Mills, Pennsylvania, 19342
- Suspended
Central Care Cancer Center - Great Bend
Great Bend, Kansas, 67530
- Recruiting
Benefis Sletten Cancer Institute
Great Falls, Montana, 59405
Site Public Contact, 406-969-6060, mccinfo@mtcancer.org
John M. Schallenkamp
- Recruiting
Great Falls Clinic
Great Falls, Montana, 59405
Site Public Contact, 406-969-6060, mccinfo@mtcancer.org
John M. Schallenkamp
- Recruiting
UPMC Cancer Centers - Arnold Palmer Pavilion
Greensburg, Pennsylvania, 15601
Site Public Contact, 724-838-1900
Adam Olson
- Recruiting
Baptist Cancer Center-Grenada
Grenada, Mississippi, 38901
Site Public Contact, 901-226-1366, BCCclintrials@bmhcc.org
Andrew J. Benefield
- Active, not recruiting
Legacy Mount Hood Medical Center
Gresham, Oregon, 97030
- Active, not recruiting
Hackensack University Medical Center
Hackensack, New Jersey, 07601
- Recruiting
UPMC Pinnacle Cancer Center/Community Osteopathic Campus
Harrisburg, Pennsylvania, 17109
Site Public Contact, 717-724-6765, klitchfield@PINNACLEHEALTH.org
Adam Olson
- Recruiting
Hi-Line Sletten Cancer Center
Havre, Montana, 59501
Site Public Contact, ecog.rss@jimmy.harvard.edu
John M. Schallenkamp
- Recruiting
Penn State Milton S Hershey Medical Center
Hershey, Pennsylvania, 17033-0850
Site Public Contact, 717-531-3779, CTO@hmc.psu.edu
Joseph A. Miccio
- Recruiting
Swedish Cancer Institute-Issaquah
Issaquah, Washington, 98029
Site Public Contact, 206-215-2343, PCRC-NCORP@Swedish.org
Alison K. Conlin
- Active, not recruiting
University of Mississippi Medical Center
Jackson, Mississippi, 39216
- Suspended
MU Health Care Goldschmidt Cancer Center
Jefferson City, Missouri, 65109
- Recruiting
University of Wisconsin Carbone Cancer Center - Johnson Creek
Johnson Creek, Wisconsin, 53038
Site Public Contact, 800-622-8922, clinicaltrials@cancer.wisc.edu
John M. Floberg
- Recruiting
UPMC-Johnstown/John P. Murtha Regional Cancer Center
Johnstown, Pennsylvania, 15901
Site Public Contact, 814-534-4724
Adam Olson
- Recruiting
Freeman Health System
Joplin, Missouri, 64804
Site Public Contact, 417-347-4030, LJCrockett@freemanhealth.com
Jay W. Carlson
- Recruiting
Mercy Hospital Joplin
Joplin, Missouri, 64804
Site Public Contact, 417-556-3074, esmeralda.carrillo@mercy.net
Jay W. Carlson
- Recruiting
Logan Health Medical Center
Kalispell, Montana, 59901
Site Public Contact, 406-969-6060, mccinfo@mtcancer.org
John M. Schallenkamp
- Recruiting
CHI Health Good Samaritan
Kearney, Nebraska, 68847
Site Public Contact, 720-874-1881, ResearchInstituteInquiries@CommonSpirit.org
Shahzad Siddique
- Suspended
ECU Health Oncology Kenansville
Kenansville, North Carolina, 28349
- Recruiting
Kadlec Clinic Hematology and Oncology
Kennewick, Washington, 99336
Site Public Contact, 509-783-4637, research@kadlecmed.org
Alison K. Conlin
- Recruiting
Illinois CancerCare-Kewanee Clinic
Kewanee, Illinois, 61443
Site Public Contact, 309-243-3605, andersonj@illinoiscancercare.com
Bryan A. Faller
- Recruiting
ECU Health Oncology Kinston
Kinston, North Carolina, 28501
Site Public Contact, 252-559-2201, research@ecuhealth.org
Haritha Ackula
- Recruiting
UC San Diego Moores Cancer Center
La Jolla, California, 92093
Site Public Contact, 858-822-5354, cancercto@ucsd.edu
James M. Randall
- Recruiting
Providence Regional Cancer System-Lacey
Lacey, Washington, 98503
Site Public Contact, 360-412-8958, deidre.dillon@providence.org
Alison K. Conlin
- Recruiting
Northwell Health/Center for Advanced Medicine
Lake Success, New York, 11042
Site Public Contact, 516-734-8896
Clary Evans
- Recruiting
CommonSpirit Saint Anthony Hospital Cancer Center
Lakewood, Colorado, 80228
Site Public Contact, 720-874-1881, ResearchInstituteInquiries@CommonSpirit.org
Shahzad Siddique
- Recruiting
City of Hope Antelope Valley
Lancaster, California, 93534
Site Public Contact, 800-826-4673, becomingapatient@coh.org
Scott M. Glaser
- Recruiting
CommonSpirit Saint Joseph Hospital - Lexington
Lexington, Kentucky, 40504
Site Public Contact, 720-874-1881, ResearchInstituteInquiries@CommonSpirit.org
Shahzad Siddique
- Recruiting
Saint Joseph Radiation Oncology Resource Center
Lexington, Kentucky, 40504
Site Public Contact, 720-874-1881, ResearchInstituteInquiries@CommonSpirit.org
Shahzad Siddique
- Recruiting
CommonSpirit Saint Joseph Medical Center - East Lexington
Lexington, Kentucky, 40509
Site Public Contact, 720-874-1881, ResearchInstituteInquiries@CommonSpirit.org
Shahzad Siddique
- Recruiting
Rush MD Anderson Cancer Center at Rush Lisle
Lisle, Illinois, 60532
Site Public Contact, 312-226-2371, Cancer_Studies@rush.edu
Dian Wang
- Active, not recruiting
Rocky Mountain Cancer Centers-Littleton
Littleton, Colorado, 80120
- Suspended
AdventHealth Littleton
Littleton, Colorado, 80122
- Recruiting
Longmont United Hospital
Longmont, Colorado, 80501
Site Public Contact, 720-874-1881, ResearchInstituteInquiries@CommonSpirit.org
Shahzad Siddique
- Recruiting
PeaceHealth Saint John Medical Center
Longview, Washington, 98632
Site Public Contact, 360-514-2016, kmakin-bond@peacehealth.org
Alison K. Conlin
- Active, not recruiting
Los Angeles General Medical Center
Los Angeles, California, 90033
- Active, not recruiting
USC / Norris Comprehensive Cancer Center
Los Angeles, California, 90033
- Recruiting
UCLA / Jonsson Comprehensive Cancer Center
Los Angeles, California, 90095
Site Public Contact, 888-798-0719
Amar Kishan
- Suspended
Jewish Hospital
Louisville, Kentucky, 40202
- Recruiting
Illinois CancerCare-Macomb
Macomb, Illinois, 61455
Site Public Contact, 309-243-3605, andersonj@illinoiscancercare.com
Bryan A. Faller
- Recruiting
William S Middleton VA Medical Center
Madison, Wisconsin, 53705
Site Public Contact, 608-256-1901 ext. 17007
Jessica M. Schuster
- Recruiting
University of Wisconsin Carbone Cancer Center - Eastpark Medical Center
Madison, Wisconsin, 53718
Site Public Contact, 800-622-8922, clinicaltrials@cancer.wisc.edu
John M. Floberg
- Recruiting
University of Wisconsin Carbone Cancer Center - University Hospital
Madison, Wisconsin, 53792
Site Public Contact, 800-622-8922, clinicaltrials@cancer.wisc.edu
John M. Floberg
- Recruiting
Fairview Clinics and Surgery Center Maple Grove
Maple Grove, Minnesota, 55369
Site Public Contact, 952-993-1517, mmcorc@healthpartners.com
David M. King
- Recruiting
Minnesota Oncology - Maple Grove
Maple Grove, Minnesota, 55369
Site Public Contact, 952-993-1572, mmcorc@healthpartners.com
David M. King
- Recruiting
Minnesota Oncology Hematology PA-Maplewood
Maplewood, Minnesota, 55109
Site Public Contact, 952-993-1517, mmcorc@healthpartners.com
David M. King
- Recruiting
Saint John's Hospital - Healtheast
Maplewood, Minnesota, 55109
Site Public Contact, 952-993-1517, mmcorc@healthpartners.com
David M. King
- Recruiting
Marshfield Medical Center-Marshfield
Marshfield, Wisconsin, 54449
Site Public Contact, 800-782-8581, oncology.clinical.trials@marshfieldresearch.org
Isaac K. Yeboah
- Recruiting
Carle Physician Group-Mattoon/Charleston
Mattoon, Illinois, 61938
Site Public Contact, 800-446-5532, Research@carle.com
Sinisa Stanic
- Active, not recruiting
Loyola University Medical Center
Maywood, Illinois, 60153
- Recruiting
UPMC Hillman Cancer Center at Rocco And Nancy Ortenzio Cancer Pavilion
Mechanicsburg, Pennsylvania, 17050
Site Public Contact, 412-389-5208, haneydl@upmc.edu
Adam Olson
- Suspended
Mercy Cancer Center
Merced, California, 95340
- Suspended
Idaho Urologic Institute-Meridian
Meridian, Idaho, 83642
- Recruiting
Saint Luke's Cancer Institute - Meridian
Meridian, Idaho, 83642
Site Public Contact, 208-381-2774, eslinget@slhs.org
Alison K. Conlin
- Recruiting
Abbott-Northwestern Hospital
Minneapolis, Minnesota, 55407
Site Public Contact, 952-993-1517, mmcorc@healthpartners.com
David M. King
- Recruiting
Hennepin County Medical Center
Minneapolis, Minnesota, 55415
Site Public Contact, 952-993-1517, mmcorc@healthpartners.com
David M. King
- Recruiting
Health Partners Inc
Minneapolis, Minnesota, 55454
Site Public Contact, 952-993-1517, mmcorc@healthpartners.com
David M. King
- Recruiting
Marshfield Medical Center - Minocqua
Minocqua, Wisconsin, 54548
Site Public Contact, 800-782-8581, oncology.clinical.trials@marshfieldresearch.org
Isaac K. Yeboah
- Recruiting
Saint Patrick Hospital - Community Hospital
Missoula, Montana, 59802
Site Public Contact, 406-327-3118, amy.hanneman@providence.org
Alison K. Conlin
- Recruiting
Community Medical Center
Missoula, Montana, 59804
Site Public Contact, 406-969-6060, mccinfo@mtcancer.org
John M. Schallenkamp
- Recruiting
UPMC Cancer Center - Monroeville
Monroeville, Pennsylvania, 15146
Site Public Contact, ecog.rss@jimmy.harvard.edu
Adam Olson
- Recruiting
Monticello Cancer Center
Monticello, Minnesota, 55362
Site Public Contact, 952-993-1517, mmcorc@healthpartners.com
David M. King
- Recruiting
UPMC Hillman Cancer Center in Coraopolis
Moon Township, Pennsylvania, 15108
Site Public Contact, 412-389-5208, haneydl@upmc.edu
Adam Olson
- Recruiting
SSM Health Good Samaritan
Mount Vernon, Illinois, 62864
Site Public Contact, 618-899-1894, gayla.hall@ssmhealth.com
Jay W. Carlson
- Recruiting
Skagit Regional Health Cancer Care Center
Mount Vernon, Washington, 98274
Site Public Contact, 360-814-2182, rcccclinicalresearch@skagitvalleyhospital.org
Alison K. Conlin
- Suspended
Saint Alphonsus Cancer Care Center-Nampa
Nampa, Idaho, 83687
- Recruiting
Saint Luke's Cancer Institute - Nampa
Nampa, Idaho, 83687
Site Public Contact, 208-381-2774, eslinget@slhs.org
Alison K. Conlin
- Recruiting
UPMC Cancer Center-Natrona Heights
Natrona Heights, Pennsylvania, 15065
Site Public Contact, 724-230-3030
Adam Olson
- Recruiting
Baptist Memorial Hospital and Cancer Center-Union County
New Albany, Mississippi, 38652
Site Public Contact, 901-226-1366, BCCclintrials@bmhcc.org
Andrew J. Benefield
- Recruiting
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, 08903
Site Public Contact, 732-235-7356
Tina Mayer
- Recruiting
UPMC Hillman Cancer Center - New Castle
New Castle, Pennsylvania, 16105
Site Public Contact, 412-389-5208, haneydl@upmc.edu
Adam Olson
- Recruiting
Cancer Center of Western Wisconsin
New Richmond, Wisconsin, 54017
Site Public Contact, 952-993-1517, mmcorc@healthpartners.com
David M. King
- Recruiting
Mount Sinai Union Square
New York, New York, 10003
Site Public Contact, 212-824-7309, CCTO@mssm.edu
Bobby Liaw
- Recruiting
Mount Sinai Chelsea
New York, New York, 10011
Site Public Contact, 212-824-7309, CCTO@mssm.edu
Bobby Liaw
- Recruiting
Mount Sinai West
New York, New York, 10019
Site Public Contact, 212-824-7309, CCTO@mssm.edu
Bobby Liaw
- Recruiting
Mount Sinai Hospital
New York, New York, 10029
Site Public Contact, 212-824-7309, CCTO@mssm.edu
Bobby Liaw
- Recruiting
New York Proton Center
New York, New York, 10035
Site Public Contact, 646-968-9031, ichoi@nyproton.com
Irini Yacoub
- Recruiting
Manhattan Eye Ear and Throat Hospital
New York, New York, 10065
Site Public Contact, 212-434-4460
Clary Evans
- Recruiting
Lenox Hill Hospital
New York, New York, 10075
Site Public Contact, 516-734-8896
Clary Evans
- Recruiting
Providence Newberg Medical Center
Newberg, Oregon, 97132
Site Public Contact, 503-215-2614, CanRsrchStudies@providence.org
Alison K. Conlin
- Recruiting
Cancer Care Center of O'Fallon
O'Fallon, Illinois, 62269
Site Public Contact, 217-876-4762, morganthaler.jodi@mhsil.com
Bryan A. Faller
- Recruiting
HSHS Saint Elizabeth's Hospital
O'Fallon, Illinois, 62269
Site Public Contact, 217-876-4762, morganthaler.jodi@mhsil.com
Bryan A. Faller
- Recruiting
Northwestern Medicine Oak Brook
Oak Brook, Illinois, 60523
Site Public Contact, nctnprogram_rhlccc@northwestern.edu
Sean Sachdev
- Recruiting
Rush MD Anderson Cancer Center at Rush Oak Park
Oak Park, Illinois, 60304
Site Public Contact, 312-226-2371, Cancer_Studies@rush.edu
Dian Wang
- Recruiting
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104
Site Public Contact, 405-271-8777, ou-clinical-trials@ouhsc.edu
Tyler Gunter
- Recruiting
Mercy Hospital Oklahoma City
Oklahoma City, Oklahoma, 73120
Site Public Contact, 405-752-3402
Jay W. Carlson
- Suspended
Alegent Health Immanuel Medical Center
Omaha, Nebraska, 68122
- Recruiting
Alegent Health Bergan Mercy Medical Center
Omaha, Nebraska, 68124
Site Public Contact, 720-874-1881, ResearchInstituteInquiries@CommonSpirit.org
Shahzad Siddique
- Suspended
Alegent Health Lakeside Hospital
Omaha, Nebraska, 68130
- Recruiting
Providence Willamette Falls Medical Center
Oregon City, Oregon, 97045
Site Public Contact, 503-215-2614, CanRsrchStudies@providence.org
Alison K. Conlin
- Recruiting
Northwestern Medicine Orland Park
Orland Park, Illinois, 60462
Site Public Contact, nctnprogram_rhlccc@northwestern.edu
Sean Sachdev
- Recruiting
Lake Regional Hospital
Osage Beach, Missouri, 65065
Site Public Contact, 573-302-2768, clinicaltrials@lakeregional.com
Jay W. Carlson
- Recruiting
Illinois CancerCare-Ottawa Clinic
Ottawa, Illinois, 61350
Site Public Contact, 309-243-3605, andersonj@illinoiscancercare.com
Bryan A. Faller
- Recruiting
Baptist Memorial Hospital and Cancer Center-Oxford
Oxford, Mississippi, 38655
Site Public Contact, 901-226-1366, BCCclintrials@bmhcc.org
Andrew J. Benefield
- Active, not recruiting
VA Palo Alto Health Care System
Palo Alto, California, 94304
- Suspended
AdventHealth Parker
Parker, Colorado, 80138
- Recruiting
Illinois CancerCare-Pekin
Pekin, Illinois, 61554
Site Public Contact, 309-243-3605, andersonj@illinoiscancercare.com
Bryan A. Faller
- Recruiting
Illinois CancerCare-Peoria
Peoria, Illinois, 61615
Site Public Contact, 309-243-3605, andersonj@illinoiscancercare.com
Bryan A. Faller
- Recruiting
Methodist Medical Center of Illinois
Peoria, Illinois, 61636
Site Public Contact, 309-243-3605, andersonj@illinoiscancercare.com
Bryan A. Faller
- Recruiting
Illinois CancerCare-Peru
Peru, Illinois, 61354
Site Public Contact, 309-243-3605, andersonj@illinoiscancercare.com
Bryan A. Faller
- Suspended
Valley Radiation Oncology
Peru, Illinois, 61354
- Recruiting
Penn Presbyterian Medical Center
Philadelphia, Pennsylvania, 19104
Site Public Contact, 215-349-8245, PMCancerResearch@pennmedicine.upenn.edu
Neha Vapiwala
- Recruiting
University of Pennsylvania/Abramson Cancer Center
Philadelphia, Pennsylvania, 19104
Site Public Contact, 215-349-8245, PMCancerResearch@pennmedicine.upenn.edu
Neha Vapiwala
- Recruiting
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, 19107
Site Public Contact, 215-600-9151, ONCTrialNow@jefferson.edu
Jessie W. DiNome
- Active, not recruiting
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111
- Active, not recruiting
Temple University Hospital
Philadelphia, Pennsylvania, 19140
- Recruiting
Cancer Center at Saint Joseph's
Phoenix, Arizona, 85004
Site Public Contact, 720-874-1881, ResearchInstituteInquiries@CommonSpirit.org
Shahzad Siddique
- Recruiting
Mercy Hospital Pittsburg
Pittsburg, Kansas, 66762
Site Public Contact, 888-446-3729
Jay W. Carlson
- Recruiting
UPMC-Magee Womens Hospital
Pittsburgh, Pennsylvania, 15213
Site Public Contact, 412-647-2811
Adam Olson
- Recruiting
UPMC-Saint Margaret
Pittsburgh, Pennsylvania, 15215
Site Public Contact, 412-784-4900
Adam Olson
- Recruiting
UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania, 15232
Site Public Contact, 412-647-8073
Adam Olson
- Recruiting
UPMC-Shadyside Hospital
Pittsburgh, Pennsylvania, 15232
Site Public Contact, 412-621-2334
Adam Olson
- Recruiting
UPMC-Passavant Hospital
Pittsburgh, Pennsylvania, 15237
Site Public Contact, 412-367-6454
Adam Olson
- Recruiting
UPMC-Saint Clair Hospital Cancer Center
Pittsburgh, Pennsylvania, 15243
Site Public Contact, 412-502-3920
Adam Olson
- Active, not recruiting
MaineHealth Maine Medical Center - Portland
Portland, Maine, 04102
- Active, not recruiting
Legacy Good Samaritan Hospital and Medical Center
Portland, Oregon, 97210
- Recruiting
Providence Portland Medical Center
Portland, Oregon, 97213
Site Public Contact, 503-215-2614, CanRsrchStudies@providence.org
Alison K. Conlin
- Recruiting
Providence Saint Vincent Medical Center
Portland, Oregon, 97225
Site Public Contact, 503-215-2614, CanRsrchStudies@providence.org
Alison K. Conlin
- Recruiting
Oregon Health and Science University
Portland, Oregon, 97239
Site Public Contact, 503-494-1080, trials@ohsu.edu
Arthur Y. Hung
- Recruiting
Kootenai Clinic Cancer Services - Post Falls
Post Falls, Idaho, 83854
Site Public Contact, 406-969-6060, mccinfo@mtcancer.org
John M. Schallenkamp
- Recruiting
Illinois CancerCare-Princeton
Princeton, Illinois, 61356
Site Public Contact, 309-243-3605, andersonj@illinoiscancercare.com
Bryan A. Faller
- Recruiting
Saint Mary Corwin Medical Center
Pueblo, Colorado, 81004
Site Public Contact, 720-874-1881, ResearchInstituteInquiries@CommonSpirit.org
Shahzad Siddique
- Recruiting
Queens Cancer Center
Rego Park, New York, 11374
Site Public Contact, 718-312-3446
Clary Evans
- Recruiting
Aspirus Cancer Care-Rhinelander-James Beck Cancer Center
Rhinelander, Wisconsin, 54501
Site Public Contact, 715-847-2353, Beth.Knetter@aspirus.org
Andrew J. Huang
- Recruiting
Marshfield Medical Center-Rice Lake
Rice Lake, Wisconsin, 54868
Site Public Contact, 800-782-8581, oncology.clinical.trials@marshfieldresearch.org
Isaac K. Yeboah
- Recruiting
UT Southwestern Clinical Center at Richardson/Plano
Richardson, Texas, 75080
Site Public Contact, 972-669-7044, Suzanne.cole@utsouthwestern.edu
Kevin D. Courtney
- Suspended
ECU Health Oncology Richlands
Richlands, North Carolina, 28574
- Recruiting
VCU Massey Comprehensive Cancer Center
Richmond, Virginia, 23298
Site Public Contact, 804-628-6430, CTOclinops@vcu.edu
Alfredo I. Urdaneta
- Recruiting
North Memorial Medical Health Center
Robbinsdale, Minnesota, 55422
Site Public Contact, 952-993-1517, mmcorc@healthpartners.com
David M. King
- Recruiting
UW Health Carbone Cancer Center Rockford
Rockford, Illinois, 61114
Site Public Contact, 779-696-9378, lkline@uwhealth.org
Fahrettin Covut
- Recruiting
Mercy Cancer Center - Rocklin
Rocklin, California, 95765
Site Public Contact, 720-874-1881, ResearchInstituteInquiries@CommonSpirit.org
Shahzad Siddique
- Recruiting
Mercy Clinic-Rolla-Cancer and Hematology
Rolla, Missouri, 65401
Site Public Contact, 573-458-6379
Jay W. Carlson
- Recruiting
Phelps Health Delbert Day Cancer Institute
Rolla, Missouri, 65401
Site Public Contact, 573-458-7504, research@phelpshealth.org
Jay W. Carlson
- Recruiting
Mercy Cancer Center - Sacramento
Sacramento, California, 95816
Site Public Contact, 720-874-1881, ResearchInstituteInquiries@CommonSpirit.org
Shahzad Siddique
- Recruiting
Coborn Cancer Center at Saint Cloud Hospital
Saint Cloud, Minnesota, 56303
Site Public Contact, 877-229-4907, coborncancercenter@centracare.com
Donald J. Jurgens
- Recruiting
Heartland Regional Medical Center
Saint Joseph, Missouri, 64506
Site Public Contact, 816-271-7937, Trisha.England2@mymlc.com
Jay W. Carlson
- Recruiting
Park Nicollet Clinic - Saint Louis Park
Saint Louis Park, Minnesota, 55416
Site Public Contact, 952-993-1517, mmcorc@healthpartners.com
David M. King
- Recruiting
Regions Hospital
Saint Paul, Minnesota, 55101
Site Public Contact, 952-993-1517, mmcorc@healthpartners.com
David M. King
- Recruiting
United Hospital
Saint Paul, Minnesota, 55102
Site Public Contact, 952-993-1517, mmcorc@healthpartners.com
David M. King
- Recruiting
Sainte Genevieve County Memorial Hospital
Sainte Genevieve, Missouri, 63670
Site Public Contact, 314-996-5569
Bryan A. Faller
- Active, not recruiting
Audie L Murphy VA Hospital
San Antonio, Texas, 78229
- Active, not recruiting
University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78229
- Recruiting
UC San Diego Medical Center - Hillcrest
San Diego, California, 92103
Site Public Contact, rhabbaba@health.ucsd.edu
James M. Randall
- Recruiting
Pacific Central Coast Health Center-San Luis Obispo
San Luis Obispo, California, 93401
Site Public Contact, 720-874-1881, ResearchInstituteInquiries@CommonSpirit.org
Shahzad Siddique
- Active, not recruiting
MaineHealth Cancer Care and IV Therapy - Sanford
Sanford, Maine, 04073
- Active, not recruiting
MaineHealth Cancer Care Center of York County
Sanford, Maine, 04073
- Recruiting
Mission Hope Medical Oncology - Santa Maria
Santa Maria, California, 93444
Site Public Contact, 720-874-1881, ResearchInstituteInquiries@CommonSpirit.org
Shahzad Siddique
- Active, not recruiting
MaineHealth Maine Medical Center- Scarborough
Scarborough, Maine, 04074
- Recruiting
Swedish Medical Center-Ballard Campus
Seattle, Washington, 98107
Site Public Contact, 206-215-3086, PCRC-NCORP@Swedish.org
Alison K. Conlin
- Recruiting
Fred Hutchinson Cancer Center
Seattle, Washington, 98109
Site Public Contact, 800-804-8824
Jonathan J. Chen
- Recruiting
Swedish Medical Center-Cherry Hill
Seattle, Washington, 98122-5711
Site Public Contact, 206-215-3086, PCRC-NCORP@Swedish.org
Alison K. Conlin
- Recruiting
Swedish Medical Center-First Hill
Seattle, Washington, 98122
Site Public Contact, 206-215-2343, PCRC-NCORP@Swedish.org
Alison K. Conlin
- Recruiting
FHCC at Northwest Hospital
Seattle, Washington, 98133
Site Public Contact, 206-606-5800
Jonathan J. Chen
- Recruiting
University of Washington Medical Center - Montlake
Seattle, Washington, 98195
Site Public Contact, 800-804-8824
Jonathan J. Chen
- Recruiting
PeaceHealth United General Medical Center
Sedro-Woolley, Washington, 98284
Site Public Contact, 360-788-8239, achapman1@peacehealth.org
Alison K. Conlin
- Recruiting
UPMC Cancer Center at UPMC Northwest
Seneca, Pennsylvania, 16346
Site Public Contact, 814-676-7900
Adam Olson
- Recruiting
Saint Francis Regional Medical Center
Shakopee, Minnesota, 55379
Site Public Contact, 952-993-1517, mmcorc@healthpartners.com
David M. King
- Suspended
Welch Cancer Center
Sheridan, Wyoming, 82801
- Recruiting
Saint Joseph Medical Center Hematology and Oncology - Silverdale
Silverdale, Washington, 98383
Site Public Contact, 720-874-1881, ResearchInstituteInquiries@CommonSpirit.org
Shahzad Siddique
- Suspended
Sanford Cancer Center Oncology Clinic
Sioux Falls, South Dakota, 57104
- Suspended
Sanford USD Medical Center - Sioux Falls
Sioux Falls, South Dakota, 57117-5134
- Recruiting
Phelps Memorial Hospital Center
Sleepy Hollow, New York, 10591
Site Public Contact, 914-366-1600
Clary Evans
- Recruiting
Robert Wood Johnson University Hospital Somerset
Somerville, New Jersey, 08876
Site Public Contact, 908-685-2481, Siby.Varughese@rwjbh.org
Tina Mayer
- Recruiting
City of Hope South Pasadena
South Pasadena, California, 91030
Site Public Contact, 800-826-4673, becomingapatient@coh.org
Scott M. Glaser
- Active, not recruiting
MaineHealth Cancer Care and IV Therapy - South Portland
South Portland, Maine, 04106
- Recruiting
Cancer Care Northwest - Spokane South
Spokane, Washington, 99202
Site Public Contact, 509-228-1680, research@ccnw.net
Alison K. Conlin
- Recruiting
Cancer Care Northwest-North Spokane
Spokane, Washington, 99218
Site Public Contact, 509-228-1680, research@ccnw.net
Alison K. Conlin
- Recruiting
Southern Illinois University School of Medicine
Springfield, Illinois, 62702
Site Public Contact, 217-545-7929
Bryan A. Faller
- Recruiting
Springfield Clinic
Springfield, Illinois, 62702
Site Public Contact, 800-444-7541
Bryan A. Faller
- Recruiting
Springfield Memorial Hospital
Springfield, Illinois, 62781
Site Public Contact, 217-528-7541, pallante.beth@mhsil.com
Bryan A. Faller
- Recruiting
Mercy Hospital Springfield
Springfield, Missouri, 65804
Site Public Contact, 417-269-4520
Jay W. Carlson
- Recruiting
CoxHealth South Hospital
Springfield, Missouri, 65807
Site Public Contact, 417-269-4520
Jay W. Carlson
- Recruiting
Washington University School of Medicine
St Louis, Missouri, 63110
Site Public Contact, 800-600-3606, info@siteman.wustl.edu
Jeff M. Michalski
- Recruiting
Mercy Hospital South
St Louis, Missouri, 63128
Site Public Contact, 314-525-6042, Danielle.Werle@mercy.net
Jay W. Carlson
- Recruiting
Siteman Cancer Center-South County
St Louis, Missouri, 63129
Site Public Contact, 800-600-3606, info@siteman.wustl.edu
Jeff M. Michalski
- Recruiting
Missouri Baptist Medical Center
St Louis, Missouri, 63131
Site Public Contact, 314-996-5569
Bryan A. Faller
- Recruiting
Siteman Cancer Center at Christian Hospital
St Louis, Missouri, 63136
Site Public Contact, 800-600-3606, info@siteman.wustl.edu
Jeff M. Michalski
- Recruiting
Mercy Hospital Saint Louis
St Louis, Missouri, 63141
Site Public Contact, 314-251-7066
Jay W. Carlson
- Recruiting
Aspirus Cancer Care - Stevens Point
Stevens Point, Wisconsin, 54481
Site Public Contact, 715-847-2353, Beth.Knetter@aspirus.org
Andrew J. Huang
- Recruiting
Marshfield Medical Center-River Region at Stevens Point
Stevens Point, Wisconsin, 54482
Site Public Contact, 800-782-8581, oncology.clinical.trials@marshfieldresearch.org
Isaac K. Yeboah
- Recruiting
Lakeview Hospital
Stillwater, Minnesota, 55082
Site Public Contact, 952-993-1517, mmcorc@healthpartners.com
David M. King
About this study
Official title: Phase III Study of Local or Systemic Therapy INtensification DIrected by PET in Prostate CAncer Patients With Post-ProstaTEctomy Biochemical Recurrence (INDICATE)
This phase III trial tests two questions by two separate comparisons of therapies. The first question is whether enhanced therapy (apalutamide in combination with abiraterone + prednisone) added to standard of care (prostate radiation therapy and short term androgen deprivation) is more effective compared to standard of care alone in patients with prostate cancer who experience biochemical recurrence (a rise in the blood level of prostate specific antigen [PSA] after surgical removal of the prostate cancer).
A second question tests treatment in patients with biochemical recurrence who show prostate cancer spreading outside the pelvis (metastasis) by positron emission tomography (PET) imaging. In these patients, the benefit of adding metastasis-directed radiation to enhanced therapy (apalutamide in combination with abiraterone + prednisone) is tested.
Diagnostic procedures, such as PET, may help doctors look for cancer that has spread to the pelvis. Androgens are hormones that may cause the growth of prostate cancer cells. Apalutamide may help fight prostate cancer by blocking the use of androgens by the tumor cells. Metastasis-directed targeted radiation therapy uses high energy rays to kill tumor cells and shrink tumors that have spread. This trial may help doctors determine if using PET results to deliver more tailored treatment (i.e., adding apalutamide, with or without targeted radiation therapy, to standard of care treatment) works better than standard of care treatment alone in patients with biochemical recurrence of prostate cancer.
Read the detailed description
PRIMARY OBJECTIVES:
- For patients without PET-evidence of extrapelvic metastases, to evaluate whether the addition of enhanced systemic therapy to standard of care (SOC) salvage radiation therapy (RT) could prolong progression-free survival (PFS).
II. For patients with PET-evidence of extrapelvic metastases, to evaluate whether the addition of metastasis-directed RT to enhanced systemic therapy and SOC salvage RT could prolong PFS.
III. To compare overall quality of life, measured by Functional Assessment of Cancer Therapy - Prostate (FACT-P) total score, at 6 months between the two sets of treatment arms (A with B and C with D). (QUALITY OF LIFE [QOL] OBJECTIVE)
SECONDARY OBJECTIVES:
- To evaluate overall survival in each arm. II. To evaluate event-free survival in each arm. III. To evaluate time to prostate-specific antigen (PSA) progression in each arm.
IV. To assess the incidence of adverse events with the addition of enhanced systemic therapy in patients without PET-evidence of extrapelvic metastases.
- To assess the incidence of adverse events with local ablative metastasis-directed RT for PET-positive metastatic disease in patients with PET-evidence of extrapelvic metastases.
VI. To estimate the detection rate of PET at the patient and regional level, and to evaluate its concordance with the follow-up Food and Drug Administration (FDA)-approved conventional imaging modalities (CIM) (as available) considered standard-of-care per institution, including computed tomography (CT), bone scintigraphy, magnetic resonance imaging (MRI) and PET imaging.
VII. To determine the distribution of PET-positive lesions among anatomic sites (prostate fossa, intrapelvic soft tissue/lymph node, extrapelvic soft tissue/lymph node, and bone metastases) in patients with post-radical prostatectomy (RP) biochemical recurrence (BCR), correlated with PSA (level, doubling time, velocity) and other relevant clinical parameters.
VIII. To compare the change in overall QOL, measured by FACT-P total score, from baseline to 6 months between the two sets of treatment arms (A with B and C with D). (QOL OBJECTIVE) IX. To compare patient-reported fatigue (Functional Assessment of Chronic Illness Therapy [FACIT]-Fatigue scores) at 6 months between the two sets of treatment arms (A with B and C with D). (QOL OBJECTIVE) X. To compare patient-reported overall QOL (FACT-P scores), fatigue (FACIT-Fatigue scores) and pain interference (patient reported outcomes measurement information system [PROMIS] Pain Interference Short Form 4a) between the two sets of treatment arms (A with B and C with D) at the time of disease progression. (QOL OBJECTIVE)
EXPLORATORY OBJECTIVES:
I.To determine the value of repeat PET (PET2) at time of second PSA progression, clinical concern for progression, or 12 months after completion of enhanced systemic therapy, whichever comes first to assess response to therapy (enhanced systemic therapy +/- focal RT and/or androgen deprivation therapy [ADT]) compared to available standard response assessments (PSA and conventional imaging modalities [CIM]).
II. To compare cognitive function, measured by FACT - cognitive function (Cog) peritoneal cancer index (PCI) and total scores, between the three treatment arms receiving enhanced systemic treatment with ADT and apalutamide (Arms B, C, and D) and antiandrogen therapy (ADT) alone (Arm A) at 6 and 12 month. (QOL OBJECTIVE) III. To compare the change in cognitive function, measured by change in FACT-Cog PCI and total scores, from baseline to 6 and baseline to 12 months, between the three treatment arms receiving enhanced systemic treatment with ADT and apalutamide (Arms B, C, and D) and ADT alone (Arm A) at 6 and 12 months. (QOL OBJECTIVE) IV. To characterize longitudinal change in cognitive function between baseline and 24 months in patients with prostate cancer receiving treatment for biochemical recurrence (BCR) and define clinical and disease related characteristics associated with greater cognitive change by the FACT-Cog PCI and total scores. (QOL OBJECTIVE)
OUTLINE:
STEP 0: Patients undergo SOC PET/CT or PET/MR scan at baseline. Patients randomized to Arms C or D and receiving fluciclovine F18 intravenously (IV) undergo a repeat PET2 at time of PSA progression or clinical concerns for progression or 12 months after completion of enhanced systemic therapy, whichever occurs first. Patients in Arm C or D using another tracer for PET1 do not undergo PET2.
STEP 1: Patients are randomized to 1 of 4 arms based on results of fluciclovine F18 PET/CT or PET/MR in Step 0.
ARM A (PET NEGATIVE FOR EXTRA PELVIC-METASTASES): Patients undergo SOC external beam radiation therapy (EBRT) for 6 months. Patients also receive goserelin acetate subcutaneously (SC), leuprolide acetate intramuscularly (IM), triptorelin IM, relugolix orally (PO), or degarelix SC for 6 months starting up to 3 months prior to EBRT but no later than 7 days after start of EBRT. All treatment continues for 6 months in the absence of disease progression or unacceptable toxicity.
ARM B (PET NEGATIVE FOR EXTRA PELVIC-METASTASES): Patients undergo SOC EBRT and receive goserelin acetate SC, leuprolide acetate IM, triptorelin IM, relugolix PO, or degarelix SC as in Arm A. Patients also receive apalutamide PO once daily (QD) for 6 months in the absence of disease progression or unacceptable toxicity.
ARM C: (PET POSITIVE FOR EXTRA PELVIC-METASTASES): Patients undergo SOC EBRT and receive goserelin acetate SC, leuprolide acetate IM, triptorelin IM, relugolix PO, or degarelix SC as in Arm A. Patients also receive apalutamide PO QD as in Arm B.
ARM D (PET POSITIVE FOR EXTRA PELVIC-METASTASES): Patients undergo SOC EBRT and receive goserelin acetate SC, leuprolide acetate IM, triptorelin IM, relugolix PO, or degarelix SC as in Arm A and apalutamide PO QD as in Arm B. Patients also undergo stereotactic body radiation therapy (SBRT) or 3-dimensional (3D) conformal radiation therapy (CRT), intensity-modulated radiation therapy (IMRT) (including volume modulated arc therapy [VMAT]), and intensity-modulated proton therapy (IMPT) over 3-10 fractions in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up every 3 months for the first 2 years, every 6 months for years 3-5, and then annually for years 6-10.
- Conditions
- Biochemically Recurrent Prostate Carcinoma, Metastatic Prostate Carcinoma, Prostate Adenocarcinoma, Stage IVB Prostate Cancer AJCC v8
- Being tested
- 3-Dimensional Conformal Radiation Therapy, Apalutamide, Computed Tomography, Degarelix, External Beam Radiation Therapy
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3-Dimensional Conformal Radiation TherapyRadiation
Also called 3-dimensional radiation therapy, 3D Conformal, 3D CONFORMAL RADIATION THERAPY, 3D CRT
Undergo 3D CRT
ApalutamideDrug
Also called ARN 509, ARN-509, ARN509, Erleada
Given PO
Computed TomographyProcedure or surgery
Also called CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography
Undergo PET/CT
DegarelixDrug
Also called FE200486, Firmagon
Given SC
External Beam Radiation TherapyRadiation
Also called Definitive Radiation Therapy, EBRT, External Beam Radiation, External Beam Radiotherapy
Undergo EBRT
Fluciclovine F18Other
Also called (18F)Fluciclovine, (18F)GE-148, 18F-Fluciclovine, [18F]FACBC
Given IV
Goserelin AcetateDrug
Also called ZDX, Zoladex
Given SC
Intensity-Modulated Proton TherapyProcedure or surgery
Also called IMPT
Undergo IMPT
Intensity-Modulated Radiation TherapyRadiation
Also called IMRT, Intensity modulated radiation therapy (procedure), Intensity Modulated RT, Intensity-Modulated Radiotherapy
Undergo IMRT
Leuprolide AcetateDrug
Also called A-43818, Abbott 43818, Abbott-43818, Carcinil
Given IM
Magnetic Resonance ImagingProcedure or surgery
Also called Magnetic Resonance, Magnetic resonance imaging (procedure), Magnetic Resonance Imaging Scan, Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance
Undergo PET/MR
Positron Emission TomographyProcedure or surgery
Also called Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron emission tomography (procedure)
Undergo PET/CT or PET/MR
Quality-of-Life AssessmentOther
Also called Quality of Life Assessment
Ancillary studies
Questionnaire AdministrationOther
Ancillary studies
RelugolixDrug
Also called N-(4-(1-((2,6-Difluorophenyl)methyl)-5-((dimethylamino)methyl)-1,2,3,4-tetrahydro-3-(6-methoxy-3-pyridazinyl)-2,4-dioxothieno(2,3-d)pyrimidin-6-yl)phenyl)-N'-methoxyurea, Orgovyx, TAK 385, TAK-385
Given PO
Stereotactic Body Radiation TherapyRadiation
Also called SABR, SBRT, Stereotactic Ablative Body Radiation Therapy
Undergo SBRT
TriptorelinDrug
Also called 6-D-Tryptophan-LH-RH, 6-D-Tryptophanluteinizing Hormone-releasing Factor, AY-25650, CL-118,532
Given IM
Volume Modulated Arc TherapyRadiation
Also called VMAT, Volumetric Modulated Arc Therapy (procedure)
Undergo VMAT
| Study group | Role | What they receive |
|---|---|---|
| Arm A (EBRT, short-term androgen deprivation therapy [STAD]) | Active comparator | STEP 0: Patients undergo SOC PET/CT or PET/MR scan at baseline. Patients randomized to Arms C or D and receiving fluciclovine F18 IV undergo a repeat PET2 at time of PSA progression or clinical concerns for progression or 12 months after completion of enhanced systemic therapy, whichever occurs first. Patients in Arm C or D using another tracer for PET1 do not undergo PET2.
STEP 1: Patients who are PET negative for extera pelvic metastases undergo SOC EBRT for 6 months. Patients also receive goserelin acetate SC, leuprolide acetate IM, triptorelin IM, relugolix PO, or degarelix SC for 6 months starting up to 3 months prior to EBRT but no later than 7 days after start of EBRT. All treatment continues for 6 months in the absence of disease progression or unacceptable toxicity. Receives: Procedure: Computed Tomography; Drug: Degarelix; Radiation: External Beam Radiation Therapy; Other: Fluciclovine F18; Drug: Goserelin Acetate; Drug: Leuprolide Acetate; Procedure: Magnetic Resonance Imaging; Procedure: Positron Emission Tomography; Other: Quality-of-Life Assessment; Other: Questionnaire Administration; Drug: Relugolix; Drug: Triptorelin |
| Arm B (EBRT, STAD, apalutamide) | Experimental | STEP 0: Patients undergo SOC PET/CT or PET/MR scan at baseline. Patients randomized to Arms C or D and receiving fluciclovine F18 IV undergo a repeat PET2 at time of PSA progression or clinical concerns for progression or 12 months after completion of enhanced systemic therapy, whichever occurs first. Patients in Arm C or D using another tracer for PET1 do not undergo PET2.
STEP 1: Patients who are PET negative for extra pelvic metastases undergo SOC EBRT and receive goserelin acetate SC, leuprolide acetate IM, triptorelin IM, relugolix PO, or degarelix SC as in Arm A. Patients also receive apalutamide PO QD for 6 months in the absence of disease progression or unacceptable toxicity. Receives: Drug: Apalutamide; Procedure: Computed Tomography; Drug: Degarelix; Radiation: External Beam Radiation Therapy; Other: Fluciclovine F18; Drug: Goserelin Acetate; Drug: Leuprolide Acetate; Procedure: Magnetic Resonance Imaging; Procedure: Positron Emission Tomography; Other: Quality-of-Life Assessment; Other: Questionnaire Administration; Drug: Relugolix; Drug: Triptorelin |
| Arm C (EBRT, STAD, apalutamide) | Experimental | STEP 0: Patients undergo SOC PET/CT or PET/MR scan at baseline. Patients randomized to Arms C or D and receiving fluciclovine F18 IV undergo a repeat PET2 at time of PSA progression or clinical concerns for progression or 12 months after completion of enhanced systemic therapy, whichever occurs first. Patients in Arm C or D using another tracer for PET1 do not undergo PET2.
STEP 1: Patients who are PET positive for extra pelvic metastases undergo SOC EBRT and receive goserelin acetate SC, leuprolide acetate IM, triptorelin IM, relugolix PO, or degarelix SC as in Arm A. Patients also receive apalutamide PO QD as in Arm B. Receives: Drug: Apalutamide; Procedure: Computed Tomography; Drug: Degarelix; Radiation: External Beam Radiation Therapy; Other: Fluciclovine F18; Drug: Goserelin Acetate; Drug: Leuprolide Acetate; Procedure: Magnetic Resonance Imaging; Procedure: Positron Emission Tomography; Other: Quality-of-Life Assessment; Other: Questionnaire Administration; Drug: Relugolix; Drug: Triptorelin |
| Arm D (EBRT, STAD, apalutamide, RT) | Experimental | STEP 0: Patients undergo SOC PET/CT or PET/MR scan at baseline. Patients randomized to Arms C or D and receiving fluciclovine F18 IV undergo a repeat PET2 at time of PSA progression or clinical concerns for progression or 12 months after completion of enhanced systemic therapy, whichever occurs first. Patients in Arm C or D using another tracer for PET1 do not undergo PET2.
STEP 1: Patients who are PET positive for extra pelvic metastases undergo SOC EBRT and receive goserelin acetate SC, leuprolide acetate IM, triptorelin IM, relugolix PO, or degarelix SC as in Arm A and apalutamide PO QD as in Arm B. Patients also undergo SBRT or 3D CRT, IMRT (including VMAT), and IMPT over 3-10 fractions in the absence of disease progression or unacceptable toxicity. Receives: Radiation: 3-Dimensional Conformal Radiation Therapy; Drug: Apalutamide; Procedure: Computed Tomography; Drug: Degarelix; Radiation: External Beam Radiation Therapy; Other: Fluciclovine F18; Drug: Goserelin Acetate; Procedure: Intensity-Modulated Proton Therapy; Radiation: Intensity-Modulated Radiation Therapy; Drug: Leuprolide Acetate; Procedure: Magnetic Resonance Imaging; Procedure: Positron Emission Tomography; Other: Quality-of-Life Assessment; Other: Questionnaire Administration; Drug: Relugolix; Radiation: Stereotactic Body Radiation Therapy; Drug: Triptorelin; Radiation: Volume Modulated Arc Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival (PFS)
The power of the PFS analysis is 85% using one-sided 0.025 level stratified logrank test. The overall type I error will be controlled using an O'Brien-Fleming boundary function
Measured: From randomization to radiographic progression by conventional imaging or positron emission tomography (PET), symptomatic disease or death, whichever occurs first, assessed up to 10 years
PFS prolongation in patients without PET-evidence of extrapelvic metastases
Will evaluate whether the addition of enhanced systemic therapy to standard of care salvage therapy could prolong PFS in this patient population. Will be an intention-to-treat analysis of all randomized patients and performed in parallel with patients with PET-evidence of extrapelvic metastases.
Measured: Up to 10 years
PFS prolongation in patients with PET-evidence of extrapelvic metastases
Will evaluate whether the addition of metastasis-directed radiation therapy to standard of care salvage therapy and enhanced systemic therapy could prolong PFS in this patient population. Will be an intention-to-treat analysis of all randomized patients and performed in parallel without patients with PET-evidence of extrapelvic metastases.
Measured: Up to 10 years
Quality of life (QOL)
Descriptive statistics will be used to characterize QOL over time in each arm.
Measured: Up to 24 months
Secondary outcomes (12)
Overall survival (OS)
Will be characterized by the method of Kaplan and Meier and a logrank test will be used to compare OS between the two arms in each cohort.
Measured: From randomization to death or date last known alive, assessed up to 10 years
Event-free survival
Will be characterized by the method of Kaplan and Meier and a logrank test will be used to compare EFS between the two arms in each cohort.
Measured: From randomization to radiographic progression by conventional imaging or PET, symptomatic disease, or initiation of new treatment for the disease or death, whichever occurs first, assessed up to 10 years
Time to prostate-specific antigen (PSA) progression
Patients without any progression will be censored at the date of last disease assessment that shows free of PSA progression. Will be characterized by the method of Kaplan and Meier and a logrank test will be used to compare time to PSA progression between the two arms in each cohort.
Measured: From randomization to documented PSA progression or radiographic progression, whichever occurs first, assessed up to 10 years
Incidence of adverse events
Toxicity will be defined using the Common Terminology Criteria for Adverse Events.
Measured: Up to 10 years
Detection rate of fluciclovine F18 (18F-fluciclovine) PET
For the detection rate, the proportion of baseline standard of care 18F-fluciclovine PET (PET1) positive results at the patient and regional (prostate fossa, intrapelvic soft tissue/lymph node, extrapelvic soft tissue/lymph node, and bone metastases) level will be calculated and its 95% confidence interval will be estimated using the Exact method based on the binomial distribution.
Measured: At time of PSA recurrence, as clinically indicated or 12 months after completion of enhanced systemic therapy (whichever occurs first), assessed up to 10 years
Concordance of detection rate with the follow-up conventional imaging modalities (CIM)
Will use Cohen's Kappa coefficient to measure the agreement between dichotomized PET results and the dichotomized CIM results. Baseline CIM comparison will not be performed because as per our study eligibility criteria, baseline CIM will be negative for metastases.
Measured: At time of PSA recurrence, as clinically indicated or 12 months after completion of enhanced systemic therapy (whichever occurs first), assessed up to 10 years
Distribution of 18F-fluciclovine PET-positive lesions among anatomic sites
The rate of 18F-fluciclovine PET-positive lesions will be reported for each anatomic site, including prostate fossa, intrapelvic soft tissue/lymph node, extrapelvic soft tissue/lymph node, and bone metastases. Their confidence intervals will be estimated using the Exact method for the binomial distribution. To evaluate if PSA (level, doubling time, velocity) and other relevant clinical parameters affects the positivity distribution, will use the logistic regression to model with the binary outcome (positive vs. negative from PET) and covariates will include anatomic site, PSA, and other clinical parameters. Will test the interactions between anatomic site and PSA (plus other clinical parameters) to see if the positivity distribution across anatomic site may change according to the levels of the interacted terms. Will use the technique of generalized estimating equation to account for the outcome correlations within subjects.
Measured: Baseline
Value of repeat PET to assess response to therapy compared to standard response assessments
Analyses will be conducted to evaluate qualitative visual evidence of 18F-fluciclovine PET positive metastatic lesions and quantitative PET standardized-uptake value (SUV) changes on a lesion-to-lesion basis from 18F-fluciclovine PET1 (baseline) to PET2 on visually determined sites of recurrence and metastatic disease. This will be compared to reference standard-of-care conventional imaging (Prostate Cancer Working Group 2 criteria) and PSA response at PET2 time point to determine PET2 response to therapy. PET2 visual and quantitative assessment will also be compared to PFS in the time-to-event analysis using a log-rank test (PET2 visual assessment) and a Cox proportional hazards regression (PET2 quantitative assessment). PET SUV parameters to be obtained at PET1 and PET2 will include SUVmax, SUVpeak. PET SUV change from PET1 to PET2 will include absolute SUVmax and SUVpeak change (PET2-PET1) and percent change of SUVmax and SUVpeak (% change = 100*[(PET2-PET1)/PET1]).)
Measured: At time of second PSA recurrence or 12 months after completion of enhanced systemic therapy (whichever occurs first), assessed up to 10 years
Comparison - Functional Assessment of Cancer Therapy (FACT)- prostate (P)
For the PET-negative cohort, with 216 analyzable patients in each arm, the study will have about 84% power to detect a 6-point (0.29 standard deviation) difference between the two arms using a two-sample t test with two-sided type I error of 0.05. The power will be greater than 99% if the difference between the two arms is 10 points (0.48 standard deviation). For the PET-positive cohort, with 146 analyzable patients in each arm, the study will have 68% and 98% power to detect a 6-point (0.29 standard deviation) and a 10-point (0.48 standard deviation) differences between the two arms, respectively, using the same test.
Measured: At baseline and 3, 6, 9, 12 months
Change in FACT-P and Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue
A paired t test will be used to compare FACT-P scores at these two time points in each arm. A two-sample t test will be performed to compare the changes in FACT-P scores from baseline to 6 months between the two arms of each cohort. The FACIT-Fatigue scores at 6 months will be compared between the two arms of each cohort using a two-sample t test.
Measured: Baseline up to 6 months
QOL Assessments at Progression
A paired t test will be used to compare FACT-P total scores, FACIT-Fatigue scores and pain scores at these two time points in each arm. The changes in these scores from baseline to progression will be evaluated in each arm.
Measured: Up to 10 years
FACT- cognitive functioning (Cog)
Will be compared between two groups of patients on this study, patients receiving antiandrogen therapy (ADT) + apalutamide (Arms B, C and D) and patients receiving ADT alone (Arm A), at different time points. To ensure similarity of the three arms with systemic treatments (Arms B, C and D), a comparison in FACT-Cog total scores among these three arms will be performed using the Kruskal-Wallis test before combining them together to be compared with Arm A.
Measured: Up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2020
- Study start8 Oct 2020
- Primary completion31 Dec 2032 (estimated)
- Study completion31 Dec 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Biochemically Recurrent Prostate CarcinomaStudies of the same condition, open and under way.
- More trials run by ECOG-ACRIN Cancer Research GroupThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 804 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ECOG-ACRIN Cancer Research Group
- Sponsor type
- Research network
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Neha Vapiwala, Principal investigator, ECOG-ACRIN Cancer Research Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04423211
- Sponsor's protocol ID
- EA8191
- Other IDs
- NCI-2020-02686, EA8191, EA8191, U10CA180820
- Status last verified
- Jun 2026
- First submitted
- 5 Jun 2020
- Last updated
- 19 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Morgan TM, Boorjian SA, Buyyounouski MK, Chapin BF, Chen DYT, Cheng HH, Chou R, Jacene HA, Kamran SC, Kim SK, Kirkby E, Luckenbaugh AN, Nathanson BJ, Nyame YA, Posadas EM, Tran PT, Chen RC. Salvage Therapy for Prostate Cancer: AUA/ASTRO/SUO Guideline Part II: Treatment Delivery for Non-metastatic Biochemical Recurrence After Primary Radical Prostatectomy. J Urol. 2024 Apr;211(4):518-525. doi: 10.1097/JU.0000000000003891. Epub 2024 Feb 29.
PubMed 38421243
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase III Study of Local or Systemic Therapy INtensification DIrected by PET in Prostate CAncer Patients With Post-ProstaTEctomy Biochemical Recurrence (INDICATE)
- ClinicalTrials.gov ID
- NCT04423211
- Acronym / sponsor ID
- EA8191
- Conditions
- Biochemically Recurrent Prostate Carcinoma, Metastatic Prostate Carcinoma, Prostate Adenocarcinoma, Stage IVB Prostate Cancer AJCC v8
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 804 participants (estimated)
- Lead sponsor
- ECOG-ACRIN Cancer Research GroupResearch network
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 8 Oct 2020 (actual)
- Primary completion
- 31 Dec 2032 (estimated)
- Study completion
- 31 Dec 2032 (estimated)
- First posted
- 9 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This phase III trial tests two questions by two separate comparisons of therapies. The first question is whether enhanced therapy (apalutamide in combination with abiraterone + prednisone) added to standard of care (prostate radiation therapy and short term androgen deprivation) is more effective compared to standard of care alone in patients with prostate cancer who experience biochemical recurrence (a rise in the blood level of prostate specific antigen [PSA] after surgical removal of the prostate cancer).
A second question tests treatment in patients with biochemical recurrence who show prostate cancer spreading outside the pelvis (metastasis) by positron emission tomography (PET) imaging. In these patients, the benefit of adding metastasis-directed radiation to enhanced therapy (apalutamide in combination with abiraterone + prednisone) is tested.
Diagnostic procedures, such as PET, may help doctors look for cancer that has spread to the pelvis. Androgens are hormones that may cause the growth of prostate cancer cells. Apalutamide may help fight prostate cancer by blocking the use of androgens by the tumor cells. Metastasis-directed targeted radiation therapy uses high energy rays to kill tumor cells and shrink tumors that have spread. This trial may help doctors determine if using PET results to deliver more tailored treatment (i.e., adding apalutamide, with or without targeted radiation therapy, to standard of care treatment) works better than standard of care treatment alone in patients with biochemical recurrence of prostate cancer.
Detailed description
PRIMARY OBJECTIVES:
- For patients without PET-evidence of extrapelvic metastases, to evaluate whether the addition of enhanced systemic therapy to standard of care (SOC) salvage radiation therapy (RT) could prolong progression-free survival (PFS).
II. For patients with PET-evidence of extrapelvic metastases, to evaluate whether the addition of metastasis-directed RT to enhanced systemic therapy and SOC salvage RT could prolong PFS.
III. To compare overall quality of life, measured by Functional Assessment of Cancer Therapy - Prostate (FACT-P) total score, at 6 months between the two sets of treatment arms (A with B and C with D). (QUALITY OF LIFE [QOL] OBJECTIVE)
SECONDARY OBJECTIVES:
- To evaluate overall survival in each arm. II. To evaluate event-free survival in each arm. III. To evaluate time to prostate-specific antigen (PSA) progression in each arm.
IV. To assess the incidence of adverse events with the addition of enhanced systemic therapy in patients without PET-evidence of extrapelvic metastases.
- To assess the incidence of adverse events with local ablative metastasis-directed RT for PET-positive metastatic disease in patients with PET-evidence of extrapelvic metastases.
VI. To estimate the detection rate of PET at the patient and regional level, and to evaluate its concordance with the follow-up Food and Drug Administration (FDA)-approved conventional imaging modalities (CIM) (as available) considered standard-of-care per institution, including computed tomography (CT), bone scintigraphy, magnetic resonance imaging (MRI) and PET imaging.
VII. To determine the distribution of PET-positive lesions among anatomic sites (prostate fossa, intrapelvic soft tissue/lymph node, extrapelvic soft tissue/lymph node, and bone metastases) in patients with post-radical prostatectomy (RP) biochemical recurrence (BCR), correlated with PSA (level, doubling time, velocity) and other relevant clinical parameters.
VIII. To compare the change in overall QOL, measured by FACT-P total score, from baseline to 6 months between the two sets of treatment arms (A with B and C with D). (QOL OBJECTIVE) IX. To compare patient-reported fatigue (Functional Assessment of Chronic Illness Therapy [FACIT]-Fatigue scores) at 6 months between the two sets of treatment arms (A with B and C with D). (QOL OBJECTIVE) X. To compare patient-reported overall QOL (FACT-P scores), fatigue (FACIT-Fatigue scores) and pain interference (patient reported outcomes measurement information system [PROMIS] Pain Interference Short Form 4a) between the two sets of treatment arms (A with B and C with D) at the time of disease progression. (QOL OBJECTIVE)
EXPLORATORY OBJECTIVES:
I.To determine the value of repeat PET (PET2) at time of second PSA progression, clinical concern for progression, or 12 months after completion of enhanced systemic therapy, whichever comes first to assess response to therapy (enhanced systemic therapy +/- focal RT and/or androgen deprivation therapy [ADT]) compared to available standard response assessments (PSA and conventional imaging modalities [CIM]).
II. To compare cognitive function, measured by FACT - cognitive function (Cog) peritoneal cancer index (PCI) and total scores, between the three treatment arms receiving enhanced systemic treatment with ADT and apalutamide (Arms B, C, and D) and antiandrogen therapy (ADT) alone (Arm A) at 6 and 12 month. (QOL OBJECTIVE) III. To compare the change in cognitive function, measured by change in FACT-Cog PCI and total scores, from baseline to 6 and baseline to 12 months, between the three treatment arms receiving enhanced systemic treatment with ADT and apalutamide (Arms B, C, and D) and ADT alone (Arm A) at 6 and 12 months. (QOL OBJECTIVE) IV. To characterize longitudinal change in cognitive function between baseline and 24 months in patients with prostate cancer receiving treatment for biochemical recurrence (BCR) and define clinical and disease related characteristics associated with greater cognitive change by the FACT-Cog PCI and total scores. (QOL OBJECTIVE)
OUTLINE:
STEP 0: Patients undergo SOC PET/CT or PET/MR scan at baseline. Patients randomized to Arms C or D and receiving fluciclovine F18 intravenously (IV) undergo a repeat PET2 at time of PSA progression or clinical concerns for progression or 12 months after completion of enhanced systemic therapy, whichever occurs first. Patients in Arm C or D using another tracer for PET1 do not undergo PET2.
STEP 1: Patients are randomized to 1 of 4 arms based on results of fluciclovine F18 PET/CT or PET/MR in Step 0.
ARM A (PET NEGATIVE FOR EXTRA PELVIC-METASTASES): Patients undergo SOC external beam radiation therapy (EBRT) for 6 months. Patients also receive goserelin acetate subcutaneously (SC), leuprolide acetate intramuscularly (IM), triptorelin IM, relugolix orally (PO), or degarelix SC for 6 months starting up to 3 months prior to EBRT but no later than 7 days after start of EBRT. All treatment continues for 6 months in the absence of disease progression or unacceptable toxicity.
ARM B (PET NEGATIVE FOR EXTRA PELVIC-METASTASES): Patients undergo SOC EBRT and receive goserelin acetate SC, leuprolide acetate IM, triptorelin IM, relugolix PO, or degarelix SC as in Arm A. Patients also receive apalutamide PO once daily (QD) for 6 months in the absence of disease progression or unacceptable toxicity.
ARM C: (PET POSITIVE FOR EXTRA PELVIC-METASTASES): Patients undergo SOC EBRT and receive goserelin acetate SC, leuprolide acetate IM, triptorelin IM, relugolix PO, or degarelix SC as in Arm A. Patients also receive apalutamide PO QD as in Arm B.
ARM D (PET POSITIVE FOR EXTRA PELVIC-METASTASES): Patients undergo SOC EBRT and receive goserelin acetate SC, leuprolide acetate IM, triptorelin IM, relugolix PO, or degarelix SC as in Arm A and apalutamide PO QD as in Arm B. Patients also undergo stereotactic body radiation therapy (SBRT) or 3-dimensional (3D) conformal radiation therapy (CRT), intensity-modulated radiation therapy (IMRT) (including volume modulated arc therapy [VMAT]), and intensity-modulated proton therapy (IMPT) over 3-10 fractions in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up every 3 months for the first 2 years, every 6 months for years 3-5, and then annually for years 6-10.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Arm A (EBRT, short-term androgen deprivation therapy [STAD]) | Active comparator | Procedure: Computed Tomography, Drug: Degarelix, Radiation: External Beam Radiation Therapy, Other: Fluciclovine F18, Drug: Goserelin Acetate, Drug: Leuprolide Acetate, Procedure: Magnetic Resonance Imaging, Procedure: Positron Emission Tomography, Other: Quality-of-Life Assessment, Other: Questionnaire Administration, Drug: Relugolix, Drug: TriptorelinSTEP 0: Patients undergo SOC PET/CT or PET/MR scan at baseline. Patients randomized to Arms C or D and receiving fluciclovine F18 IV undergo a repeat PET2 at time of PSA progression or clinical concerns for progression or 12 months after completion of enhanced systemic therapy, whichever occurs first. Patients in Arm C or D using another tracer for PET1 do not undergo PET2. STEP 1: Patients who are PET negative for extera pelvic metastases undergo SOC EBRT for 6 months. Patients also receive goserelin acetate SC, leuprolide acetate IM, triptorelin IM, relugolix PO, or degarelix SC for 6 months starting up to 3 months prior to EBRT but no later than 7 days after start of EBRT. All treatment continues for 6 months in the absence of disease progression or unacceptable toxicity. |
| Arm B (EBRT, STAD, apalutamide) | Experimental | Drug: Apalutamide, Procedure: Computed Tomography, Drug: Degarelix, Radiation: External Beam Radiation Therapy, Other: Fluciclovine F18, Drug: Goserelin Acetate, Drug: Leuprolide Acetate, Procedure: Magnetic Resonance Imaging, Procedure: Positron Emission Tomography, Other: Quality-of-Life Assessment, Other: Questionnaire Administration, Drug: Relugolix, Drug: TriptorelinSTEP 0: Patients undergo SOC PET/CT or PET/MR scan at baseline. Patients randomized to Arms C or D and receiving fluciclovine F18 IV undergo a repeat PET2 at time of PSA progression or clinical concerns for progression or 12 months after completion of enhanced systemic therapy, whichever occurs first. Patients in Arm C or D using another tracer for PET1 do not undergo PET2. STEP 1: Patients who are PET negative for extra pelvic metastases undergo SOC EBRT and receive goserelin acetate SC, leuprolide acetate IM, triptorelin IM, relugolix PO, or degarelix SC as in Arm A. Patients also receive apalutamide PO QD for 6 months in the absence of disease progression or unacceptable toxicity. |
| Arm C (EBRT, STAD, apalutamide) | Experimental | Drug: Apalutamide, Procedure: Computed Tomography, Drug: Degarelix, Radiation: External Beam Radiation Therapy, Other: Fluciclovine F18, Drug: Goserelin Acetate, Drug: Leuprolide Acetate, Procedure: Magnetic Resonance Imaging, Procedure: Positron Emission Tomography, Other: Quality-of-Life Assessment, Other: Questionnaire Administration, Drug: Relugolix, Drug: TriptorelinSTEP 0: Patients undergo SOC PET/CT or PET/MR scan at baseline. Patients randomized to Arms C or D and receiving fluciclovine F18 IV undergo a repeat PET2 at time of PSA progression or clinical concerns for progression or 12 months after completion of enhanced systemic therapy, whichever occurs first. Patients in Arm C or D using another tracer for PET1 do not undergo PET2. STEP 1: Patients who are PET positive for extra pelvic metastases undergo SOC EBRT and receive goserelin acetate SC, leuprolide acetate IM, triptorelin IM, relugolix PO, or degarelix SC as in Arm A. Patients also receive apalutamide PO QD as in Arm B. |
| Arm D (EBRT, STAD, apalutamide, RT) | Experimental | Radiation: 3-Dimensional Conformal Radiation Therapy, Drug: Apalutamide, Procedure: Computed Tomography, Drug: Degarelix, Radiation: External Beam Radiation Therapy, Other: Fluciclovine F18, Drug: Goserelin Acetate, Procedure: Intensity-Modulated Proton Therapy, Radiation: Intensity-Modulated Radiation Therapy, Drug: Leuprolide Acetate, Procedure: Magnetic Resonance Imaging, Procedure: Positron Emission Tomography, Other: Quality-of-Life Assessment, Other: Questionnaire Administration, Drug: Relugolix, Radiation: Stereotactic Body Radiation Therapy, Drug: Triptorelin, Radiation: Volume Modulated Arc TherapySTEP 0: Patients undergo SOC PET/CT or PET/MR scan at baseline. Patients randomized to Arms C or D and receiving fluciclovine F18 IV undergo a repeat PET2 at time of PSA progression or clinical concerns for progression or 12 months after completion of enhanced systemic therapy, whichever occurs first. Patients in Arm C or D using another tracer for PET1 do not undergo PET2. STEP 1: Patients who are PET positive for extra pelvic metastases undergo SOC EBRT and receive goserelin acetate SC, leuprolide acetate IM, triptorelin IM, relugolix PO, or degarelix SC as in Arm A and apalutamide PO QD as in Arm B. Patients also undergo SBRT or 3D CRT, IMRT (including VMAT), and IMPT over 3-10 fractions in the absence of disease progression or unacceptable toxicity. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (36 listed)
- STEP 0: REGISTRATION ELIGIBILITY CRITERIA
- Patient must be male and >= 18 years of age.
- Patient must have had a radical prostatectomy (RP) as definitive therapy for histopathologically-proven prostatic adenocarcinoma
- Patient must have biochemical recurrence (BCR) after RP, defined as follows:
- Patients must have no definite evidence for extrapelvic metastatic disease by conventional imaging modalities (CIM) (CT abdomen/pelvis or MRI abdomen/pelvis AND bone scintigraphy, or equivalent), within 26 weeks prior to Step 0 registration. If a patient only has a study-eligible PET/CT or PET/MR (i.e., PET done without prior CIM): if the PET is negative for extrapelvic lesions, then baseline CIM is NOT required. If the PET positive for extrapelvic lesions, then patient should have a baseline CT/MRI for soft tissue lesions and/or a bone scan for osseous lesions
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 3-Dimensional Conformal Radiation TherapyAlso: 3-dimensional radiation therapy, 3D Conformal, 3D CONFORMAL RADIATION THERAPY, 3D CRTUndergo 3D CRT | Radiation | Arm D (EBRT, STAD, apalutamide, RT) |
| ApalutamideAlso: ARN 509, ARN-509, ARN509, ErleadaGiven PO | Drug | Arm B (EBRT, STAD, apalutamide), Arm C (EBRT, STAD, apalutamide), Arm D (EBRT, STAD, apalutamide, RT) |
| Computed TomographyAlso: CAT, CAT Scan, Computed Axial Tomography, Computerized Axial TomographyUndergo PET/CT | Procedure or surgery | Arm A (EBRT, short-term androgen deprivation therapy [STAD]), Arm B (EBRT, STAD, apalutamide), Arm C (EBRT, STAD, apalutamide), Arm D (EBRT, STAD, apalutamide, RT) |
| DegarelixAlso: FE200486, FirmagonGiven SC | Drug | Arm A (EBRT, short-term androgen deprivation therapy [STAD]), Arm B (EBRT, STAD, apalutamide), Arm C (EBRT, STAD, apalutamide), Arm D (EBRT, STAD, apalutamide, RT) |
| External Beam Radiation TherapyAlso: Definitive Radiation Therapy, EBRT, External Beam Radiation, External Beam RadiotherapyUndergo EBRT | Radiation | Arm A (EBRT, short-term androgen deprivation therapy [STAD]), Arm B (EBRT, STAD, apalutamide), Arm C (EBRT, STAD, apalutamide), Arm D (EBRT, STAD, apalutamide, RT) |
| Fluciclovine F18Also: (18F)Fluciclovine, (18F)GE-148, 18F-Fluciclovine, [18F]FACBCGiven IV | Other | Arm A (EBRT, short-term androgen deprivation therapy [STAD]), Arm B (EBRT, STAD, apalutamide), Arm C (EBRT, STAD, apalutamide), Arm D (EBRT, STAD, apalutamide, RT) |
| Goserelin AcetateAlso: ZDX, ZoladexGiven SC | Drug | Arm A (EBRT, short-term androgen deprivation therapy [STAD]), Arm B (EBRT, STAD, apalutamide), Arm C (EBRT, STAD, apalutamide), Arm D (EBRT, STAD, apalutamide, RT) |
| Intensity-Modulated Proton TherapyAlso: IMPTUndergo IMPT | Procedure or surgery | Arm D (EBRT, STAD, apalutamide, RT) |
| Intensity-Modulated Radiation TherapyAlso: IMRT, Intensity modulated radiation therapy (procedure), Intensity Modulated RT, Intensity-Modulated RadiotherapyUndergo IMRT | Radiation | Arm D (EBRT, STAD, apalutamide, RT) |
| Leuprolide AcetateAlso: A-43818, Abbott 43818, Abbott-43818, CarcinilGiven IM | Drug | Arm A (EBRT, short-term androgen deprivation therapy [STAD]), Arm B (EBRT, STAD, apalutamide), Arm C (EBRT, STAD, apalutamide), Arm D (EBRT, STAD, apalutamide, RT) |
| Magnetic Resonance ImagingAlso: Magnetic Resonance, Magnetic resonance imaging (procedure), Magnetic Resonance Imaging Scan, Medical Imaging, Magnetic Resonance / Nuclear Magnetic ResonanceUndergo PET/MR | Procedure or surgery | Arm A (EBRT, short-term androgen deprivation therapy [STAD]), Arm B (EBRT, STAD, apalutamide), Arm C (EBRT, STAD, apalutamide), Arm D (EBRT, STAD, apalutamide, RT) |
| Positron Emission TomographyAlso: Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron emission tomography (procedure)Undergo PET/CT or PET/MR | Procedure or surgery | Arm A (EBRT, short-term androgen deprivation therapy [STAD]), Arm B (EBRT, STAD, apalutamide), Arm C (EBRT, STAD, apalutamide), Arm D (EBRT, STAD, apalutamide, RT) |
| Quality-of-Life AssessmentAlso: Quality of Life AssessmentAncillary studies | Other | Arm A (EBRT, short-term androgen deprivation therapy [STAD]), Arm B (EBRT, STAD, apalutamide), Arm C (EBRT, STAD, apalutamide), Arm D (EBRT, STAD, apalutamide, RT) |
| Questionnaire AdministrationAncillary studies | Other | Arm A (EBRT, short-term androgen deprivation therapy [STAD]), Arm B (EBRT, STAD, apalutamide), Arm C (EBRT, STAD, apalutamide), Arm D (EBRT, STAD, apalutamide, RT) |
| RelugolixAlso: N-(4-(1-((2,6-Difluorophenyl)methyl)-5-((dimethylamino)methyl)-1,2,3,4-tetrahydro-3-(6-methoxy-3-pyridazinyl)-2,4-dioxothieno(2,3-d)pyrimidin-6-yl)phenyl)-N'-methoxyurea, Orgovyx, TAK 385, TAK-385Given PO | Drug | Arm A (EBRT, short-term androgen deprivation therapy [STAD]), Arm B (EBRT, STAD, apalutamide), Arm C (EBRT, STAD, apalutamide), Arm D (EBRT, STAD, apalutamide, RT) |
| Stereotactic Body Radiation TherapyAlso: SABR, SBRT, Stereotactic Ablative Body Radiation TherapyUndergo SBRT | Radiation | Arm D (EBRT, STAD, apalutamide, RT) |
| TriptorelinAlso: 6-D-Tryptophan-LH-RH, 6-D-Tryptophanluteinizing Hormone-releasing Factor, AY-25650, CL-118,532Given IM | Drug | Arm A (EBRT, short-term androgen deprivation therapy [STAD]), Arm B (EBRT, STAD, apalutamide), Arm C (EBRT, STAD, apalutamide), Arm D (EBRT, STAD, apalutamide, RT) |
| Volume Modulated Arc TherapyAlso: VMAT, Volumetric Modulated Arc Therapy (procedure)Undergo VMAT | Radiation | Arm D (EBRT, STAD, apalutamide, RT) |
Primary outcome
Progression-free survival (PFS)
Time frame: From randomization to radiographic progression by conventional imaging or positron emission tomography (PET), symptomatic disease or death, whichever occurs first, assessed up to 10 years
The power of the PFS analysis is 85% using one-sided 0.025 level stratified logrank test. The overall type I error will be controlled using an O'Brien-Fleming boundary function
PFS prolongation in patients without PET-evidence of extrapelvic metastases
Time frame: Up to 10 years
Will evaluate whether the addition of enhanced systemic therapy to standard of care salvage therapy could prolong PFS in this patient population. Will be an intention-to-treat analysis of all randomized patients and performed in parallel with patients with PET-evidence of extrapelvic metastases.
PFS prolongation in patients with PET-evidence of extrapelvic metastases
Time frame: Up to 10 years
Will evaluate whether the addition of metastasis-directed radiation therapy to standard of care salvage therapy and enhanced systemic therapy could prolong PFS in this patient population. Will be an intention-to-treat analysis of all randomized patients and performed in parallel without patients with PET-evidence of extrapelvic metastases.
Quality of life (QOL)
Time frame: Up to 24 months
Descriptive statistics will be used to characterize QOL over time in each arm.
12 secondary outcomes
Overall survival (OS)
Time frame: From randomization to death or date last known alive, assessed up to 10 years
Event-free survival
Time frame: From randomization to radiographic progression by conventional imaging or PET, symptomatic disease, or initiation of new treatment for the disease or death, whichever occurs first, assessed up to 10 years
Time to prostate-specific antigen (PSA) progression
Time frame: From randomization to documented PSA progression or radiographic progression, whichever occurs first, assessed up to 10 years
Incidence of adverse events
Time frame: Up to 10 years
Detection rate of fluciclovine F18 (18F-fluciclovine) PET
Time frame: At time of PSA recurrence, as clinically indicated or 12 months after completion of enhanced systemic therapy (whichever occurs first), assessed up to 10 years
Concordance of detection rate with the follow-up conventional imaging modalities (CIM)
Time frame: At time of PSA recurrence, as clinically indicated or 12 months after completion of enhanced systemic therapy (whichever occurs first), assessed up to 10 years
Distribution of 18F-fluciclovine PET-positive lesions among anatomic sites
Time frame: Baseline
Value of repeat PET to assess response to therapy compared to standard response assessments
Time frame: At time of second PSA recurrence or 12 months after completion of enhanced systemic therapy (whichever occurs first), assessed up to 10 years
Comparison - Functional Assessment of Cancer Therapy (FACT)- prostate (P)
Time frame: At baseline and 3, 6, 9, 12 months
Change in FACT-P and Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue
Time frame: Baseline up to 6 months
QOL Assessments at Progression
Time frame: Up to 10 years
FACT- cognitive functioning (Cog)
Time frame: Up to 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2026.
- Derived from this study: PubMed 38421243Morgan TM, Boorjian SA, Buyyounouski MK, Chapin BF, Chen DYT, Cheng HH, Chou R, Jacene HA, Kamran SC, Kim SK, Kirkby E, Luckenbaugh AN, Nathanson BJ, Nyame YA, Posadas EM, Tran PT, Chen RC. Salvage Therapy for Prostate Cancer: AUA/ASTRO/SUO Guideline Part II: Treatment Delivery for Non-metastatic Biochemical Recurrence After Primary Radical Prostatectomy. J Urol. 2024 Apr;211(4):518-525. doi: 10.1097/JU.0000000000003891. Epub 2024 Feb 29.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Anchorage Associates in Radiation Medicine
Anchorage, United States
Alaska Breast Care and Surgery LLC
Anchorage, United States
Alaska Oncology and Hematology LLC
Anchorage, United States
Neha Vapiwala principal investigator
ECOG-ACRIN Cancer Research Group
341 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing 3-Dimensional Conformal Radiation Therapy, Apalutamide and Computed Tomography in people with Biochemically Recurrent Prostate Carcinoma and Metastatic Prostate Carcinoma, run by ECOG-ACRIN Cancer Research Group at 341 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 36 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 341 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free survival (PFS) (time frame: From randomization to radiographic progression by conventional imaging or positron emission tomography (PET), symptomatic disease or death, whichever occurs first, assessed up to 10 years). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04423211, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2026.