Clinical Trials

Inclusion Criteria:

• Men, ≥ 18 years of age.
• Diagnosis of metastatic (Stage IV) prostate cancer (PC), confirmed by either biopsy of a metastatic tumor site or history of localized disease supported by metastatic disease on imaging studies; (i.e., clearly noted in hospital/clinical records). Subjects must have mHSPC as defined by starting androgen deprivation therapy (ADT) (surgical or chemical castration) within 6 months of enrollment
• Signed Informed consent form (ICF).
• No condition for which, in the opinion of the investigator, participation would not be in the best interest of the participant (e.g., compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments.
• Willing to provide a saliva, blood, and/or archival tumor tissue for genomic analysis.
• No prior PARPi for the treatment of prostate cancer.
• No prior DNA-repair gene defect results from the same assay performed on a Janssen-sponsored interventional trial
• No more than 90 days of prior abiraterone acetate therapy and no prior therapy with other next generation androgen signaling inhibitor therapy (e.g., enzalutamide, apalutamide, darolutamide).
• No more than 6 months of androgen deprivation therapy for treatment of metastatic prostate cancer.

Exclusion Criteria:

• Men, < 18 years of age.

Eligibility last updated 9/28/21. Questions regarding updates should be directed to the study team contact.