Actively Recruiting
A Randomized Open-label Phase 2 Study of Talazoparib With or Without Enzalutamide in Patients With Metastatic Castration-Resistant Prostate Cancer and HRR Mutations After Progression on Abiraterone Acetate
Led by Prostate Cancer Clinical Trials Consortium · Updated on 2026-04-24
126
Participants Needed
2
Research Sites
52 weeks
Total Duration
On this page
Sponsors
P
Prostate Cancer Clinical Trials Consortium
Lead Sponsor
P
Pfizer
Collaborating Sponsor
AI-Summary
What this Trial Is About
The trial investigates whether using talazoparib alone or combined with enzalutamide can delay cancer progression in men with metastatic castration-resistant prostate cancer (mCRPC) who have specific homologous recombination repair (HRR) mutations and have previously been treated with abiraterone acetate. The study is a randomized, open-label Phase 2 trial focused on this specific patient population. It aims to understand how these treatments affect disease progression and other health outcomes over time. Participants will be assigned randomly to one of two treatment groups. One group will receive talazoparib at 0.5 mg daily combined with enzalutamide at 160 mg daily, while the other group will receive talazoparib alone at 1 mg daily. Both treatments are given orally in continuous 28-day cycles. The study tracks how these regimens perform over the course of treatment. During the study, participants will undergo imaging scans and blood tests to monitor cancer progression and other health parameters. Researchers will assess outcomes such as radiographic progression-free survival, time to PSA50 response, PSA progression, quality of life using validated questionnaires, adverse events, and overall survival. These evaluations occur from treatment start and continue through follow-ups lasting up to 42 months. Safety and tolerability are monitored throughout the trial period.
CONDITIONS
Brief Title
A Study of Talazoparib With or Without Enzalutamide in People With Prostate Cancer Who Have Previously Received Abiraterone Acetate
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants 18 years of age or older
- Male patients with histological or cytological proof of adenocarcinoma of the prostate without neuroendocrine or small cell features
- Presence of a pathogenic homologous recombination repair mutation confirmed by certified testing
- Diagnosis of metastatic castration-resistant prostate cancer documented by imaging or PSMA PET
- Prior treatment with abiraterone acetate and prednisone with evidence of progression
- Surgically or medically castrated with testosterone levels below 50 ng/dL
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- Normal organ function based on laboratory tests within 14 days of treatment
- Ability to swallow study capsules or tablets whole
- Willingness to be randomized and adhere to study protocol
- Agreement to use effective contraception or sexual abstinence during and 4 months after study treatment
You will not qualify if you...
- Having another active malignancy requiring treatment within 3 years except certain cured skin or bladder cancers
- Prior treatment with androgen receptor pathway inhibitors other than abiraterone acetate with prednisone for 12 weeks or more
- Chemotherapy for castration-sensitive prostate cancer completed less than 6 months before study
- Use of investigational agents within 4 weeks before study treatment
- Prior treatment with PARP inhibitors or platinum-based chemotherapy for prostate cancer
- Concurrent treatment with crizotinib
- Use of potent P-gp inhibitors or certain CYP450 inhibitors or inducers before randomization
- Use of hormonal agents with anti-tumor activity against prostate cancer within 28 days before treatment
- Use of herbal or alternative therapies affecting PSA or hormones within 28 days before treatment
- Recent blood transfusion within 14 days before randomization
- History of seizure, significant brain trauma, or recent loss of consciousness
- Uncontrolled hypertension, diabetes, or cardiac disease precluding participation
- Untreated brain metastases, spinal cord compression, or malignant epidural disease
- Grade higher than 2 treatment-related toxicity from prior therapy except alopecia or peripheral neuropathy
- Known allergy to study drugs
- Any other condition that investigators deem unsuitable for participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit
Duration - Repeated 28-day cycles until disease progression or discontinuation
Participants receive Talazoparib with or without enzalutamide in continuous 28-day cycles.
Visits occur in alignment with each 28-day treatment cycle
Duration - Up to 12 months after treatment completion
Participants are monitored for adverse events and survival for up to 12 months after treatment ends.
Regular follow-up visits during this period
Trial Site Locations
Total: 2 locations
1
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02215
Actively Recruiting
2
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Actively Recruiting
Research Team
S
Sarah Wise
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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