A Study of Talazoparib With or Without Enzalutamide in People With Prostate Cancer Who Have Previously Received Abiraterone Acetate

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Prostate Cancer Clinical Trials Consortium
Study ID
NCT06844383
Phase
PHASE2
Status
Recruiting
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Conditions

  • Prostate Cancer (Adenocarcinoma)
  • mCRPC (Metastatic Castration-resistant Prostate Cancer)

Eligibility Criteria

Sex
MALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Talazoparib with enzalutamide — DRUG
    Talazoparib (0.5 mg PO QD) and enzalutamide (160 mg PO QD) will be administered in continuous 28-day cycles.
  • Talazoparib — DRUG
    Talazoparib (1 mg PO QD) will be administered in continuous 28-day cycles.

Study Details

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.

Key Dates

Start date
May 31, 2026
Status verified
Oct 2025
Primary completion
Mar 31, 2029
Completion
Mar 31, 2030

Study Design

Enrollment
126 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Arm A
    Talazoparib (0.5 mg PO QD) and enzalutamide (160 mg PO QD) will be administered in continuous 28-day cycles.
  • Experimental: Arm B
    Talazoparib (1 mg PO QD) will be administered in continuous 28-day cycles.

Primary Outcome Measure

radiographic progression free survival (rPFS) [ Time Frame: From treatment initiation until documented disease progression, death, lost to follow-up, withdrawal, administrative censoring at the time of final analysis, assessed at approximately 42 months from the start of enrollment. ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Dana Farber Cancer InstituteBostonMassachusetts02215
Alicia Morgans, MD
[email protected]
617-632-3466
Memorial Sloan Kettering Cancer CenterNew YorkNew York10065
Karen Autio, MD
[email protected]
646-422-4632

Find similar trials in Boston, MA

By research site
Dana Farber Cancer Institute· Boston, MAMemorial Sloan Kettering Cancer Center· New York, NY

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