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

Phase 2

Not yet recruiting

• Conditions: Prostate Cancer (Adenocarcinoma); mCRPC (Metastatic Castration-resistant Prostate Cancer)
• Interventions: Drug: Talazoparib with enzalutamide; Drug: Talazoparib

• Registration Number: NCT06844383
• Lead Sponsor: Prostate Cancer Clinical Trials Consortium

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-02-07
• Study First Submitted QC: 2025-02-19
• Study First Posted: 2025-02-25
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-27
• Last Update Posted: 2025-05-31
• Study Start: 2025-09
• Primary Completion: 2028-12
• Study Completion: 2029-03

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Male
• Target Recruitment: 126

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm A	Talazoparib with enzalutamide	Talazoparib (0.5 mg PO QD) and enzalutamide (160 mg PO QD) will be administered in continuous 28-day cycles.
Arm B	Talazoparib	Talazoparib (1 mg PO QD) will be administered in continuous 28-day cycles.

Primary Outcome Measures

Name	Time	Method
radiographic progression free survival (rPFS)	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.	To compare the efficacy of talazoparib + enzalutamide to talazoparib alone as measured by rPFS as assessed by the Investigator.

Secondary Outcome Measures

Name	Time	Method
Time to PSA50	Time from treatment initiation until observed PSA50, assessed at approximately 42 months from the start of enrollment.	To compare the efficacy of talazoparib + enzalutamide to talazoparib alone as measured by time to prostate specific antigen (PSA) ≥ 50% decline.
Time to PSA Progression	From treatment initiation until documented PSA progression, assessed at approximately 42 months from the start of enrollment.	To compare the efficacy of talazoparib + enzalutamide to talazoparib alone as measured by time to PSA progression.
Quality of Life (QoL) by Functional Assessment of Cancer Therapy-Prostate (FACT-P)	From prior to treatment initiation (screening) until treatment discontinuation, assessed at approximately 42 months from the start of enrollment.	Overall QoL measured by FACT-P. Scales: FACT-P Total score (range 0-156), FACT-General (G) Total score (range 0-108), FACT-P Trial Outcome Index (TOI) score (range 0-104). The higher the score, the better the QOL.
Quality of Life (QoL) by Functional Assessment of Cancer Intervention Therapy-Fatigue Scale (FACIT-Fatigue)	From prior to treatment initiation (screening) until treatment discontinuation, assessed at approximately 42 months from the start of enrollment.	Fatigue measured by FACIT-Fatigue. Scales: FACIT-F Total score (range 0-160), FACT-General (G) Total score (range 0-108), FACIT-F Trial Outcome Index (TOI) score (range 0-108). The higher the score, the better the QOL.
Quality of Life (QoL) by Functional Assessment of Cancer Therapy-Cognitive Function (FACT-Cog)	From prior to treatment initiation (screening) until treatment discontinuation, assessed at approximately 42 months from the start of enrollment.	Cognitive function measured by FACT-Cog. Subscales: Perceived Cognitive Impairments (CogPCI) score (range 0-72), Impact of Perceived Cognitive Impairments on Quality of Life (CogQOL) score (range 0-16), Comments from Others (CogOth) score (range 0-16), Perceived Cognitive Abilities (CogPCA) score (range 0-28). The higher the score, the better the QOL.
Adverse Events (AE)	From treatment initiation through follow up, up to 12 months from end of treatment, assessed at approximately 42 months from the start of enrollment.	Evaluate AE occurrence according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 to confirm safety.
Overall Survival (OS)	From treatment initiation until death, lost to follow-up, withdrawal, administrative censoring at the time of final analysis, assessed at approximately 42 months from the start of enrollment.	To compare the efficacy of talazoparib + enzalutamide to talazoparib alone as measured by OS.

Trial Locations

Locations (2)

Dana Farber Cancer Institute; 🇺🇸 Boston, Massachusetts, United States

Memorial Sloan Kettering Cancer Center; 🇺🇸 New York, New York, United States