OncoMatch/Clinical Trials/NCT06582628
Talazoparib Plus Enzalutamide After Progression to Prior ARPi in Metastatic Prostate Cancer
Official title: A Multicenter, Open Label, Randomized Phase II Trial to Evaluate the Efficacy of Talazoparib Plus Enzalutamide as First Line Treatment for Patients With Metastatic Castration Resistant Prostate Cancer After Progression to an Androgen Receptor Pathway Inhibitor
Is NCT06582628 recruiting? Yes, currently enrolling (Oct 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 Androgen Receptor Pathway Inhibitor (ARPI). 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
Treatments studied
Other
Cancer type
Prostate Cancer
Disease stage
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)
Demographics
Prior therapy
Must have received: androgen receptor pathway inhibitor (abiraterone acetate, enzalutamide, apalutamide, darolutamide) — metastatic hormone-sensitive prostate cancer
Disease progression after at least 12 weeks of treatment with a prior androgen-receptor signalling inhibitor (ARPi), including abiraterone acetate or a direct AR inhibitor, such as enzalutamide, apalutamide, or darolutamide, for metastatic hormone-sensitive prostate cancer
Cannot have received: androgen receptor pathway inhibitor (abiraterone, enzalutamide, apalutamide, darolutamide)
Exception: Patients who started on one ARPi and switched to another due to toxicity may be eligible with study chair approval if on first ARPi (other than enzalutamide) for a very limited period and were responding at switch
Prior treatment with more than one ARPi. This will include abiraterone, enzalutamide, apalutamide, or darolutamide, which are treatments with demonstrated PFS and/or OS benefit in mHPSC, as well as any other novel AR or androgen synthesis directed therapy (with the exception on LHRH/GnRH analogues and/or antagonists). Note: Patients who started on one ARPi and switched to another due to toxicity will only be eligible after prior discussion with the study chair, provided that they were on the first ARPi (other than enzalutamide) for a very limited period of time and can document that they were responding - without PSA rise or worsening symptoms - at the moment they were switched to the second ARPi. Inclusion of such cases will require written notification and approval from the study chair or co-chair.
Cannot have received: androgen receptor pathway inhibitor (abiraterone, enzalutamide, apalutamide, darolutamide)
Exception: Prior ARPi treatment for less than 12 weeks or disease progression within 6 months of starting abiraterone or ARi
Prior ARPi treatment for less than 12 weeks or disease progression (either PSA or radiographic progression) within 6 months of starting abiraterone or ARi
Cannot have received: docetaxel (docetaxel)
Exception: Received a maximum of 6 cycles for mHSPC and last dose >= 6 months prior to randomization
Participants who have received prior docetaxel must meet the following criteria: a. Received a maximum of 6 cycles of docetaxel for mHSPC and b. Received the last dose of docetaxel equal or higher than 6 months prior to randomization.
Cannot have received: Lu177-PSMA (Lu177-PSMA)
Exception: Received a maximum of 6 cycles for mHSPC and last dose >= 6 months prior to randomization
Participants who have received prior Lu177-PSMA must meet the following criteria: a. Received a maximum of 6 cycles of docetaxel for mHSPC. b. Received the last dose of Lu177-PSMA equal or higher than 6 months prior to randomization
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)
Kidney function
Serum creatinine < 1.5X ULN or calculated creatinine clearance ≥ 50 mL/min
Liver function
AST or ALT < 2.5 × ULN (or < 5 × ULN if liver function abnormalities are due to hepatic metastasis); total serum bilirubin < 1.5 × ULN (or < 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: 1. Haemoglobin ≥ 10 g/dL, no blood transfusions within 14 days before obtaining the haematology laboratory tests at screening, 2. Platelets ≥ 100,000/μL no platelets transfusions within 14 days before obtaining the haematology laboratory tests at screening, 3. Neutrophils ≥ 1500/μL, no growth factors given within 14 days before obtaining the haematology laboratory tests at screening, 4. Serum creatinine <1.5X ULN or calculated creatinine clearance ≥ 50 mL/min 5. Albumin > 3 g/dL, 6. AST or ALT < 2.5 × ULN (< 5 × ULN if liver function abnormalities are due to hepatic metastasis). 7. 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.
Frequently asked questions
Is NCT06582628 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior androgen receptor pathway inhibitor, androgen receptor pathway inhibitor, docetaxel disqualifies patients from enrollment.
Is this trial open to female patients?
No. This trial enrolls male patients only.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages