Title
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 (TALENT)

Description
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

Objective
Primary Objective
- To compare the efficacy of talazoparib + enzalutamide to talazoparib alone as measured by rPFS as assessed by the Investigator.

Secondary Objectives
- To compare PSA response defined by time to >= 50% decline in PSA from baseline.
- To compare time to PSA progression (time from treatment initiation to PSA progression by PCWG 3 criteria).
- To compare participant-reported quality of life (QOL), longitudinally between arms using the Functional Assessment of Cancer Therapy-Prostate (FACT-P), Functional Assessment of Cancer Intervention Therapy-Fatigue Scale (FACIT-Fatigue), and Functional Assessment of Cancer Therapy-Cognitive Function (FACT-Cog) measures.
- To compare safety and tolerability according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. Adverse events of special interest will include second primary malignancies, pneumonitis, venous thromboembolic events/ myelodysplastic syndrome (MDS)/acute myeloid leukemia (AML).
- To evaluate OS between arms at the end of the follow-up period.

Treatment 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 Eligibility For full study eligibility see this study's ClinicalTrials.gov record.

Applicable Disease Sites
Prostate

Participating Institutions
UW Health Eastpark Medical Center; UW Health University Hospital