OncoMatch/Clinical Trials/NCT06632977
Targeted Treatment for Metastatic Prostate Cancer, The PREDICT Trial
Is NCT06632977 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments for castration-resistant prostate carcinoma.
Treatment: Valemetostat Tosylate · Carboplatin · Cabazitaxel · Abiraterone Acetate · Enzalutamide · Lutetium Lu 177 Vipivotide Tetraxetan — 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
Check if I qualifyExtracted eligibility criteria
Cancer type
Prostate Cancer
Biomarker criteria
Required: FOLH1 overexpression (PSMA positive as determined by investigator assessment)
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.
Allowed: BRCA1 deleterious mutation
Patients with known germline or somatic deleterious BRCA 1/2 mutations must have received a prior PARPi.
Allowed: BRCA2 deleterious mutation
Patients with known germline or somatic deleterious BRCA 1/2 mutations must have received a prior PARPi.
Disease stage
Required: Stage IVB
Metastatic disease required
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: androgen receptor signaling inhibitor — metastatic hormone sensitive or mCRPC
Prior treatment with androgen receptor signaling inhibitor (ARSI) in either the metastatic hormone sensitive setting or mCRPC is required.
Must have received: taxane — metastatic hormone sensitive or mCRPC
Prior taxane therapy in either metastatic hormone sensitive setting or mCRPC is mandated unless patient is taxane ineligible or the patient refuses taxane therapy.
Must have received: PARP inhibitor
Patients with known germline or somatic deleterious BRCA 1/2 mutations must have received a prior PARPi.
Must have received: cabazitaxel + carboplatin (cabazitaxel, carboplatin)
Prior treatment with cabazitaxel + carboplatin.
Cannot have received: EZH inhibitor
No prior treatment with EZH inhibitors.
Lab requirements
Blood counts
WBC ≥ 2,500/mcL; ANC ≥ 1,500/mcL; Hemoglobin ≥ 9 g/dL; Platelet count ≥ 100,000/mcL
Kidney function
Creatinine clearance ≥ 30 mL/min as defined by Cockcroft-Gault equation
Liver function
Total bilirubin ≤ 1.5 x ULN (≤ 3 x ULN for subjects with documented Gilbert's disease); AST and ALT ≤ 3 x ULN; Albumin ≥ 2.8 g/dL; Moderate to severe hepatic impairment (Child-Pugh Class C) excluded
Cardiac function
QTcF < 470 ms (in individuals with any cardiac history or medication/condition known to impact QTcF); No myocardial infarction or uncontrolled angina within 6 months; No NYHA Class 3 or 4 CHF; No uncontrolled hypertension (SBP >160 mmHg or DBP >100 mmHg)
WBC ≥ 2,500/mcL; ANC ≥ 1,500/mcL; Hemoglobin ≥ 9 g/dL; Platelet count ≥ 100,000/mcL; Creatinine clearance ≥ 30 mL/min as defined by Cockcroft-Gault equation; Total bilirubin ≤ 1.5 x ULN (≤ 3 x ULN for subjects with documented Gilbert's disease); AST and ALT ≤ 3 x ULN; Albumin ≥ 2.8 g/dL; QTcF < 470 ms; No myocardial infarction or uncontrolled angina within 6 months; No NYHA Class 3 or 4 CHF; No uncontrolled hypertension (SBP >160 mmHg or DBP >100 mmHg)
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Banner University Medical Center - Tucson · Tucson, Arizona
- University of Arizona Cancer Center-North Campus · Tucson, Arizona
- UC San Diego Health System - Encinitas · Encinitas, California
- UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care · Irvine, California
- UC San Diego Moores Cancer Center · La Jolla, California
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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