Actively Recruiting
A Study of Talazoparib With or Without Enzalutamide in People With Prostate Cancer Who Have Previously Received Abiraterone Acetate
Led by Prostate Cancer Clinical Trials Consortium · Updated on 2026-04-24
126
Participants Needed
2
Research Sites
200 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 purpose of this study is to find out whether talazoparib in combination with enzalutamide or talazoparib alone delays cancer progression in people with metastatic castration-resistant prostate cancer (mCRPC) who have homologous recombination repair (HRR) mutations and have previously received abiraterone acetate.
CONDITIONS
Official 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...
- Willing and able to provide written informed consent and privacy authorization.
- Participants aged 18 years or older.
- Willing to be randomized and follow the study protocol.
- Able to swallow study capsules and/or tablets whole.
- Willing to remain on study treatment and continue imaging despite PSA progression unless clinical deterioration occurs.
- Histological or cytological confirmation of prostate adenocarcinoma without neuroendocrine or small cell features.
- Presence of a pathogenic homologous recombination repair mutation in specified genes confirmed by CLIA-certified testing.
- Metastatic castration-resistant prostate cancer documented by imaging or PSMA PET.
- Prior treatment with abiraterone acetate and prednisone for mHSPC or locally advanced disease with progression.
- Progressive disease under medical or surgical castration as defined by PSA or radiographic criteria.
- Surgically or medically castrated with testosterone levels <50 ng/dL, with continuous dosing if medically castrated.
- ECOG performance status of 0 or 1.
- Normal organ function based on specified laboratory values within 14 days before treatment start.
- Agreement to use acceptable birth control or abstinence during study and for 4 months after last dose; prohibition of sperm donation during this time.
You will not qualify if you...
- Any other active malignancy requiring treatment within 3 years except for certain cured cancers.
- Prior treatment for metastatic or non-metastatic CRPC with ARPI other than abiraterone acetate for 12 weeks or more.
- Chemotherapy for castration-sensitive prostate cancer completed less than 6 months before study.
- Use of investigational prostate cancer agents within 4 weeks before study.
- Prior treatment with any PARP inhibitor.
- Concurrent treatment with crizotinib.
- Prior platinum-based chemotherapy for prostate cancer.
- Use of potent P-gp inhibitors within 7 days before randomization.
- Use of strong or moderate CYP450 enzyme inhibitors or inducers that affect study drugs unless medically necessary.
- Use of hormonal agents with anti-tumor activity or certain herbal/alternative therapies within 28 days before study.
- Receiving blood transfusion within 14 days before randomization.
- History of seizure or conditions predisposing to seizure, recent loss of consciousness or transient ischemic attack.
- Uncontrolled hypertension, diabetes, or cardiac disease preventing participation.
- Untreated brain metastases, spinal cord compression, or significant malignant epidural disease.
- Use of prohibited concomitant medications within 28 days prior to study.
- Grade greater than 2 treatment-related toxicity from prior therapy except alopecia or peripheral neuropathy.
- Known allergy to study compounds.
- Any other condition judged by the investigator to preclude participation.
AI-Screening
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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
CONTACT
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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