NCT06632977 · Alliance for Clinical Trials in Oncology
Targeted Treatment for Metastatic Prostate Cancer, The PREDICT Trial
(PREDICT)
What this study is about
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.
View original scientific 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.
Interventions
OTHER
Genetic testing
undergo genetic testing
DRUG
Valemetostat Tosylate
Given PO
PROCEDURE
Magnetic Resonance Imaging
undergo Magnetic Resonance Imaging
PROCEDURE
Computed Tomography
undergo Computed Tomography
PROCEDURE
Bone scan
undergo Bone scan
PROCEDURE
FDG-Positron Emission Tomography
Undergo FDG PET
PROCEDURE
PSMA PET Scan
Undergo PSMA PET
PROCEDURE
Biospecimen Collection
undergo blood collection
DRUG
Carboplatin
Given IV
DRUG
Cabazitaxel
Given IV
DRUG
Abiraterone Acetate
Given PO
DRUG
Enzalutamide
Given PO
DRUG
Lutetium Lu 177 Vipivotide Tetraxetan
Given IV
Primary outcome measures
Objective Response
Time frame: Within 6 months from the start of treatment
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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 q
Where
- Birmingham, Alabama
- Tucson, Arizona
- Chico, California
- Encinitas, California
- Irvine, California
- La Jolla, California
- Orange, California
- Sacramento, California
- San Diego, California
- Colorado Springs, Colorado
- Fort Collins, Colorado
- Greeley, Colorado
And 81 more locations — see the full list below.
Collaborators
National Cancer Institute (NCI)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 2, 2026 · Source of record for eligibility and locations