AzTrials
AzTrials

Castration-Resistant Prostate CarcinomaPhase 2PREDICTNCT06632977

Targeted Treatment for Metastatic Prostate Cancer, The PREDICT Trial

A Phase 2 study testing Genetic testing, Valemetostat Tosylate and Magnetic Resonance Imaging in people with Castration-Resistant Prostate Carcinoma and Stage IVB Prostate Cancer AJCC v8, run by Alliance for Clinical Trials in Oncology at 108 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

This phase II trial evaluates whether genetic testing in prostate cancer is helpful in deciding which study treatment patients are assigned. Patient cancer tissue samples are obtained from a previous surgery or biopsy procedure and tested for deoxyribonucleic acid (DNA) and ribonucleic acid (RNA) abnormalities or… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Genetic testing, Valemetostat Tosylate and Magnetic Resonance Imaging
Could I receive a placebo?
No, everyone receives an active treatment
How many people
474 participants
Where
108 sitesUnited States
Study dates
6 Feb 2025to 11 Oct 2034
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
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • PRE-REGISTRATION: Histological or cytological evidence of prostate cancer. Patients with variant histologies including neuroendocrine, small cell and sarcomatoid prostate cancer are allowed to enroll and these will not be used as selection criteria for individual arms. Central pathology review is not required.
  • PRE-REGISTRATION: Measurable disease and/or non-measurable metastatic disease per RECIST version 1.1.
  • PRE-REGISTRATION: Tissue procured within 12 months of pre-registration (metastatic disease preferred over primary tissue, though both are acceptable) available for submission per Section 6.2. For patients who have progressed on A032102 and are pre-registering again, repeat tissue procurement will not be mandated.
  • PRE-REGISTRATION: Molecular report available performed as part of standard of care testing via any Clinical Laboratory Improvement Act (CLIA)-certified next generation sequencing (NGS) assay. Patients may be assigned based on pre-determined qualifying molecular/DNA alterations as stated in Section 4.8 after receipt of local molecular testing by the A032102 molecular tumor board (MTB). Final determination of arm assignment will be determined by the MTB. For qualifying DNA alteration determined by the MTB, testing may be from tumor tissue collected at any time or circulating tumor DNA (ctDNA) within 12 months of pre-registration. If no qualifying DNA alteration is identified based on the CLIA-certified next generation sequencing assay and MTB review, Caris testing, should be performed for both DNA/RNA profiling. Arm assignment based RNA requires testing of tumor tissue collected within 12 months of pre-registration and MTB review.
  • PRE-REGISTRATION: Age ≥ 18 years.
  • REGISTRATION: Progressive mCRPC as defined: 1) castrate levels of serum testosterone \< 50 ng/dL AND one or more of the following criteria (choose all the apply):
Show all 77Show fewer
  • PSA progression, defined by at least 2 consecutive rising PSA values at a minimum of 1-week intervals with the most recent PSA value being 2.0 ng/mL or higher, if confirmed PSA rise is the only indication of progression. Patients who received an anti-androgen must have PSA progression after withdrawal of anti-androgen therapy.
  • Radiographic progression per RECIST 1.1 criteria for soft tissue lesions
  • Bone metastasis progression per Prostate Cancer Working Group 3 (PCWG3) criteria.
  • REGISTRATION: Patients selected to receive lutetium Lu 177 vipivotide tetraxetan treatment are required to have prostate-specific membrane antigen (PSMA) positive mCRPC as determined by investigator assessment. For reference, in the VISION trial this was defined as at least 1 PSMA+ metastatic lesion (defined as uptake greater than that of liver parenchyma in lesions of any size in any organ system) and no PSMA- lesions (defined as uptake equal to or lower than that of liver parenchyma in any lymph node with a short axis of at least 2.5 cm, in any solid organ lesion with a short axis of at least 1.0 cm, or in any bone lesion with a soft-tissue component of at least 1.0 cm in the short axis).
  • REGISTRATION: Prior treatment with androgen receptor signaling inhibitor (ARSI) in either the metastatic hormone sensitive setting or mCRPC is required. Prior taxane therapy in either metastatic hormone sensitive setting or mCRPC is mandated unless patient is taxane ineligible or the patient refuses taxane therapy. Prior lutetium LU177 vipivotide tetraxetan treatment is permitted but not mandated. Patients with known germline or somatic deleterious BRCA 1/2 mutations must have received a prior PARPi.
  • REGISTRATION: Resolved toxicities from previous anticancer therapy, defined as toxicities (other than alopecia) resolved to Common Terminology Criteria for Adverse Events (CTCAE) version 5.0, grade ≤ 1 or baseline. Note: Subjects may be enrolled with chronic, stable grade 2 toxicities (defined as no worsening to \> grade 2 for at least 3 months prior to registration and managed with standard of care treatment) that the investigator deems related to previous anticancer therapy, comprised of:
  • Chemotherapy-induced neuropathy
  • Fatigue
  • Residual toxicities from prior treatment: Grade 1 or grade 2 endocrinopathies which may include: Hypothyroidism/hyperthyroidism. type I diabetes, hyperglycemia, adrenal insufficiency, adrenalitis, skin hypopigmentation (vitiligo)
  • REGISTRATION: No cytotoxic, biologic, radiopharmaceutical or other non-kinase inhibitor investigational agent within 4 weeks of registration. Treatment with any type of small molecular kinase inhibitor (including investigational kinase inhibitor) within 2 weeks of registration. Treatment with abiraterone acetate, apalutamide, or darolutamide within 2 weeks of registration. Treatment with enzalutamide within 4 weeks of registration. No treatment with radiation therapy within 2 weeks of registration.
  • REGISTRATION: No major surgery within 4 weeks of registration.
  • REGISTRATION: No prior treatment with EZH inhibitors.
  • REGISTRATION: Prior treatment with cabazitaxel + carboplatin.
  • REGISTRATION: None of the following conditions:
  • Current use of moderate or strong cytochrome P450 (CYP)3A inducers.
  • Known or suspected hypersensitivity to valemetostat tosylate (DS-3201b) or any of the excipients.
  • For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated. Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load.
  • HIV-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial.
  • Imminent or established spinal cord compression based on clinical and/or imaging findings.
  • Known brain metastases or cranial epidural disease unless adequately treated with radiotherapy and/or surgery (including radiosurgery) and stable for at least 4 weeks prior to registration after radiotherapy or at least 4 weeks prior to registration after major surgery (e.g., removal or biopsy of brain metastasis). Patients must have complete wound healing from major surgery or minor surgery before registration.
  • Significant cardiovascular defined as:
  • Myocardial infarction within 6 months prior to enrollment.
  • Uncontrolled angina pectoris within 6 months prior to enrollment.
  • New York Heart Association Class 3 or 4 congestive heart failure.
  • Corrected QT interval calculated by the Fridericia\'s formula (QTcF) ≥ 470 ms per electrocardiogram (ECG) within 42 days before randomization in any individual with any history of any cardiac disease or medication which can impact QTcF. Patients with known history or current symptoms of cardiac disease, history of treatment with cardiotoxic agents, or agents/conditions known to impact QTcF should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification and ECG.
  • Uncontrolled hypertension (resting systolic blood pressure \>160 mmHg or diastolic blood pressure \> 100 mmHg).
  • Clinically significant acute infection requiring systemic antibacterial, antifungal or antiviral therapy.
  • Moderate to severe hepatic impairment (Child-Pugh Class C)
  • REGISTRATION: No freezing or donating sperm ≤ 14 days prior to registration.
  • REGISTRATION: Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
  • REGISTRATION: No granulocyte colony-stimulating factor (GCSF) within 2 weeks of registration.
  • REGISTRATION: No red blood cell (RBC) transfusions within 2 weeks of registration.
  • REGISTRATION: No platelet transfusions within 2 weeks of registration.
  • REGISTRATION: No bleeding diathesis.
  • REGISTRATION: White blood cell count (WBC) ≥ 2,500/mcL.
  • REGISTRATION: Absolute neutrophil count (ANC) ≥ 1,500/mcL.
  • REGISTRATION: Hemoglobin ≥ 9 g/dL.
  • REGISTRATION: Platelet count ≥ 100,000/mcL.
  • REGISTRATION: Creatinine clearance ≥ 30 mL/min as defined by Cockcroft-Gault equation.
  • REGISTRATION: Total bilirubin ≤ 1.5 x ULN (≤ 3 x upper limit of normal [ULN] for subjects with documented Gilbert\'s disease).
  • REGISTRATION: Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 x ULN.
  • REGISTRATION: Albumin ≥ 2.8 g/dL.
  • REGISTRATION: The A032102 molecular tumor board will review the local pathology report and molecular sequencing report, and the Alliance registration/randomization office will relay the assignment to the submitting site. Once the site receives this assignment, they can register the patient to A032102. Any questions about the molecular board treatment assignments can be directed to A032102@alliancenctn.org.
  • RE-REGISTRATION: Progressive mCRPC (after receiving the tumor board assigned therapy) as defined: 1) castrate levels of serum testosterone \< 50 ng/dL AND 2) progressive disease defined by radiographic progression on conventional imaging (CT/MRI chest, abdomen and pelvis and bone scan within 42 days of re-registration).
  • RE-REGISTRATION: Resolved toxicities from previous anticancer therapy, defined as toxicities (other than alopecia) resolved to CTCAE version 5.0, grade ≤ 1 or baseline. Note: Subjects may be enrolled with chronic, stable grade 2 toxicities (defined as no worsening to \> grade 2 for at least 3 months prior to registration and managed with standard of care treatment) that the investigator deems related to previous anticancer therapy, comprised of:
  • Chemotherapy-induced neuropathy
  • Fatigue
  • Residual toxicities from prior treatment: Grade 1 or grade 2 endocrinopathies which may include: Hypothyroidism/hyperthyroidism. type I diabetes, hyperglycemia, adrenal insufficiency, adrenalitis, skin hypopigmentation (vitiligo).
  • RE-REGISTRATION: None of the following conditions:
  • Imminent or established spinal cord compression based on clinical and/or imaging findings.
  • Known brain metastases or cranial epidural disease unless adequately treated with radiotherapy and/or surgery (including radiosurgery) and stable for at least 4 weeks prior to registration after radiotherapy or at least 4 weeks prior to re-registration after major surgery (e.g., removal or biopsy of brain metastasis). Patients must have complete wound healing from major surgery or minor surgery before re-registration.
  • Corrected QT interval calculated by the Fridericia\'s formula (QTcF) \< 470 ms per ECG within 42 days before randomization in any individual with any history of any cardiac disease or medication which can impact QTcF.
  • Significant cardiovascular defined as:
  • Myocardial infarction within 6 months prior to enrollment.
  • Uncontrolled angina pectoris within 6 months prior to enrollment.
  • New York Heart Association Class 3 or 4 congestive heart failure.
  • Uncontrolled hypertension (resting systolic blood pressure \> 160 mmHg or diastolic blood pressure \> 100 mmHg).
  • RE-REGISTRATION: ECOG Performance Status 0-2.
  • RE-REGISTRATION: No GCSF within 2 weeks of registration.
  • RE-REGISTRATION: No RBC transfusions within 2 weeks of registration.
  • RE-REGISTRATION: No platelet transfusions within 2 weeks of registration.
  • RE-REGISTRATION: WBC ≥ 2,500/mcL.
  • RE-REGISTRATION: ANC ≥ 1,500/mcL.
  • RE-REGISTRATION: Hemoglobin ≥ 9 g/dL (transfusions permitted).
  • RE-REGISTRATION: Platelet count ≥ 100,000/mcL.
  • RE-REGISTRATION: Creatinine clearance ≥ 30 mL/min as defined by Cockcroft-Gault equation.
  • RE-REGISTRATION: Total bilirubin ≤ 1.5 x ULN (≤ 3 x ULN for subjects with documented Gilbert\'s disease).
  • RE-REGISTRATION: AST and ALT ≤ 3 x ULN.
  • RE-REGISTRATION: Albumin ≥ 2.8 g/dL.
  • RE-REGISTRATION: QT Interval (QTcF) \< 470 ms (in individuals with any cardiac history of any medication or condition known to impact QTcF).
  • RE-REGISTRATION: The A032102 molecular tumor board will review the CARIS molecular sequencing report, the Alliance registration/randomization office will relay the assignment to the site. Any questions about the molecular board treatment assignments can be directed to A032102@alliancenctn.org.

Who cannot join

  • -

Trial locations and contacts

108 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Rana McKay, MD contact

858-822-6185

rmckay@health.ucsd.edu

Shiva Baghaie contact

GUprotocols@alliancenctn.org

108 sites in 1 country

United States108 sites, 98 recruiting

  • McFarland Clinic - Ames

    Ames, Iowa, 50010

    Site Public Contact, 515-239-4734, ksoder@mcfarlandclinic.com

    Joseph J. Merchant

    Recruiting

  • University of Iowa Healthcare Cancer Services Quad Cities

    Bettendorf, Iowa, 52722

    Site Public Contact, 563-355-7733, katherine-daprile@uiowa.edu

    Fernando Maciel Barbosa

    Recruiting

  • Billings Clinic Cancer Center

    Billings, Montana, 59101

    Site Public Contact, 800-996-2663, research@billingsclinic.org

    John M. Schallenkamp

    Recruiting

  • University of Alabama at Birmingham Cancer Center

    Birmingham, Alabama, 35233

    Site Public Contact, gingerreeves@uabmc.edu

    Joelle Hamilton

    Recruiting

  • Illinois CancerCare-Bloomington

    Bloomington, Illinois, 61704

    Site Public Contact, 309-243-3605, andersonj@illinoiscancercare.com

    Bryan A. Faller

    Recruiting

  • Dana-Farber Cancer Institute

    Boston, Massachusetts, 02215

    Suspended

  • Essentia Health Saint Joseph's Medical Center

    Brainerd, Minnesota, 56401

    Site Public Contact, 218-786-3308, CancerTrials@EssentiaHealth.org

    Bret E. Friday

    Recruiting

  • Trinity Health IHA Medical Group Hematology Oncology - Brighton

    Brighton, Michigan, 48114

    Site Public Contact, 734-712-7251, MCRCwebsitecontactform@stjoeshealth.org

    Elie G. Dib

    Recruiting

  • Roswell Park Cancer Institute

    Buffalo, New York, 14263

    Site Public Contact, 800-767-9355, askroswell@roswellpark.org

    Ellis G. Levine

    Recruiting

  • Illinois CancerCare-Canton

    Canton, Illinois, 61520

    Site Public Contact, 309-243-3605, andersonj@illinoiscancercare.com

    Bryan A. Faller

    Recruiting

  • Trinity Health IHA Medical Group Hematology Oncology - Canton

    Canton, Michigan, 48188

    Site Public Contact, 734-712-7251, MCRCwebsitecontactform@stjoeshealth.org

    Elie G. Dib

    Recruiting

  • UNC Lineberger Comprehensive Cancer Center

    Chapel Hill, North Carolina, 27599

    Site Public Contact, 877-668-0683, cancerclinicaltrials@med.unc.edu

    Catherine Fahey

    Recruiting

  • Vandalia Health/CAMC Institute for Academic Medicine

    Charleston, West Virginia, 25304

    Active, not recruiting

  • Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital

    Chelsea, Michigan, 48118

    Site Public Contact, 734-712-7251, MCRCwebsitecontactform@stjoeshealth.org

    Elie G. Dib

    Recruiting

  • Enloe Medical Center

    Chico, California, 95926

    Site Public Contact, 530-332-4700

    Nicholas Mitsiades

    Recruiting

  • Siteman Cancer Center at Saint Peters Hospital

    City of Saint Peters, Missouri, 63376

    Site Public Contact, 800-600-3606, info@siteman.wustl.edu

    Eric M. Knoche

    Recruiting

  • MetroHealth Medical Center

    Cleveland, Ohio, 44109

    Site Public Contact, 216-778-7559, ababal@metrohealth.org

    Joseph Attallah

    Recruiting

  • Kootenai Health - Coeur d'Alene

    Coeur d'Alene, Idaho, 83814

    Suspended

  • UCHealth Memorial Hospital Central

    Colorado Springs, Colorado, 80909

    Site Public Contact, 719-365-2406

    Steven R. Schuster

    Recruiting

  • Memorial Hospital North

    Colorado Springs, Colorado, 80920

    Site Public Contact, 719-364-6700

    Steven R. Schuster

    Recruiting

  • MU Health - University Hospital/Ellis Fischel Cancer Center

    Columbia, Missouri, 65212

    Active, not recruiting

  • Ohio State University Comprehensive Cancer Center

    Columbus, Ohio, 43210

    Site Public Contact, 800-293-5066, Jamesline@osumc.edu

    Timothy D. Gauntner

    Recruiting

  • Siteman Cancer Center at West County Hospital

    Creve Coeur, Missouri, 63141

    Site Public Contact, 800-600-3606, info@siteman.wustl.edu

    Eric M. Knoche

    Recruiting

  • Parkland Memorial Hospital

    Dallas, Texas, 75235

    Suspended

  • UT Southwestern Simmons Cancer Center - RedBird

    Dallas, Texas, 75237

    Site Public Contact, 214-648-7097, canceranswerline@utsouthwestern.edu

    Joseph Vento

    Recruiting

  • UT Southwestern/Simmons Cancer Center-Dallas

    Dallas, Texas, 75390

    Site Public Contact, 214-648-7097, canceranswerline@UTSouthwestern.edu

    Joseph Vento

    Recruiting

  • Carle at The Riverfront

    Danville, Illinois, 61832

    Site Public Contact, 800-446-5532, Research@Carle.com

    Priyank P. Patel

    Recruiting

  • Essentia Health Cancer Center

    Duluth, Minnesota, 55805

    Site Public Contact, 218-786-3308, CancerTrials@EssentiaHealth.org

    Bret E. Friday

    Recruiting

  • Saint Elizabeth Healthcare Edgewood

    Edgewood, Kentucky, 41017

    Site Public Contact, 859-301-4730, Kristi.Curtsinger@stelizabeth.com

    Matthew Kurian

    Recruiting

  • Swedish Cancer Institute-Edmonds

    Edmonds, Washington, 98026

    Site Public Contact, 206-215-2343, PCRC-NCORP@Swedish.org

    Alison K. Conlin

    Recruiting

  • Carle Physician Group-Effingham

    Effingham, Illinois, 62401

    Site Public Contact, 800-446-5532, Research@carle.com

    Priyank P. Patel

    Recruiting

  • UC San Diego Health System - Encinitas

    Encinitas, California, 92024

    Site Public Contact, 760-536-7700

    Rana R. McKay

    Recruiting

  • Illinois CancerCare-Eureka

    Eureka, Illinois, 61530

    Site Public Contact, 309-243-3605, andersonj@illinoiscancercare.com

    Bryan A. Faller

    Recruiting

  • Essentia Health Cancer Center-South University Clinic

    Fargo, North Dakota, 58103

    Site Public Contact, 218-786-3308, CancerTrials@EssentiaHealth.org

    Bret E. Friday

    Recruiting

  • Poudre Valley Hospital

    Fort Collins, Colorado, 80524

    Site Public Contact, 970-297-6150

    Steven R. Schuster

    Recruiting

  • Cancer Care and Hematology-Fort Collins

    Fort Collins, Colorado, 80528

    Site Public Contact, 773-702-9171, protocols@AllianceNCTN.org

    Steven R. Schuster

    Recruiting

  • Saint Elizabeth Healthcare Fort Thomas

    Fort Thomas, Kentucky, 41075

    Suspended

  • UT Southwestern/Simmons Cancer Center-Fort Worth

    Fort Worth, Texas, 76104

    Site Public Contact, 214-648-7097, canceranswerline@UTSouthwestern.edu

    Joseph Vento

    Recruiting

  • Dana-Farber Cancer Institute at Foxborough

    Foxborough, Massachusetts, 02035

    Site Public Contact, 877-338-7425

    Daniel Roberts

    Recruiting

  • Gibbs Cancer Center-Gaffney

    Gaffney, South Carolina, 29341

    Site Public Contact, 864-560-6104, kmertz-rivera@gibbscc.org

    Michael Humeniuk

    Recruiting

  • UCHealth Greeley Hospital

    Greeley, Colorado, 80631

    Site Public Contact, 773-702-9171, protocols@AllianceNCTN.org

    Steven R. Schuster

    Recruiting

  • Gibbs Cancer Center-Pelham

    Greer, South Carolina, 29651

    Site Public Contact, 864-560-6104, kmertz-rivera@gibbscc.org

    Michael Humeniuk

    Recruiting

  • Hackensack University Medical Center

    Hackensack, New Jersey, 07601

    Site Public Contact, 551-996-2897

    Robert S. Alter

    Recruiting

  • Tripler Army Medical Center

    Honolulu, Hawaii, 96859

    Site Public Contact, 808-433-6336

    Karen J. Shou

    Recruiting

  • Edwards Comprehensive Cancer Center

    Huntington, West Virginia, 25701

    Site Public Contact, 304-399-6566, Christina.Cole@chhi.org

    Toni O. Pacioles

    Recruiting

  • University of Iowa/Holden Comprehensive Cancer Center

    Iowa City, Iowa, 52242

    Site Public Contact, 800-237-1225

    Fernando Maciel Barbosa

    Recruiting

  • UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care

    Irvine, California, 92612

    Active, not recruiting

  • Jupiter Medical Center

    Jupiter, Florida, 33458

    Site Public Contact, 561-263-5791, clinicaltrials@jupitermed.com

    Ryan H. Devine

    Recruiting

  • University of Kansas Cancer Center

    Kansas City, Kansas, 66160

    Site Public Contact, 913-588-3671, KUCC_Navigation@kumc.edu

    Elizabeth M. Wulff

    Recruiting

  • UC San Diego Moores Cancer Center

    La Jolla, California, 92093

    Site Public Contact, 858-822-5354, cancercto@ucsd.edu

    Rana R. McKay

    Recruiting

  • University of Michigan Health - Sparrow Lansing

    Lansing, Michigan, 48912

    Site Public Contact, 517-364-3712, harsha.trivedi@umhsparrow.org

    Elie G. Dib

    Recruiting

  • Trinity Health Saint Mary Mercy Livonia Hospital

    Livonia, Michigan, 48154

    Site Public Contact, 734-712-7251, MCRCwebsitecontactform@stjoeshealth.org

    Elie G. Dib

    Recruiting

  • Medical Center of the Rockies

    Loveland, Colorado, 80538

    Site Public Contact, 970-203-7083

    Steven R. Schuster

    Recruiting

  • Marshfield Medical Center-Marshfield

    Marshfield, Wisconsin, 54449

    Site Public Contact, 800-782-8581, oncology.clinical.trials@marshfieldresearch.org

    Michael Husak

    Recruiting

  • Carle Physician Group-Mattoon/Charleston

    Mattoon, Illinois, 61938

    Site Public Contact, 800-446-5532, Research@carle.com

    Priyank P. Patel

    Recruiting

  • Bon Secours Memorial Regional Medical Center

    Mechanicsville, Virginia, 23116

    Site Public Contact, 804-893-8978, anne_carmellat@bshsi.org

    Joseph D. Pennington

    Recruiting

  • Froedtert Menomonee Falls Hospital

    Menomonee Falls, Wisconsin, 53051

    Site Public Contact, 262-257-5100

    Kathryn A. Bylow

    Recruiting

  • Dana Farber-Merrimack Valley

    Methuen, Massachusetts, 01844

    Site Public Contact, 877-338-7425

    Pedro M. Sanz-Altamira

    Recruiting

  • Bon Secours Saint Francis Medical Center

    Midlothian, Virginia, 23114

    Site Public Contact, 804-893-8978, anne_carmellat@bshsi.org

    Joseph D. Pennington

    Recruiting

  • Dana-Farber/Brigham and Women's Cancer Center at Milford Regional

    Milford, Massachusetts, 01757

    Site Public Contact, 877-332-4294

    Daniel E. Fein

    Recruiting

  • Beebe South Coastal Health Campus

    Millville, Delaware, 19967

    Site Public Contact, 302-291-6730, research@beebehealthcare.org

    Gregory A. Masters

    Recruiting

  • Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226

    Site Public Contact, 414-805-3666

    Kathryn A. Bylow

    Recruiting

  • Vanderbilt University/Ingram Cancer Center

    Nashville, Tennessee, 37232

    Suspended

  • Mount Sinai Hospital

    New York, New York, 10029

    Site Public Contact, 212-824-7309, CCTO@mssm.edu

    Eric J. Miller

    Recruiting

  • Helen F Graham Cancer Center

    Newark, Delaware, 19713

    Site Public Contact, 302-623-4450, lbarone@christianacare.org

    Gregory A. Masters

    Recruiting

  • Medical Oncology Hematology Consultants PA

    Newark, Delaware, 19713

    Site Public Contact, 302-623-4450, lbarone@christianacare.org

    Gregory A. Masters

    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

  • Drexel Town Square Health Center

    Oak Creek, Wisconsin, 53154

    Site Public Contact, 414-805-0505

    Kathryn A. Bylow

    Recruiting

  • University of Oklahoma Health Sciences Center

    Oklahoma City, Oklahoma, 73104

    Site Public Contact, 405-271-8777, ou-clinical-trials@ouhsc.edu

    Adanma Anji Ayanambakkam Attanathi

    Recruiting

  • The University of Kansas Cancer Center - Olathe

    Olathe, Kansas, 66061

    Site Public Contact, 913-588-1569, OlatheCCResearch@kumc.edu

    Elizabeth M. Wulff

    Recruiting

  • UC Irvine Health/Chao Family Comprehensive Cancer Center

    Orange, California, 92868

    Active, not recruiting

  • Illinois CancerCare-Ottawa Clinic

    Ottawa, Illinois, 61350

    Site Public Contact, 309-243-3605, andersonj@illinoiscancercare.com

    Bryan A. Faller

    Recruiting

  • University of Kansas Hospital-Indian Creek Campus

    Overland Park, Kansas, 66211

    Site Public Contact, 913-588-3671, KUCC_Navigation@kumc.edu

    Elizabeth M. Wulff

    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

  • Illinois CancerCare-Peru

    Peru, Illinois, 61354

    Site Public Contact, 309-243-3605, andersonj@illinoiscancercare.com

    Bryan A. Faller

    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

    Alexandra O. Sokolova

    Recruiting

  • Beebe Health Campus

    Rehoboth Beach, Delaware, 19971

    Site Public Contact, 302-291-6730, research@beebehealthcare.org

    Gregory A. Masters

    Recruiting

  • UT Southwestern Clinical Center at Richardson/Plano

    Richardson, Texas, 75080

    Site Public Contact, 972-669-7044, Suzanne.cole@utsouthwestern.edu

    Joseph Vento

    Recruiting

  • Bon Secours Richmond Community Hospital

    Richmond, Virginia, 23223

    Site Public Contact, 804-893-8978, anne_carmellat@bshsi.org

    Joseph D. Pennington

    Recruiting

  • Bon Secours Saint Mary's Hospital

    Richmond, Virginia, 23226

    Site Public Contact, 804-893-8978, anne_carmellat@bshsi.org

    Joseph D. Pennington

    Recruiting

  • Bon Secours Cancer Institute at Reynolds Crossing

    Richmond, Virginia, 23230

    Site Public Contact, 804-893-8978, Anne_caramella@bshsi.org

    Joseph D. Pennington

    Recruiting

  • VCU Massey Cancer Center at Stony Point

    Richmond, Virginia, 23235

    Site Public Contact, ctoclinops@vcu.edu

    John Melson

    Recruiting

  • VCU Massey Comprehensive Cancer Center

    Richmond, Virginia, 23298

    Site Public Contact, 804-628-6430, CTOclinops@vcu.edu

    John Melson

    Recruiting

  • University of California Davis Comprehensive Cancer Center

    Sacramento, California, 95817

    Site Public Contact, 916-734-3089

    Nicholas Mitsiades

    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

  • UC San Diego Medical Center - Hillcrest

    San Diego, California, 92103

    Site Public Contact, rhabbaba@health.ucsd.edu

    Rana R. McKay

    Recruiting

  • Guthrie Medical Group PC-Robert Packer Hospital

    Sayre, Pennsylvania, 18840

    Active, not recruiting

  • Swedish Medical Center-First Hill

    Seattle, Washington, 98122

    Site Public Contact, 206-215-2343, PCRC-NCORP@Swedish.org

    Alison K. Conlin

    Recruiting

  • Memorial Hospital East

    Shiloh, Illinois, 62269

    Site Public Contact, 314-747-9912, dschwab@wustl.edu

    Eric M. Knoche

    Recruiting

  • Dana-Farber/Brigham and Women's Cancer Center at South Shore

    South Weymouth, Massachusetts, 02190

    Site Public Contact, 781-624-5000

    Thomas P. O'Connor

    Recruiting

  • Spartanburg Medical Center

    Spartanburg, South Carolina, 29303

    Site Public Contact, 864-560-6104, kmertz-rivera@gibbscc.org

    Michael Humeniuk

    Recruiting

  • Baystate Medical Center

    Springfield, Massachusetts, 01199

    Site Public Contact, 413-794-3565, tamara.wrenn@baystatehealth.org

    John C. McCann

    Recruiting

  • Washington University School of Medicine

    St Louis, Missouri, 63110

    Site Public Contact, 800-600-3606, info@siteman.wustl.edu

    Eric M. Knoche

    Recruiting

  • Siteman Cancer Center-South County

    St Louis, Missouri, 63129

    Site Public Contact, 800-600-3606, info@siteman.wustl.edu

    Eric M. Knoche

    Recruiting

  • Siteman Cancer Center at Christian Hospital

    St Louis, Missouri, 63136

    Site Public Contact, 800-600-3606, info@siteman.wustl.edu

    Eric M. Knoche

    Recruiting

  • Stamford Hospital/Bennett Cancer Center

    Stamford, Connecticut, 06904

    Site Public Contact, 203-323-8944

    Anthony P. Gulati

    Recruiting

  • University of Kansas Health System Saint Francis Campus

    Topeka, Kansas, 66606

    Site Public Contact, 785-295-8000

    Elizabeth M. Wulff

    Recruiting

  • Banner University Medical Center - Tucson

    Tucson, Arizona, 85719

    Site Public Contact, UACC-IIT@uacc.arizona.edu

    Edward P. Gelmann

    Recruiting

  • University of Arizona Cancer Center-North Campus

    Tucson, Arizona, 85719

    Site Public Contact, UACC-IIT@uacc.arizona.edu

    Edward P. Gelmann

    Recruiting

  • SMC Center for Hematology Oncology Union

    Union, South Carolina, 29379

    Site Public Contact, 864-560-6104, kmertz-rivera@gibbscc.org

    Michael Humeniuk

    Recruiting

  • Carle Cancer Center

    Urbana, Illinois, 61801

    Site Public Contact, 800-446-5532, Research@carle.com

    Priyank P. Patel

    Recruiting

  • Illinois CancerCare - Washington

    Washington, Illinois, 61571

    Site Public Contact, 309-243-3605, andersonj@illinoiscancercare.com

    Bryan A. Faller

    Recruiting

  • Froedtert West Bend Hospital/Kraemer Cancer Center

    West Bend, Wisconsin, 53095

    Site Public Contact, 414-805-0505

    Kathryn A. Bylow

    Recruiting

  • University of Kansas Hospital-Westwood Cancer Center

    Westwood, Kansas, 66205

    Site Public Contact, 913-588-3671, KUCC_Navigation@kumc.edu

    Elizabeth M. Wulff

    Recruiting

  • Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus

    Ypsilanti, Michigan, 48197

    Site Public Contact, 734-712-7251, MCRCwebsitecontactform@stjoeshealth.org

    Elie G. Dib

    Recruiting

Other trials in United States

About this study

Official title: PREcision DIagnostics in Prostate Cancer Treatment (PREDICT)

This phase II trial evaluates whether genetic testing in prostate cancer is helpful in deciding which study treatment patients are assigned. Patient cancer tissue samples are obtained from a previous surgery or biopsy procedure and tested for deoxyribonucleic acid (DNA) and ribonucleic acid (RNA) abnormalities or mutations in their cancer. Valemetostat tosylate is in a class of medications called EZH1/EZH2 inhibitors. It blocks proteins called EZH1 and EZH2, which may help slow or stop the spread of tumor cells. 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. Cabazitaxel injection is in a class of medications called microtubule inhibitors. It works by slowing or stopping the growth of tumor cells. Abiraterone acetate blocks tissues from making androgens (male hormones), such as testosterone. This may cause the death of tumor cells that need androgens to grow. It is a type of anti-androgen. Enzalutamide is in a class of medications called androgen receptor inhibitors. It works by blocking the effects of androgen (a male reproductive hormone) to stop the growth and spread of tumor cells. Lutetium Lu 177 vipivotide tetraxetan is in a class of medications called radiopharmaceuticals. It works by targeting and delivering radiation directly to tumor cells which damages and kills these cells. Assigning patients to targeted treatment based on genetic testing may help shrink or slow the cancer from growing

Read the detailed description

The primary and secondary objectives of the study:

PRIMARY OBJECTIVE:

  1. Evaluate objective response rate in patients with measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 for measurable disease, in each treatment arm.

SECONDARY OBJECITVES:

  1. To determine safety and tolerability as determined by Common Terminology Criteria in Adverse Events (CTCAE) version 5.0 in each treatment arm.

II. To evaluate 9-month radiographic progression free survival in each arm as defined by Prostate Cancer Clinical Trials Working Group 3 (PCWG-3) for patients with bone metastases and RECIST version 1.1 for patients with measurable disease.

III. To evaluate radiographic progression free survival in each arm as defined by PCWG-3 for patients with bone metastases and RECIST version 1.1 for patients with measurable disease.

IV. To evaluate prostate-specific antigen (PSA) response defined as ≥ 50% decline in PSA from baseline using PCWG-3 criteria in patients in each treatment arm.

  1. To evaluate time to PSA progression as defined by PCWG-3 criteria in patients in each treatment arm.

VI. To evaluate time to occurrence of first symptomatic skeletal event. VII. To evaluate time to first subsequent anti-cancer therapy (including androgen receptor signaling agents, cytotoxic chemotherapy, immunotherapy, or investigational agents) or death.

VIII. To evaluate overall survival, defined as time from registration to death due to any cause censored at the date of last follow-up, in each treatment arm.

IX. To evaluate patient-reported outcomes (PRO) via Patient-Reported Outcomes (PRO)-CTCAE in each treatment arm.

  1. To evaluate duration of response as defined by RECIST version 1.1 for patients with measurable disease.

CORRELATIVE OBJECTIVES:

  1. Correlate presence of molecular abnormalities with baseline clinical characteristics.

II. Evaluate co-occurring molecular alterations within each biomarker arm. III. Evaluate mechanisms of response and resistance using available tissue (archival or baseline) and circulating cell free tumor DNA (cfDNA) and circulating tumor cells (CTCs) at baseline, on treatment, and at progression.

IV. Evaluate efficacy parameters (objective response rate [ORR], PSA response, 9-month radiographic progression-free survival [rPFS], rPFS) based on arm allocation by:

IVa. DNA versus RNA qualifying molecular alterations; IVb. Blood versus tissue-based qualifying molecular alteration; IVc. Primary versus metastasis qualifying molecular alteration.

  1. Evaluate efficacy parameters (ORR, PSA response, 9-month rPFS, rPFS) based on the following clinical parameters:

Va. Presence or absence of visceral metastases at baseline; Vb. Number of prior lines of therapy for metastatic castration resistant cancer (mCRPC) (one versus \> 1); Vc. In patients having had prior exposure to taxane chemotherapy; Vd. Presence or absence of neuroendocrine differentiation at baseline. VI. Evaluate exceptional responders (defined as those with rPFS ≥ 18 months) and exceptional non-responders.

VII. To determine how circulating biomarker quantification correlates with clinical features and outcomes.

VIII. To determine the clinical impact of lineage plasticity alterations in predicting outcomes and response to therapy.

EXPLORATORY OBJECTIVE:

  1. To compare patient-assessed adverse events via PRO-CTCAE™ with clinician-assessed adverse events in each treatment arm.

OUTLINE: Patients undergo genetic testing on previously-collected tissue samples. Patients are then assigned to 1 of 3 arms based on genetic testing results and Molecular Tumor Board (MTB) decision.

ARM A: Patients receive valemetostat tosylate orally (PO) once daily (QD) on days 1-28 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.

ARM B: Patients receive carboplatin intravenously (IV) over 30 minutes and cabazitaxel IV over 60 minutes on day 1 of each cycle. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.

ARM C: Patients receive one of the following treatment regimens per treating physician: 1) Cabazitaxel IV over 60 minutes on day 1 of each cycle. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. 2) Abiraterone acetate PO QD on days 1-28 of each cycle and prednisone PO twice daily (BID) on days 1-28 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. 3) Enzalutamide PO QD on days 1-28 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. 4) Lutetium Lu 177 vipivotide tetraxetan IV on day 1 of each cycle. Treatment repeats every 42 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity.

All patients also undergo magnetic resonance imaging (MRI) or computed tomography (CT) and bone scan throughout the trial. Patients may also undergo optional fludeoxyglucose F-18 (FDG) or prostate-specific membrane antigen (PSMA) positron emission tomography (PET), as well as optional blood collection throughout the trial.

After completion of study treatment, patients without disease progression are followed every 2 months for the first 6 months and then every 3 months after that for up to 5 years. Patients with disease progression are followed every 6 months for 5 years.

Being tested
Genetic testing, Valemetostat Tosylate, Magnetic Resonance Imaging, Computed Tomography, Bone scan
Medical subject headings
Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Genetic testingOther

    undergo genetic testing

  • Valemetostat TosylateDrug

    Given PO

  • Magnetic Resonance ImagingProcedure or surgery

    Also called MRI

    undergo Magnetic Resonance Imaging

  • Computed TomographyProcedure or surgery

    Also called CAT Scan, CT Scan

    undergo Computed Tomography

  • Bone scanProcedure or surgery

    undergo Bone scan

  • FDG-Positron Emission TomographyProcedure or surgery

    Undergo FDG PET

  • PSMA PET ScanProcedure or surgery

    Also called Prostate-specific Membrane Antigen PET

    Undergo PSMA PET

  • Biospecimen CollectionProcedure or surgery

    undergo blood collection

  • CarboplatinDrug

    Given IV

  • CabazitaxelDrug

    Given IV

  • Abiraterone AcetateDrug

    Given PO

  • EnzalutamideDrug

    Also called Xtandi

    Given PO

  • Lutetium Lu 177 Vipivotide TetraxetanDrug

    Also called Pluvicto

    Given IV

Study groups in NCT06632977
Study groupRoleWhat they receive
Arm A (genetic testing, valemetostat tosylate)ExperimentalPatients undergo genetic testing on previously-collected tissue samples. Patients receive valemetostat tosylate PO QD on days 1-28 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo MRI or CT and bone scan throughout the trial. Patients may also undergo optional FDG or PSMA PET, as well as optional blood collection throughout the trial.
Receives: Other: Genetic testing; Drug: Valemetostat Tosylate; Procedure: Magnetic Resonance Imaging; Procedure: Computed Tomography; Procedure: Bone scan; Procedure: FDG-Positron Emission Tomography; Procedure: PSMA PET Scan; Procedure: Biospecimen Collection
Arm B (genetic testing, carboplatin, cabazitaxel)ExperimentalPatients undergo genetic testing on previously-collected tissue samples. Patients receive carboplatin IV over 30 minutes and cabazitaxel IV over 60 minutes on day 1 of each cycle. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients also undergo MRI or CT and bone scan throughout the trial. Patients may also undergo optional FDG or PSMA PET, as well as optional blood collection throughout the trial.
Receives: Other: Genetic testing; Procedure: Magnetic Resonance Imaging; Procedure: Computed Tomography; Procedure: Bone scan; Procedure: FDG-Positron Emission Tomography; Procedure: PSMA PET Scan; Procedure: Biospecimen Collection; Drug: Carboplatin; Drug: Cabazitaxel
Arm C (genetic testing, physician choice treatment)ExperimentalPatients undergo genetic testing on previously-collected tissue. Patients receive one of the following treatment regimens per treating physician: 1)Cabazitaxel IV over 60 minutes on day 1 of each cycle. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. 2)Abiraterone acetate PO QD on days 1-28 of each cycle and prednisone PO BID on days 1-28 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. 3) Enzalutamide PO QD on days 1-28 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. 4) Lutetium Lu 177 vipivotide tetraxetan IV on day 1 of each cycle. Treatment repeats every 42 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo MRI or CT and bone scan throughout the trial. Patients may also undergo optional FDG or PSMA PET, as well as optional blood collection throughout the trial.
Receives: Other: Genetic testing; Procedure: Magnetic Resonance Imaging; Procedure: Computed Tomography; Procedure: Bone scan; Procedure: FDG-Positron Emission Tomography; Procedure: PSMA PET Scan; Procedure: Biospecimen Collection; Drug: Cabazitaxel; Drug: Abiraterone Acetate; Drug: Enzalutamide; Drug: Lutetium Lu 177 Vipivotide Tetraxetan

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Objective Response

    Objective response is defined by modified Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 and Prostate Cancer Working Group 3 (PCWG3) for patients with measurable disease.

    Measured: Within 6 months from the start of treatment

Secondary outcomes (7)

  1. Radiographic Progression Free Survival (rPFS)

    Radiographic progression is defined by PCWG-3 for patients with bone metastases and modified RECIST 1.1 criteria for patients with soft tissue metastases. The 9-month radiographic progression-free proportion will be estimated by treatment arm, where patients who withdraw from study after the start of treatment but prior to nine months of follow-up will be counted as failures. rPFS will be calculated from registration date under progression or death by any cause, censoring event-free patients at the date of last disease evaluation. Will be estimated in each treatment arm using the Kaplan-Meier method.

    Measured: From initiation of treatment up to 9 months

  2. Overall Survival

    Will be calculated from registration date until death due to any cause, censoring event-free patients at the date of last contact. Will be estimated in each treatment arm using the Kaplan-Meier method.

    Measured: Up to 5 years after study registration

  3. Duration of Response

    Will be estimated according to RECIST v1.1 for patients with measurable disease in each treatment arm using the cumulative incidence function.

    Measured: Up to 5 years after study registration

  4. Prostate-specific antigen response

    Defined as greater than or equal to 50% decline in PSA from baseline using PCWG-3 criteria. Will be estimated as a proportion in each treatment arm.

    Measured: Through treatment completion, an average of one year

  5. Time to systematic skeletal events

    A skeletal related event is defined as the use of external beam radiotherapy to relieve skeletal symptoms or the occurrence of new symptomatic pathological bone fractures (vertebral or non-vertebral) or the occurrence of spinal cord compression or a tumor related orthopedic surgical intervention. Will be estimated in each treatment arm using the cumulative incidence function.

    Measured: Up to 5 years after registration

  6. Time to subsequent anti-cancer therapy

    Defined as time from registration to first subsequent anti-cancer therapy or death, censoring event-free patients at date of last follow-up. Will be estimated in each treatment arm using the cumulative incidence function.

    Measured: Up to 5 years after registration

  7. Rate of Grade 3+ AEs

    Will be collected and graded according ot the NCI CTCAE v5.0 criteria and per PRO-CTCAE.

    Measured: Up to 6 months after completion of study treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Oct 2024
  2. Study start6 Feb 2025
  3. Primary completion11 Apr 2030 (estimated)
  4. Study completion11 Oct 2034 (estimated)

Resources

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
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
474 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06632977
Sponsor's protocol ID
A032102
Other IDs
NCI-2024-04960
Acronym
PREDICT
Status last verified
Nov 2026
First submitted
1 Oct 2024
Last updated
3 Nov 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Chen YW, Xiu J, Poorman KA, Ryan CJ, Gilg B, Oberley MJ, Sura G, Sledge GW Jr, Zhao SG, Tan A, Beltran H, McKay RR. Clinical Utility of Transcriptomic Signatures to Identify Androgen Receptor and Neuroendocrine Signaling in Prostate Cancer. JCO Precis Oncol. 2026 Mar;10:e2500756. doi: 10.1200/PO-25-00756. Epub 2026 Mar 5.

    PubMed 41785440

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Genetic testing, Valemetostat Tosylate and Magnetic Resonance Imaging in people with Castration-Resistant Prostate Carcinoma and Stage IVB Prostate Cancer AJCC v8, run by Alliance for Clinical Trials in Oncology at 108 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 77 inclusion and 1 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 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 108 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?

Contact Rana McKay, MD (858-822-6185, rmckay@health.ucsd.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective Response (time frame: Within 6 months from the start of treatment). 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 NCT06632977, 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 3 Nov 2026.

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