A Study of Niraparib Combination Therapies for the Treatment of Metastatic Castration-Resistant Prostate Cancer


About this study

The purpose of this study is to establish the recommended phase 2 dose (RP2D) of niraparib combination therapies of Part 1 and to evaluate the antitumor activity and safety of niraparib combination therapies of Part 2.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria: 

  • Participants willing to undergo all protocol-specified biopsies.
  • Diagnosis of prostate adenocarcinoma as confirmed by the investigator.
  • Combination 1: 
    • Must have determination of biomarker (BM) status for DNA-repair gene defects (DRD) (either BM positive [+] or BM negative [-]) by the sponsor's blood or tissue assay;
    • Participants must have measurable disease as defined by response evaluation criteria in solid tumors (RECIST) 1.1 (soft tissue lesion of greater than or equal to (≥) 10 millimeter (mm) in the long axis or extrapelvic lymph node of ≥ 15 mm in the short axis);
    • Must have previously received at least 1, but no more than 2, lines of novel androgen receptor (AR)-targeted therapy (that is, abiraterone acetate with prednisone, enzalutamide) for metastatic castration-resistant prostate cancer (mCRPC). Participants must have had at least 4 weeks of AR-targeted therapy.
  • Combination 2:
    • Must be biomarker positive for DRD by either the sponsor's blood or tissue assay;
    • Must have progressed on 1 prior line of novel AR-targeted therapy (that is, abiraterone acetate with prednisone, enzalutamide) for mCRPC;
    • Prior treatment with taxane-based therapy and AR-targeted therapy outside of the mCRPC setting is allowed.

Exclusion Criteria: 

  • Prior treatment with a poly (adenosine diphosphate [ADP]-ribose) polymerase (PARP) inhibitor.
  • History or current diagnosis of myelodysplastic syndrome (MDS)/acute myeloid leukemia (AML).
  • Active malignancy (exceptions: adequately treated basal cell or squamous cell skin cancer, superficial bladder cancer, or any other cancer in situ currently remission) less than or equal to (≤) 2 years prior to enrollment.
  • Active infection requiring systemic therapy.
  • Allergies, hypersensitivity, or intolerance to niraparib or the corresponding excipients.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Jacksonville, Fla.

Mayo Clinic principal investigator

Winston Tan, M.D.

Closed for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

More information


Publications are currently not available

Additional contact information

Cancer-related trials contact form

Phone: 855-776-0015 (toll-free)

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