RECRUITING Phase 2 ClinicalTrials.gov

Targeted Treatment for Metastatic Prostate Cancer, The PREDICT Trial

Sponsor: Alliance for Clinical Trials in Oncology • ClinicalTrials.gov ID: NCT06632977

Registry updated: 2026-10-02

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Description

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

Interventions

Genetic testing (Other)
undergo genetic testing
Valemetostat Tosylate (Drug)
Given PO
Magnetic Resonance Imaging (Procedure)
undergo Magnetic Resonance Imaging
Computed Tomography (Procedure)
undergo Computed Tomography
Bone scan (Procedure)
undergo Bone scan
FDG-Positron Emission Tomography (Procedure)
Undergo FDG PET
PSMA PET Scan (Procedure)
Undergo PSMA PET
Biospecimen Collection (Procedure)
undergo blood collection
Carboplatin (Drug)
Given IV
Cabazitaxel (Drug)
Given IV
Abiraterone Acetate (Drug)
Given PO
Enzalutamide (Drug)
Given PO
Lutetium Lu 177 Vipivotide Tetraxetan (Drug)
Given IV

Eligibility criteria

Inclusion Criteria: * 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): * 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. Exclusion Criteria: \-

Conditions

Castration-Resistant Prostate Carcinoma Stage IVB Prostate Cancer AJCC v8

Locations

University of Alabama at Birmingham Cancer Center — Birmingham, Alabama, United States
Banner University Medical Center - Tucson — Tucson, Arizona, United States
University of Arizona Cancer Center-North Campus — Tucson, Arizona, United States
Enloe Medical Center — Chico, California, United States
UC San Diego Health System - Encinitas — Encinitas, California, United States
UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care — Irvine, California, United States
UC San Diego Moores Cancer Center — La Jolla, California, United States
UC Irvine Health/Chao Family Comprehensive Cancer Center — Orange, California, United States
University of California Davis Comprehensive Cancer Center — Sacramento, California, United States
UC San Diego Medical Center - Hillcrest — San Diego, California, United States
UCHealth Memorial Hospital Central — Colorado Springs, Colorado, United States
Memorial Hospital North — Colorado Springs, Colorado, United States
Poudre Valley Hospital — Fort Collins, Colorado, United States
Cancer Care and Hematology-Fort Collins — Fort Collins, Colorado, United States
UCHealth Greeley Hospital — Greeley, Colorado, United States
Medical Center of the Rockies — Loveland, Colorado, United States
Stamford Hospital/Bennett Cancer Center — Stamford, Connecticut, United States
Beebe South Coastal Health Campus — Millville, Delaware, United States
Helen F Graham Cancer Center — Newark, Delaware, United States
Medical Oncology Hematology Consultants PA — Newark, Delaware, United States
Beebe Health Campus — Rehoboth Beach, Delaware, United States
Jupiter Medical Center — Jupiter, Florida, United States
Tripler Army Medical Center — Honolulu, Hawaii, United States
Kootenai Health - Coeur d'Alene — Coeur d'Alene, Idaho, United States
Illinois CancerCare-Bloomington — Bloomington, Illinois, United States
Illinois CancerCare-Canton — Canton, Illinois, United States
Carle at The Riverfront — Danville, Illinois, United States
Carle Physician Group-Effingham — Effingham, Illinois, United States
Illinois CancerCare-Eureka — Eureka, Illinois, United States
Carle Physician Group-Mattoon/Charleston — Mattoon, Illinois, United States
Cancer Care Center of O'Fallon — O'Fallon, Illinois, United States
Illinois CancerCare-Ottawa Clinic — Ottawa, Illinois, United States
Illinois CancerCare-Pekin — Pekin, Illinois, United States
Illinois CancerCare-Peoria — Peoria, Illinois, United States
Illinois CancerCare-Peru — Peru, Illinois, United States
Memorial Hospital East — Shiloh, Illinois, United States
Carle Cancer Center — Urbana, Illinois, United States
Illinois CancerCare - Washington — Washington, Illinois, United States
McFarland Clinic - Ames — Ames, Iowa, United States
University of Iowa Healthcare Cancer Services Quad Cities — Bettendorf, Iowa, United States
University of Iowa/Holden Comprehensive Cancer Center — Iowa City, Iowa, United States
University of Kansas Cancer Center — Kansas City, Kansas, United States
The University of Kansas Cancer Center - Olathe — Olathe, Kansas, United States
University of Kansas Hospital-Indian Creek Campus — Overland Park, Kansas, United States
University of Kansas Health System Saint Francis Campus — Topeka, Kansas, United States
University of Kansas Hospital-Westwood Cancer Center — Westwood, Kansas, United States
Saint Elizabeth Healthcare Edgewood — Edgewood, Kentucky, United States
Saint Elizabeth Healthcare Fort Thomas — Fort Thomas, Kentucky, United States
Dana-Farber Cancer Institute — Boston, Massachusetts, United States
Dana-Farber Cancer Institute at Foxborough — Foxborough, Massachusetts, United States
Dana Farber-Merrimack Valley — Methuen, Massachusetts, United States
Dana-Farber/Brigham and Women's Cancer Center at Milford Regional — Milford, Massachusetts, United States
Dana-Farber/Brigham and Women's Cancer Center at South Shore — South Weymouth, Massachusetts, United States
Baystate Medical Center — Springfield, Massachusetts, United States
Trinity Health IHA Medical Group Hematology Oncology - Brighton — Brighton, Michigan, United States
Trinity Health IHA Medical Group Hematology Oncology - Canton — Canton, Michigan, United States
Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital — Chelsea, Michigan, United States
University of Michigan Health - Sparrow Lansing — Lansing, Michigan, United States
Trinity Health Saint Mary Mercy Livonia Hospital — Livonia, Michigan, United States
Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus — Ypsilanti, Michigan, United States
Essentia Health Saint Joseph's Medical Center — Brainerd, Minnesota, United States
Essentia Health Cancer Center — Duluth, Minnesota, United States
Coborn Cancer Center at Saint Cloud Hospital — Saint Cloud, Minnesota, United States
Siteman Cancer Center at Saint Peters Hospital — City of Saint Peters, Missouri, United States
MU Health - University Hospital/Ellis Fischel Cancer Center — Columbia, Missouri, United States
Siteman Cancer Center at West County Hospital — Creve Coeur, Missouri, United States
Washington University School of Medicine — St Louis, Missouri, United States
Siteman Cancer Center-South County — St Louis, Missouri, United States
Siteman Cancer Center at Christian Hospital — St Louis, Missouri, United States
Billings Clinic Cancer Center — Billings, Montana, United States
Hackensack University Medical Center — Hackensack, New Jersey, United States
Roswell Park Cancer Institute — Buffalo, New York, United States
Mount Sinai Hospital — New York, New York, United States
UNC Lineberger Comprehensive Cancer Center — Chapel Hill, North Carolina, United States
Essentia Health Cancer Center-South University Clinic — Fargo, North Dakota, United States
MetroHealth Medical Center — Cleveland, Ohio, United States
Ohio State University Comprehensive Cancer Center — Columbus, Ohio, United States
University of Oklahoma Health Sciences Center — Oklahoma City, Oklahoma, United States
Providence Portland Medical Center — Portland, Oregon, United States
Providence Saint Vincent Medical Center — Portland, Oregon, United States
Oregon Health and Science University — Portland, Oregon, United States
Guthrie Medical Group PC-Robert Packer Hospital — Sayre, Pennsylvania, United States
Gibbs Cancer Center-Gaffney — Gaffney, South Carolina, United States
Gibbs Cancer Center-Pelham — Greer, South Carolina, United States
Spartanburg Medical Center — Spartanburg, South Carolina, United States
SMC Center for Hematology Oncology Union — Union, South Carolina, United States
Vanderbilt University/Ingram Cancer Center — Nashville, Tennessee, United States
Parkland Memorial Hospital — Dallas, Texas, United States
UT Southwestern Simmons Cancer Center - RedBird — Dallas, Texas, United States
UT Southwestern/Simmons Cancer Center-Dallas — Dallas, Texas, United States
UT Southwestern/Simmons Cancer Center-Fort Worth — Fort Worth, Texas, United States
UT Southwestern Clinical Center at Richardson/Plano — Richardson, Texas, United States
Bon Secours Memorial Regional Medical Center — Mechanicsville, Virginia, United States
Bon Secours Saint Francis Medical Center — Midlothian, Virginia, United States
Bon Secours Richmond Community Hospital — Richmond, Virginia, United States
Bon Secours Saint Mary's Hospital — Richmond, Virginia, United States
Bon Secours Cancer Institute at Reynolds Crossing — Richmond, Virginia, United States
VCU Massey Cancer Center at Stony Point — Richmond, Virginia, United States
VCU Massey Comprehensive Cancer Center — Richmond, Virginia, United States
Swedish Cancer Institute-Edmonds — Edmonds, Washington, United States
Swedish Medical Center-First Hill — Seattle, Washington, United States
Vandalia Health/CAMC Institute for Academic Medicine — Charleston, West Virginia, United States
Edwards Comprehensive Cancer Center — Huntington, West Virginia, United States
Marshfield Medical Center-Marshfield — Marshfield, Wisconsin, United States
Froedtert Menomonee Falls Hospital — Menomonee Falls, Wisconsin, United States
Medical College of Wisconsin — Milwaukee, Wisconsin, United States
Drexel Town Square Health Center — Oak Creek, Wisconsin, United States
Froedtert West Bend Hospital/Kraemer Cancer Center — West Bend, Wisconsin, United States

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Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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