Prostate AdenocarcinomaPhase 2NCT05806515
Carboplatin Chemotherapy Before Surgery for People With High-Risk Prostate Cancer and an Inherited BRCA1 or BRCA2 Gene Mutation
A Phase 2 study testing Biospecimen Collection, Carboplatin and Chest Radiography in people with Prostate Adenocarcinoma and Stage IIIB Prostate Cancer AJCC v8, run by SWOG Cancer Research Network at 133 sites in United States.
Trial summary
This phase II trial tests how well carboplatin before surgery works in treating patients with high-risk prostate cancer and an inherited BRCA1 or BRCA2 gene mutation. Carboplatin is in a class of medications known as platinum-containing compounds. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Adenocarcinoma, Stage IIIB Prostate Cancer AJCC v8, Stage IIIC Prostate Cancer AJCC v8
- What is being tested?
- Biospecimen Collection, Carboplatin and Chest Radiography
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 133 sitesUnited States
- Study dates
- 1 Mar 2024to Jun 2031
- Phase
- Phase 2
- 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
- Participant must have histologic diagnosis of prostate adenocarcinoma
- Participant must have high or very high-risk disease defined by at least one of the following:
- cT3a - cT4x
- Grade group 4 or 5 (Gleason sum 8-10)
- PSA > 20 ng/mL prior to registration
- Participant must have documented evidence of germline mutation (pathogenic/likely pathogenic variant) in BRCA2 or BRCA1 through testing in a Clinical Laboratory Improvement Act (CLIA)-certified lab
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- NOTE: Local lab report is sufficient for eligibility
- Participant may have initiated gonadotrophin releasing hormone (gnRH) agonist, gnRH antagonist, oral anti-androgen (e.g. bicalutamide, nilutamide, flutamide), or other agent intended to treat prostate cancer prior to registration. The effectiveness of the current depot of such treatment must not extend beyond 1 month after study registration. Agents listed above cannot be started after participant registration
- Participant must be >= 18 years old
- Participant must have Zubrod performance status of 0-2
- Participant must have a complete medical history and physical exam within 28 days prior to registration
- Absolute neutrophil count >= 1.5 x 10^3/uL (within 28 days prior to registration)
- Platelets >= 100 x 10^3/uL (within 28 days prior to registration)
- Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) =< 3 x institutional upper limit of normal (ULN) (within 28 days prior to registration)
- Participant must have a serum creatinine =< the institutional upper limit of normal (IULN) OR measured OR calculated creatinine clearance >= 50 mL/min using the following Cockcroft-Gault Formula. This specimen must have been drawn and processed within 28 days prior to registration
- Participant must have adequate cardiac function. Participants with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, must have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification within 28 days prior to registration. To be eligible for this trial, participants must be class 2B or better
- Participant with known human immunodeficiency virus (HIV)-infection must be receiving anti-retroviral therapy and have an undetectable viral load test within 6 months prior to registration
- Participant with history of chronic hepatitis B virus (HBV) infection must have undetectable HBV viral load on suppressive therapy within in 28 days prior to registration
- Participant with a history of hepatitis C virus (HCV) infection must have been treated and cured. For participants with HCV infection who are currently on treatment must have an undetectable HCV viral load within in 28 days prior to registration
- Participants who are of reproductive potential must have agreed to use an effective contraceptive method with details provided as a part of the consent process. A person who has semen likely to contain sperm is considered to be of "reproductive potential." In addition to routine contraceptive methods, "effective contraception" also includes refraining from sexual activity that might result in pregnancy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) including vasectomy with testing showing no sperm in the semen
- Prior to registration, participant must have had a urologic consult and be deemed a surgical candidate with known sites of disease deemed by the urologist to be potentially resectable
- Participants must be offered the opportunity to participate in specimen banking. With participant consent, specimens must be collected and submitted via the Southwest Oncology Group (SWOG) Specimen Tracking System
- NOTE: As a part of the OPEN registration process the treating institution's identity is provided in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered in the system
- Participants must be informed of the investigational nature of this study and must sign and give informed consent in accordance with institutional and federal guidelines
- For participants with impaired decision-making capabilities, legally authorized representatives may sign and give informed consent on behalf of study participants in accordance with applicable federal, local, and Central Institutional Review Board (CIRB) regulations
- As part of the registration process the treating institution's identity is provided in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered in the system
Who cannot join
- Participant must not have evidence of distant metastatic disease by conventional imaging within 90 days prior to registration
- NOTE: cN1 detected only by PSMA-PET is permitted if urologist deems sites of disease to be potentially completely resectable
- Participant must not have received prior radiation therapy (RT) to the pelvic region
- Participant must not have a prior or concurrent malignancy whose natural history or treatment (in the opinion of the treating physician) has the potential to interfere with the safety or efficacy assessment of protocol treatment
Trial locations and contacts
133 sites in 1 country. Contact the study team or a site near you to ask about taking part.
133 sites in 1 country
United States133 sites, 132 recruiting
- Recruiting
Providence Regional Cancer System-Aberdeen
Aberdeen, Washington, 98520
Site Public Contact, 360-412-8958, deidre.dillon@providence.org
Charles W. Drescher
- Recruiting
Community Hospital of Anaconda
Anaconda, Montana, 59711
Site Public Contact, 406-969-6060, mccinfo@mtcancer.org
John M. Schallenkamp
- Recruiting
Anchorage Associates in Radiation Medicine
Anchorage, Alaska, 98508
Site Public Contact, 907-212-6871, AKPAMC.OncologyResearchSupport@providence.org
Charles W. Drescher
- Recruiting
Anchorage Radiation Therapy Center
Anchorage, Alaska, 99504
Site Public Contact, 907-212-6871, AKPAMC.OncologyResearchSupport@providence.org
Charles W. Drescher
- Recruiting
Alaska Breast Care and Surgery LLC
Anchorage, Alaska, 99508
Site Public Contact, 907-212-6871, AKPAMC.OncologyResearchSupport@providence.org
Charles W. Drescher
- Recruiting
Alaska Oncology and Hematology LLC
Anchorage, Alaska, 99508
Site Public Contact, 907-212-6871, AKPAMC.OncologyResearchSupport@providence.org
Charles W. Drescher
- Recruiting
Alaska Women's Cancer Care
Anchorage, Alaska, 99508
Site Public Contact, 907-212-6871, AKPAMC.OncologyResearchSupport@providence.org
Charles W. Drescher
- Recruiting
Anchorage Oncology Centre
Anchorage, Alaska, 99508
Site Public Contact, 907-212-6871, AKPAMC.OncologyResearchSupport@providence.org
Charles W. Drescher
- Recruiting
Katmai Oncology Group
Anchorage, Alaska, 99508
Site Public Contact, 907-212-6871, AKPAMC.OncologyResearchSupport@providence.org
Charles W. Drescher
- Recruiting
Providence Alaska Medical Center
Anchorage, Alaska, 99508
Site Public Contact, 907-212-6871, AKPAMC.OncologyResearchSupport@providence.org
Charles W. Drescher
- Recruiting
Mission Hope Medical Oncology - Arroyo Grande
Arroyo Grande, California, 93420
Site Public Contact, 805-219-4673, ResearchInstituteInquiries@CommonSpirit.org
Shahzad Siddique
- Recruiting
Saint Alphonsus Medical Center-Baker City
Baker City, Oregon, 97814
Site Public Contact, 406-969-6060, mccinfo@mtcancer.org
John M. Schallenkamp
- Recruiting
Flaget Memorial Hospital
Bardstown, Kentucky, 40004
Site Public Contact, 859-629-7169, ResearchInstituteInquiries@CommonSpirit.org
Shahzad Siddique
- Recruiting
PeaceHealth Saint Joseph Medical Center
Bellingham, Washington, 98225
Site Public Contact, 360-788-8223
Charles W. Drescher
- Recruiting
Saint Charles Health System
Bend, Oregon, 97701
Site Public Contact, 541-706-2909, nosall@stcharleshealthcare.org
Charles W. Drescher
- Recruiting
Billings Clinic Cancer Center
Billings, Montana, 59101
Site Public Contact, 800-996-2663, research@billingsclinic.org
John M. Schallenkamp
- Recruiting
Saint Alphonsus Cancer Care Center-Boise
Boise, Idaho, 83706
Site Public Contact, 734-712-3671, stephanie.couch@stjoeshealth.org
John M. Schallenkamp
- Recruiting
Saint Luke's Cancer Institute - Boise
Boise, Idaho, 83712
Site Public Contact, 208-381-2774, eslinget@slhs.org
Charles W. Drescher
- Recruiting
Bozeman Deaconess Hospital
Bozeman, Montana, 59715
Site Public Contact, 406-969-6060, mccinfo@mtcancer.org
John M. Schallenkamp
- Recruiting
Harrison Medical Center
Bremerton, Washington, 98310
Site Public Contact, 253-426-6882, ResearchInstituteInquiries@CommonSpirit.org
Shahzad Siddique
- Recruiting
Providence Saint Joseph Medical Center/Disney Family Cancer Center
Burbank, California, 91505
Site Public Contact, 818-847-4793, Najee.Boucher@providence.org
Charles W. Drescher
- Recruiting
Saint Alphonsus Cancer Care Center-Caldwell
Caldwell, Idaho, 83605
Site Public Contact, 734-712-3671, stephanie.couch@stjoeshealth.org
John M. Schallenkamp
- Recruiting
Mercy Cancer Center �� Carmichael
Carmichael, California, 95608
Site Public Contact, protocols@swog.org
Shahzad Siddique
- Recruiting
Mercy San Juan Medical Center
Carmichael, California, 95608
Site Public Contact, 916-556-3301, OncologyResearch@DignityHealth.org
Shahzad Siddique
- Recruiting
Providence Regional Cancer System-Centralia
Centralia, Washington, 98531
Site Public Contact, 360-412-8958, deidre.dillon@providence.org
Charles W. Drescher
- Recruiting
Good Samaritan Hospital - Cincinnati
Cincinnati, Ohio, 45220
Site Public Contact, 513-853-1300, ResearchInstituteInquiries@CommonSpirit.org
Shahzad Siddique
- Recruiting
Bethesda North Hospital
Cincinnati, Ohio, 45242
Site Public Contact, 513-853-1300, ResearchInstituteInquiries@CommonSpirit.org
Shahzad Siddique
- Recruiting
TriHealth Cancer Institute-Westside
Cincinnati, Ohio, 45247
Site Public Contact, 513-853-1300, ResearchInstituteInquiries@CommonSpirit.org
Shahzad Siddique
- Recruiting
TriHealth Cancer Institute-Anderson
Cincinnati, Ohio, 45255
Site Public Contact, 513-853-1300, ResearchInstituteInquiries@CommonSpirit.org
Shahzad Siddique
- Recruiting
Clackamas Radiation Oncology Center
Clackamas, Oregon, 97015
Site Public Contact, 503-215-2614, CanRsrchStudies@providence.org
Charles W. Drescher
- Recruiting
Providence Cancer Institute Clackamas Clinic
Clackamas, Oregon, 97015
Site Public Contact, 503-215-2614, CanRsrchStudies@providence.org
Charles W. Drescher
- Recruiting
Billings Clinic-Cody
Cody, Wyoming, 82414
Site Public Contact, 800-996-2663, research@billingsclinic.org
John M. Schallenkamp
- 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, 719-776-6550, ResearchTracking@Centura.Org
Shahzad Siddique
- Recruiting
Rocky Mountain Cancer Centers-Penrose
Colorado Springs, Colorado, 80907
Site Public Contact, 719-776-6550, ResearchTracking@Centura.Org
Shahzad Siddique
- Recruiting
Saint Francis Cancer Center
Colorado Springs, Colorado, 80923
Site Public Contact, 719-776-6550, ResearchTracking@Centura.Org
Shahzad Siddique
- Recruiting
Bay Area Hospital
Coos Bay, Oregon, 97420
Site Public Contact, 541-269-8392, cherie.cox@bayareahospital.org
Charles W. Drescher
- Recruiting
Commonwealth Cancer Center-Corbin
Corbin, Kentucky, 40701
Site Public Contact, 859-629-7169, ResearchInstituteInquiries@CommonSpirit.org
Shahzad Siddique
- Recruiting
Alegent Health Mercy Hospital
Council Bluffs, Iowa, 51503
Site Public Contact, 402-717-1510, ResearchInstituteInquiries@CommonSpirit.org
Shahzad Siddique
- Recruiting
Porter Adventist Hospital
Denver, Colorado, 80210
Site Public Contact, 719-776-6550, ResearchTracking@Centura.Org
Shahzad Siddique
- Recruiting
Smilow Cancer Hospital-Derby Care Center
Derby, Connecticut, 06418
Site Public Contact, 203-785-5702, canceranswers@yale.edu
Joseph W. Kim
- Recruiting
City of Hope Comprehensive Cancer Center
Duarte, California, 91010
Site Public Contact, 800-826-4673, becomingapatient@coh.org
Wesley Yip
- Recruiting
Mercy Medical Center
Durango, Colorado, 81301
Site Public Contact, 719-776-6550, ResearchTracking@Centura.Org
Shahzad Siddique
- Recruiting
Southwest Oncology PC
Durango, Colorado, 81301
Site Public Contact, 719-776-6550, ResearchTracking@Centura.Org
Shahzad Siddique
- Recruiting
Swedish Cancer Institute-Edmonds
Edmonds, Washington, 98026
Site Public Contact, 206-215-3086, PCRC-NCORP@Swedish.org
Charles W. Drescher
- Recruiting
Mercy Cancer Center - Elk Grove
Elk Grove, California, 95758
Site Public Contact, 916-556-3301, OncologyResearch@DignityHealth.org
Shahzad Siddique
- Recruiting
Walter Knox Memorial Hospital
Emmett, Idaho, 83617
Site Public Contact, 734-712-3671, stephanie.couch@stjoeshealth.org
John M. Schallenkamp
- Recruiting
NorthShore University HealthSystem-Evanston Hospital
Evanston, Illinois, 60201
Site Public Contact, 847-570-2109
Nicklas R. Pfanzelter
- Recruiting
Providence Regional Cancer Partnership
Everett, Washington, 98201
Site Public Contact, 425-261-3529, marilyn.birchman@providence.org
Charles W. Drescher
- Recruiting
Smilow Cancer Hospital Care Center-Fairfield
Fairfield, Connecticut, 06824
Site Public Contact, 203-785-5702, canceranswers@yale.edu
Joseph W. Kim
- Recruiting
Saint Luke's Cancer Institute - Fruitland
Fruitland, Idaho, 83619
Site Public Contact, 208-381-2774, eslinget@slhs.org
Charles W. Drescher
- Recruiting
Smilow Cancer Hospital Care Center at Glastonbury
Glastonbury, Connecticut, 06033
Site Public Contact, 203-785-5702, canceranswers@yale.edu
Joseph W. Kim
- Recruiting
NorthShore University HealthSystem-Glenbrook Hospital
Glenview, Illinois, 60026
Site Public Contact, 847-570-2109
Nicklas R. Pfanzelter
- Recruiting
Benefis Healthcare- 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
Smilow Cancer Hospital Care Center at Greenwich
Greenwich, Connecticut, 06830
Site Public Contact, 203-785-5702, canceranswers@yale.edu
Joseph W. Kim
- Recruiting
Smilow Cancer Hospital Care Center - Guilford
Guilford, Connecticut, 06437
Site Public Contact, 203-785-5702, canceranswers@yale.edu
Joseph W. Kim
- Recruiting
Smilow Cancer Hospital Care Center at Saint Francis
Hartford, Connecticut, 06105
Site Public Contact, 203-785-5702, canceranswers@yale.edu
Joseph W. Kim
- Recruiting
NorthShore University HealthSystem-Highland Park Hospital
Highland Park, Illinois, 60035
Site Public Contact, 847-570-2109
Nicklas R. Pfanzelter
- Recruiting
City of Hope at Irvine Lennar
Irvine, California, 92618
Site Public Contact, 877-467-3411
Wesley Yip
- Recruiting
Swedish Cancer Institute-Issaquah
Issaquah, Washington, 98029
Site Public Contact, 206-215-3086, PCRC-NCORP@Swedish.org
Charles W. Drescher
- Recruiting
Kalispell Regional 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, 308-865-7963, ResearchInstituteInquiries@CommonSpirit.org
Shahzad Siddique
- Recruiting
Kadlec Clinic Hematology and Oncology
Kennewick, Washington, 99336
Site Public Contact, 509-783-4637, research@kadlecmed.org
Charles W. Drescher
- Recruiting
Providence Regional Cancer System-Lacey
Lacey, Washington, 98503
Site Public Contact, 360-412-8958, deidre.dillon@providence.org
Charles W. Drescher
- Recruiting
Saint Anthony Hospital
Lakewood, Colorado, 80228
Site Public Contact, 719-776-6550, ResearchTracking@Centura.Org
Shahzad Siddique
- Recruiting
Saint Joseph Hospital
Lexington, Kentucky, 40504
Site Public Contact, protocols@swog.org
Shahzad Siddique
- Recruiting
Saint Joseph Radiation Oncology Resource Center
Lexington, Kentucky, 40504
Site Public Contact, 859-629-7169, ResearchInstituteInquiries@CommonSpirit.org
Shahzad Siddique
- Recruiting
Saint Joseph Hospital East
Lexington, Kentucky, 40509
Site Public Contact, 859-629-7169, ResearchInstituteInquiries@CommonSpirit.org
Shahzad Siddique
- Recruiting
Saint Elizabeth Regional Medical Center
Lincoln, Nebraska, 68510
Site Public Contact, 855-313-2409, ResearchInstituteInquiries@CommonSpirit.org
Shahzad Siddique
- Recruiting
Littleton Adventist Hospital
Littleton, Colorado, 80122
Site Public Contact, 719-776-6550, ResearchTracking@Centura.Org
Shahzad Siddique
- Recruiting
Saint Joseph London
London, Kentucky, 40741
Site Public Contact, 859-629-7169, ResearchInstituteInquiries@CommonSpirit.org
Shahzad Siddique
- Recruiting
Longmont United Hospital
Longmont, Colorado, 80501
Site Public Contact, 719-776-6550, ResearchTracking@Centura.Org
Shahzad Siddique
- Recruiting
PeaceHealth Saint John Medical Center
Longview, Washington, 98632
Site Public Contact, 360-514-2016, kmakin-bond@peacehealth.org
Charles W. Drescher
- Recruiting
Idaho Urologic Institute-Meridian
Meridian, Idaho, 83642
Site Public Contact, 734-712-3671, stephanie.couch@stjoeshealth.org
John M. Schallenkamp
- Recruiting
Saint Luke's Cancer Institute - Meridian
Meridian, Idaho, 83642
Site Public Contact, 208-381-2774, eslinget@slhs.org
Charles W. Drescher
- Recruiting
LSU Healthcare Network / Metairie Multi-Specialty Clinic
Metairie, Louisiana, 70006
Site Public Contact, 504-210-3539, emede1@lsuhsc.edu
Scott E. Delacroix
- Recruiting
Garnet Health Medical Center
Middletown, New York, 10940
Site Public Contact, 845-333-1133, jgerlach@garnethealth.org
Jeffrey M. Stewart
- Recruiting
Saint Patrick Hospital - Community Hospital
Missoula, Montana, 59802
Site Public Contact, 406-327-3118, amy.hanneman@providence.org
Charles W. Drescher
- Suspended
Community Medical Hospital
Missoula, Montana, 59804
- Recruiting
Saint Joseph Mount Sterling
Mount Sterling, Kentucky, 40353
Site Public Contact, protocols@swog.org
Shahzad Siddique
- Recruiting
Saint Luke's Cancer Institute - Nampa
Nampa, Idaho, 83686
Site Public Contact, 208-381-2774, eslinget@slhs.org
Charles W. Drescher
- Recruiting
Saint Alphonsus Cancer Care Center-Nampa
Nampa, Idaho, 83687
Site Public Contact, 406-969-6060, mccinfo@mtcancer.org
John M. Schallenkamp
- Recruiting
Providence Queen of The Valley
Napa, California, 94558
Site Public Contact, 707-521-3830
Charles W. Drescher
- Recruiting
Smilow Cancer Center/Yale-New Haven Hospital
New Haven, Connecticut, 06510
Site Public Contact, 203-785-5702, canceranswers@yale.edu
Joseph W. Kim
- Recruiting
Yale University
New Haven, Connecticut, 06520
Site Public Contact, 203-785-5702, canceranswers@yale.edu
Joseph W. Kim
- Recruiting
Louisiana State University Health Science Center
New Orleans, Louisiana, 70112
Site Public Contact, 504-210-3539, emede1@lsuhsc.edu
Scott E. Delacroix
- Recruiting
Providence Newberg Medical Center
Newberg, Oregon, 97132
Site Public Contact, 503-215-2614, CanRsrchStudies@providence.org
Charles W. Drescher
- Recruiting
Yale-New Haven Hospital North Haven Medical Center
North Haven, Connecticut, 06473
Site Public Contact, 203-785-5702, canceranswers@yale.edu
Joseph W. Kim
- Recruiting
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104
Site Public Contact, 405-271-8777, ou-clinical-trials@ouhsc.edu
Kelly L. Stratton
- Recruiting
Alegent Health Immanuel Medical Center
Omaha, Nebraska, 68122
Site Public Contact, 402-717-1510, ResearchInstituteInquiries@CommonSpirit.org
Shahzad Siddique
- Recruiting
Alegent Health Bergan Mercy Medical Center
Omaha, Nebraska, 68124
Site Public Contact, 402-717-1510, ResearchInstituteInquiries@CommonSpirit.org
Shahzad Siddique
- Recruiting
Alegent Health Lakeside Hospital
Omaha, Nebraska, 68130
Site Public Contact, 402-717-1510, ResearchInstituteInquiries@CommonSpirit.org
Shahzad Siddique
- Recruiting
Creighton University Medical Center
Omaha, Nebraska, 68131
Site Public Contact, 402-717-1510, ResearchInstituteInquiries@CommonSpirit.org
Shahzad Siddique
- Recruiting
Saint Alphonsus Medical Center-Ontario
Ontario, Oregon, 97914
Site Public Contact, 406-969-6060, mccinfo@mtcancer.org
John M. Schallenkamp
- Recruiting
Providence Willamette Falls Medical Center
Oregon City, Oregon, 97045
Site Public Contact, 503-215-2614, CanRsrchStudies@providence.org
Charles W. Drescher
- Recruiting
Midlands Community Hospital
Papillion, Nebraska, 68046
Site Public Contact, 402-717-1510, ResearchInstituteInquiries@CommonSpirit.org
Shahzad Siddique
- Recruiting
Parker Adventist Hospital
Parker, Colorado, 80138
Site Public Contact, 719-776-6550, ResearchTracking@Centura.Org
Shahzad Siddique
- Recruiting
Cancer Center at Saint Joseph's
Phoenix, Arizona, 85004
Site Public Contact, 602-406-0777, Research-cancerinstitute@dignityhealth.org
Shahzad Siddique
- Recruiting
Providence Portland Medical Center
Portland, Oregon, 97213
Site Public Contact, 503-215-2614, CanRsrchStudies@providence.org
Charles W. Drescher
- Recruiting
Providence Saint Vincent Medical Center
Portland, Oregon, 97225
Site Public Contact, 503-215-2614, CanRsrchStudies@providence.org
Charles W. Drescher
- Recruiting
Oregon Health and Science University
Portland, Oregon, 97239
Site Public Contact, 503-494-1080, trials@ohsu.edu
Alexandra O. Sokolova
- Recruiting
Kootenai Clinic Cancer Services - Post Falls
Post Falls, Idaho, 83854
Site Public Contact, 406-969-6060, mccinfo@mtcancer.org
John M. Schallenkamp
- Recruiting
Saint Mary Corwin Medical Center
Pueblo, Colorado, 81004
Site Public Contact, 719-776-6550, ResearchTracking@Centura.Org
Shahzad Siddique
- Recruiting
Saint Charles Health System-Redmond
Redmond, Oregon, 97756
Site Public Contact, 541-706-2909
Charles W. Drescher
- Recruiting
Mercy Cancer Center - Rocklin
Rocklin, California, 95765
Site Public Contact, 916-556-3301, OncologyResearch@DignityHealth.org
Shahzad Siddique
- Recruiting
Mercy Cancer Center - Sacramento
Sacramento, California, 95816
Site Public Contact, 916-556-3301, OncologyResearch@DignityHealth.org
Shahzad Siddique
- Recruiting
Pacific Central Coast Health Center-San Luis Obispo
San Luis Obispo, California, 93401
Site Public Contact, 805-219-4673, ResearchInstituteInquiries@CommonSpirit.org
Shahzad Siddique
- Recruiting
Kootenai Cancer Clinic
Sandpoint, Idaho, 83864
Site Public Contact, 406-969-6060, mccinfo@mtcancer.org
John M. Schallenkamp
- Recruiting
Mission Hope Medical Oncology - Santa Maria
Santa Maria, California, 93444
Site Public Contact, 805-219-4673, ResearchInstituteInquiries@CommonSpirit.org
Shahzad Siddique
- Recruiting
Providence Medical Foundation - Santa Rosa
Santa Rosa, California, 95403
Site Public Contact, 707-521-3830
Charles W. Drescher
- Recruiting
Providence Santa Rosa Memorial Hospital
Santa Rosa, California, 95405
Site Public Contact, 707-521-3830
Charles W. Drescher
- Recruiting
Swedish Medical Center-Ballard Campus
Seattle, Washington, 98107
Site Public Contact, 206-215-3086, PCRC-NCORP@Swedish.org
Charles W. Drescher
- Recruiting
FHCC South Lake Union
Seattle, Washington, 98109
Site Public Contact, 800-804-8824
Heather H. Cheng
- Recruiting
Fred Hutchinson Cancer Research Center
Seattle, Washington, 98109
Site Public Contact, 800-804-8824
Heather H. Cheng
- Recruiting
Swedish Medical Center-Cherry Hill
Seattle, Washington, 98122-5711
Site Public Contact, 206-215-3086, PCRC-NCORP@Swedish.org
Charles W. Drescher
- Recruiting
Swedish Medical Center-First Hill
Seattle, Washington, 98122
Site Public Contact, 206-215-3086, PCRC-NCORP@Swedish.org
Charles W. Drescher
- Recruiting
University of Washington Medical Center - Montlake
Seattle, Washington, 98195
Site Public Contact, 800-804-8824
Heather H. Cheng
- Recruiting
PeaceHealth United General Medical Center
Sedro-Woolley, Washington, 98284
Site Public Contact, 360-788-8238, lkey@peacehealth.org
Charles W. Drescher
- Recruiting
Providence Regional Cancer System-Shelton
Shelton, Washington, 98584
Site Public Contact, 360-412-8958, deidre.dillon@providence.org
Charles W. Drescher
- Recruiting
Welch Cancer Center
Sheridan, Wyoming, 82801
Site Public Contact, 406-969-6060, mccinfo@mtcancer.org
John M. Schallenkamp
- Recruiting
North Shore Medical Center
Skokie, Illinois, 60076
Site Public Contact, 888-823-5923, ctsucontact@westat.com
Nicklas R. Pfanzelter
- Recruiting
Smilow Cancer Hospital Care Center at Long Ridge
Stamford, Connecticut, 06902
Site Public Contact, 203-785-5702, canceranswers@yale.edu
Joseph W. Kim
- Recruiting
Smilow Cancer Hospital-Torrington Care Center
Torrington, Connecticut, 06790
Site Public Contact, 203-785-5702, canceranswers@yale.edu
Joseph W. Kim
- Recruiting
Smilow Cancer Hospital Care Center-Trumbull
Trumbull, Connecticut, 06611
Site Public Contact, 203-785-5702, canceranswers@yale.edu
Joseph W. Kim
- Recruiting
Saint Luke's Cancer Institute - Twin Falls
Twin Falls, Idaho, 83301
Site Public Contact, 208-381-2774, eslinget@slhs.org
Charles W. Drescher
- Recruiting
PeaceHealth Southwest Medical Center
Vancouver, Washington, 98664
Site Public Contact, 360-514-3940, kmakin-bond@peacehealth.org
Charles W. Drescher
- Recruiting
Providence Saint Mary Regional Cancer Center
Walla Walla, Washington, 99362
Site Public Contact, 509-897-5993, Cheryl.Dodd@providence.org
Charles W. Drescher
- Recruiting
Smilow Cancer Hospital-Waterbury Care Center
Waterbury, Connecticut, 06708
Site Public Contact, 203-785-5702, canceranswers@yale.edu
Joseph W. Kim
- Recruiting
Smilow Cancer Hospital Care Center - Waterford
Waterford, Connecticut, 06385
Site Public Contact, 203-785-5702, canceranswers@yale.edu
Joseph W. Kim
- Recruiting
Smilow Cancer Hospital Care Center - Westerly
Westerly, Rhode Island, 02891
Site Public Contact, 203-785-5702, canceranswers@yale.edu
Joseph W. Kim
- Recruiting
Woodland Memorial Hospital
Woodland, California, 95695
Site Public Contact, 916-556-3301, OncologyResearch@DignityHealth.org
Shahzad Siddique
- Recruiting
Providence Regional Cancer System-Yelm
Yelm, Washington, 98597
Site Public Contact, 360-412-8958, deidre.dillon@providence.org
Charles W. Drescher
About this study
Official title: S2210 A Phase II Study of Neoadjuvant Carboplatin for Localized, High Risk Prostate Cancer With Germline BRCA1/2 Mutations
This phase II trial tests how well carboplatin before surgery works in treating patients with high-risk prostate cancer and an inherited BRCA1 or BRCA2 gene mutation. Carboplatin is in a class of medications known as platinum-containing compounds. It works in a way similar to the anticancer drug cisplatin, but may be better tolerated than cisplatin. Carboplatin works by killing, stopping, or slowing the growth of tumor cells. Giving carboplatin before surgery may shrink tumors in patients with high-risk prostate cancer with BRCA1 and BRCA2 gene mutations.
Read the detailed description
PRIMARY OBJECTIVE:
- To evaluate the pathologic complete response rate at prostatectomy in patients with localized high-risk prostate cancer with germline BRCA2 or BRCA1 mutations who are treated with neoadjuvant carboplatin by central review of source documents.
SECONDARY OBJECTIVES:
- To evaluate prostate specific antigen (PSA) progression-free survival post-prostatectomy over the duration of follow-up and specifically, at the 3-year landmark.
II. To evaluate metastases free survival and overall survival. III. To evaluate the frequency and severity of toxicities of neoadjuvant carboplatin followed by radical prostatectomy.
BANKING OBJECTIVE:
- To bank specimens for future correlative studies.
OUTLINE:
Patients receive carboplatin intravenously (IV) on study. Patients then undergo surgery on study. Patients who experience PSA progression after surgery undergo computed tomography (CT) or magnetic resonance imaging (MRI) of the abdomen and pelvis, CT of the chest or chest X-ray, or prostate-specific membrane antigen (PSMA)-positron emission tomography (PET) throughout the trial. Patients also undergo collection of blood samples throughout the trial.
- Conditions
- Prostate Adenocarcinoma, Stage IIIB Prostate Cancer AJCC v8, Stage IIIC Prostate Cancer AJCC v8
- Being tested
- Biospecimen Collection, Carboplatin, Chest Radiography, Computed Tomography, Magnetic Resonance Imaging
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biospecimen CollectionProcedure or surgery
Also called Biological Sample Collection, Biospecimen Collected, Specimen Collection
Undergo collection of blood samples
CarboplatinDrug
Also called Blastocarb, Carboplat, Carboplatin Hexal, Carboplatino
Given IV
Chest RadiographyProcedure or surgery
Also called Chest X-ray
Undergo chest X-ray
Computed TomographyProcedure or surgery
Also called CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography
Undergo CT
Magnetic Resonance ImagingProcedure or surgery
Also called Magnetic Resonance, Magnetic Resonance Imaging Scan, Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance, MR
Undergo MRI
PSMA PET ScanProcedure or surgery
Also called Prostate-specific Membrane Antigen PET, PSMA PET, PSMA-Positron emission tomography
Undergo PSMA PET
Surgical ProcedureProcedure or surgery
Also called Operation, Surgery, Surgery Type, Surgical
Undergo surgery
| Study group | Role | What they receive |
|---|---|---|
| Treatment (carboplatin) | Experimental | Patients receive carboplatin IV on study. Patients then undergo surgery on study. Patients who experience PSA progression after surgery undergo CT or MRI of the abdomen and pelvis, CT of the chest or chest X-ray, or PSMA-PET throughout the trial. Patients also undergo collection of blood samples throughout the trial. Receives: Procedure: Biospecimen Collection; Drug: Carboplatin; Procedure: Chest Radiography; Procedure: Computed Tomography; Procedure: Magnetic Resonance Imaging; Procedure: PSMA PET Scan; Procedure: Surgical Procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathologic complete response after neoadjuvant carboplatin
A two-stage design will be used.
Measured: Up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2023
- Study start1 Mar 2024
- Primary completionJul 2027 (estimated)
- Study completionJun 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate AdenocarcinomaStudies of the same condition, open and under way.
- More trials run by SWOG Cancer Research NetworkThe 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- SWOG Cancer Research Network
- Sponsor type
- Research network
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Heather H Cheng, Principal investigator, SWOG Cancer Research Network
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05806515
- Sponsor's protocol ID
- S2210
- Other IDs
- NCI-2023-02356, S2210, S2210, U10CA180888
- Status last verified
- Jan 2026
- First submitted
- 28 Mar 2023
- Last updated
- 29 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- S2210 A Phase II Study of Neoadjuvant Carboplatin for Localized, High Risk Prostate Cancer With Germline BRCA1/2 Mutations
- ClinicalTrials.gov ID
- NCT05806515
- Acronym / sponsor ID
- S2210
- Conditions
- Prostate Adenocarcinoma, Stage IIIB Prostate Cancer AJCC v8, Stage IIIC Prostate Cancer AJCC v8
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- SWOG Cancer Research NetworkResearch network
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Jun 2031 (estimated)
- First posted
- 10 Apr 2023 (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 II trial tests how well carboplatin before surgery works in treating patients with high-risk prostate cancer and an inherited BRCA1 or BRCA2 gene mutation. Carboplatin is in a class of medications known as platinum-containing compounds. It works in a way similar to the anticancer drug cisplatin, but may be better tolerated than cisplatin. Carboplatin works by killing, stopping, or slowing the growth of tumor cells. Giving carboplatin before surgery may shrink tumors in patients with high-risk prostate cancer with BRCA1 and BRCA2 gene mutations.
Detailed description
PRIMARY OBJECTIVE:
- To evaluate the pathologic complete response rate at prostatectomy in patients with localized high-risk prostate cancer with germline BRCA2 or BRCA1 mutations who are treated with neoadjuvant carboplatin by central review of source documents.
SECONDARY OBJECTIVES:
- To evaluate prostate specific antigen (PSA) progression-free survival post-prostatectomy over the duration of follow-up and specifically, at the 3-year landmark.
II. To evaluate metastases free survival and overall survival. III. To evaluate the frequency and severity of toxicities of neoadjuvant carboplatin followed by radical prostatectomy.
BANKING OBJECTIVE:
- To bank specimens for future correlative studies.
OUTLINE:
Patients receive carboplatin intravenously (IV) on study. Patients then undergo surgery on study. Patients who experience PSA progression after surgery undergo computed tomography (CT) or magnetic resonance imaging (MRI) of the abdomen and pelvis, CT of the chest or chest X-ray, or prostate-specific membrane antigen (PSMA)-positron emission tomography (PET) throughout the trial. Patients also undergo collection of blood samples throughout the trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment (carboplatin) | Experimental | Procedure: Biospecimen Collection, Drug: Carboplatin, Procedure: Chest Radiography, Procedure: Computed Tomography, Procedure: Magnetic Resonance Imaging, Procedure: PSMA PET Scan, Procedure: Surgical ProcedurePatients receive carboplatin IV on study. Patients then undergo surgery on study. Patients who experience PSA progression after surgery undergo CT or MRI of the abdomen and pelvis, CT of the chest or chest X-ray, or PSMA-PET throughout the trial. Patients also undergo collection of blood samples throughout the trial. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (26 listed)
- Participant must have histologic diagnosis of prostate adenocarcinoma
- Participant must have high or very high-risk disease defined by at least one of the following:
- Participant must have documented evidence of germline mutation (pathogenic/likely pathogenic variant) in BRCA2 or BRCA1 through testing in a Clinical Laboratory Improvement Act (CLIA)-certified lab
- Participant may have initiated gonadotrophin releasing hormone (gnRH) agonist, gnRH antagonist, oral anti-androgen (e.g. bicalutamide, nilutamide, flutamide), or other agent intended to treat prostate cancer prior to registration. The effectiveness of the current depot of such treatment must not extend beyond 1 month after study registration. Agents listed above cannot be started after participant registration
- Participant must be >= 18 years old
Key exclusion criteria (4 listed)
- Participant must not have evidence of distant metastatic disease by conventional imaging within 90 days prior to registration
- Participant must not have received prior radiation therapy (RT) to the pelvic region
- Participant must not have a prior or concurrent malignancy whose natural history or treatment (in the opinion of the treating physician) has the potential to interfere with the safety or efficacy assessment of protocol treatment
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 |
|---|---|---|
| Biospecimen CollectionAlso: Biological Sample Collection, Biospecimen Collected, Specimen CollectionUndergo collection of blood samples | Procedure or surgery | Treatment (carboplatin) |
| CarboplatinAlso: Blastocarb, Carboplat, Carboplatin Hexal, CarboplatinoGiven IV | Drug | Treatment (carboplatin) |
| Chest RadiographyAlso: Chest X-rayUndergo chest X-ray | Procedure or surgery | Treatment (carboplatin) |
| Computed TomographyAlso: CAT, CAT Scan, Computed Axial Tomography, Computerized Axial TomographyUndergo CT | Procedure or surgery | Treatment (carboplatin) |
| Magnetic Resonance ImagingAlso: Magnetic Resonance, Magnetic Resonance Imaging Scan, Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance, MRUndergo MRI | Procedure or surgery | Treatment (carboplatin) |
| PSMA PET ScanAlso: Prostate-specific Membrane Antigen PET, PSMA PET, PSMA-Positron emission tomographyUndergo PSMA PET | Procedure or surgery | Treatment (carboplatin) |
| Surgical ProcedureAlso: Operation, Surgery, Surgery Type, SurgicalUndergo surgery | Procedure or surgery | Treatment (carboplatin) |
Primary outcome
Pathologic complete response after neoadjuvant carboplatin
Time frame: Up to 5 years
A two-stage design will be used.
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 29 Jan 2026.
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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
Anchorage Radiation Therapy Center
Anchorage, United States
Alaska Breast Care and Surgery LLC
Anchorage, United States
Heather H Cheng principal investigator
SWOG Cancer Research Network
133 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Biospecimen Collection, Carboplatin and Chest Radiography in people with Prostate Adenocarcinoma and Stage IIIB Prostate Cancer AJCC v8, run by SWOG Cancer Research Network at 133 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 26 inclusion and 4 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 29 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 133 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Pathologic complete response after neoadjuvant carboplatin (time frame: Up to 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Jan 2026.