OncoMatch/Clinical Trials/NCT06582628
Talazoparib Plus Enzalutamide After Progression to Abiraterone in Metastatic Prostate Cancer: (TEAM PC)
Is NCT06582628 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Enzalutamide capsule and Enzalutamide capsule and Talazoparib capsule for metastatic prostate cancer.
Treatment: Enzalutamide capsule · Enzalutamide capsule and Talazoparib capsule — The purpose of this clinical trial is to determine the anti-tumor activity of talazoparib plus enzalutamide as first line treatment for metastatic castration resistant prostate cancer (mCRPC) in participants whose disease has progressed on abiraterone. The main questions it aims to answer are: * Does talazoparib plus enzalutamide improve efficacy in metastatic castration resistant prostate cancer (mCRPC) compared to enzalutamide alone? * What is the time to disease progression \[radiographic, Prostate Specific Antigen (PSA), clinical\] in participants treated with talazoparib plus enzalutamide after progression on abiraterone? * What medical problems do participants have when receiving talazoparib plus enzalutamide? Researchers will compare the combination of talazoparib and enzalutamide as a first-line treatment for mCRPC to see if the combination improves the PSA response rate and delays progression compared to enzalutamide alone. The safety and tolerability of the combination (talazoparib and enzalutamide) will also be studied
Check if I qualifyExtracted eligibility criteria
Cancer type
Prostate Cancer
Disease stage
Required: Stage IV
Metastatic disease required
Metastatic (M1) prostate cancer documented by bone scan, or soft tissue disease documented by computed tomography (CT), or magnetic resonance imaging (MRI).
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: abiraterone (abiraterone) — metastatic hormone-sensitive prostate cancer
Disease progression after at least 12 weeks of treatment with abiraterone for metastatic hormone-sensitive prostate cancer.
Cannot have received: abiraterone (abiraterone)
Exception: less than 12 weeks or progression within 6 months of starting abiraterone
Prior abiraterone treatment for less than 12 weeks or disease progression (either PSA or radiographic progression) within 6 months of starting abiraterone.
Cannot have received: docetaxel (docetaxel)
Exception: disease progression less than 6 months after last administration for mHSPC
Disease progression less than 6 months after the last administration of docetaxel for mHSPC.
Cannot have received: AR-targeted therapy (enzalutamide, apalutamide, darolutamide, ketoconazole)
Exception: other than abiraterone for mHSPC
Prior treatment with an AR-targeted therapy (enzalutamide, apalutamide, darolutamide, ketoconazole) other than abiraterone for mHSPC
Cannot have received: chemotherapy
Exception: other than 6 cycles of docetaxel for mHSPC
chemotherapy other than 6 cycles of docetaxel for mHSPC
Cannot have received: immunotherapy
immunotherapy
Cannot have received: radiopharmaceuticals
radiopharmaceuticals
Lab requirements
Blood counts
Haemoglobin ≥ 10 g/dL (no transfusions within 14 days); Platelets ≥ 100,000/μL (no transfusions within 14 days); Neutrophils ≥ 1500/μL (no growth factors within 14 days); Albumin > 3 g/dL
Kidney function
Serum creatinine < 1.5X ULN or calculated creatinine clearance ≥ 50 mL/min
Liver function
AST or ALT < 2.5 × ULN ( < 5 × ULN if liver function abnormalities due to hepatic metastasis); total serum bilirubin < 1.5 × ULN ( < 3 × ULN for Gilbert syndrome or extrahepatic source)
Adequate organ function within 28 days before the first study treatment on Day 1, defined by the following: Haemoglobin ≥ 10 g/dL, no blood transfusions within 14 days before obtaining the haematology laboratory tests at screening, Platelets ≥ 100,000/μL no platelets transfusions within 14 days before obtaining the haematology laboratory tests at screening, Neutrophils ≥ 1500/μL, no growth factors given within 14 days before obtaining the haematology laboratory tests at screening, Serum creatinine <1.5X ULN or calculated creatinine clearance ≥ 50 mL/min, Albumin > 3 g/dL, AST or ALT < 2.5 × ULN (< 5 × ULN if liver function abnormalities are due to hepatic metastasis). Total serum bilirubin < 1.5 × ULN (< 3 × ULN for participants with documented Gilbert syndrome or for whom indirect bilirubin concentrations suggest an extrahepatic source of elevation).
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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