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.
Participants ≥ 18 years of age.
Are willing to be randomized into either study arm and adhere to the study protocol.
Ability to swallow study capsules and/or tablets whole.
Are willing to remain on study treatment and to continue undergoing study imaging despite PSA progression unless clinically deteriorating.
Any other active malignancy at time of first dose of study treatment or diagnosis of another malignancy within 3 years prior to first dose of study treatment that requires active treatment, except for locally curable cancers that have been apparently cured, such as basal or squamous cell skin cancer or superficial bladder cancer.
Prior treatment for metastatic or non-metastatic CRPC with an ARPI other than abiraterone acetate with prednisone for ≥ 12 weeks. Prior treatment with abiraterone acetate with prednisone in the mHSPC or locally advanced setting is not exclusionary.
Participants who received chemotherapy for castration-sensitive prostate cancer are still eligible provided chemotherapy was completed >6 months prior to start of study treatment.
Use of investigational agents for the treatment of prostate cancer within 4 weeks of start of study treatment.
Prostate Cancer Clinical Trials Consortium
Lead sponsor
Pfizer
Collaborator
Dana-Farber Cancer Institute
Collaborator
Memorial Sloan Kettering Cancer Center
Collaborator