The purpose of this study is to establish the maximum tolerable dose of niraparib when combined with prostate stereotactic body radiotherapy (SBRT), abiraterone, leuprolide, and prednisone (the phase 1 portion of the study) and determine 3-year biochemical PSA recurrence free-survival with this treatment approach (the phase 2 portion of the study).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
102
University of Michigan Rogel Cancer Center
Ann Arbor, Michigan, United States
Mayo Clinic
Rochester, Minnesota, United States
Cornell University
New York, New York, United States
Weill Cornell Medicine
New York, New York, United States
Dose-limiting toxicities (Phase 1)
The proportion of patients at each dose level with dose-limiting toxicity (DLT), defined as any treatment related grade 3-5 adverse event experienced within the first 4 treatment cycles (112 days), assessed per NCI's CTCAE version 5.0.
Time frame: Up to 112 days after initial dose of niraparib
Proportion of patients experiencing biochemical failure
Change in PSA level from the beginning of study treatment for up to 3 years later will determine the biochemical failure rate. Biochemical failure will be defined using the Phoenix definition of the PSA nadir + 2 ng/mL.
Time frame: Up to 3 years after first dose of niraparib
Change in health related quality of life
Assessed via EPIC-26 questionnaire
Time frame: From baseline up to 3 years after last dose of niraparib
Proportion of patients with undetectable post-treatment PSA
Undetectable PSA will be defined as a PSA ≤0.1 ng/mL.
Time frame: Measured during the end of the 6th cycle of therapy (during week 24 +/- 7 days)
Proportion of patients with distant metastases
Distant metastases will be defined as any clinical or radiographic evidence of lymph node, bone, or visceral involvement of prostate cancer.
Time frame: Up to 5 years after first dose of niraparib
Prostate cancer specific survival
Prostate cancer specific survival will be defined as the duration of time from the start of treatment to death attributable to prostate cancer. Patients who have not died or die of non-prostate cancer related causes will be censored at the last known follow-up or date of death, respectively. Summarized using cumulative incidence or Kaplan-Meier curves as appropriate.
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5-6 fraction SBRT (total dose: 37.5-40 Gy)
University Hospitals Seidman Cancer Center
Cleveland, Ohio, United States
University of Texas Southwestern
Dallas, Texas, United States
Time frame: Up to 5 years after first dose of niraparib
Overall survival
Overall survival (OS) will be defined as the duration of time from the start of treatment to death from any cause. Patients who have not died will be censored at the last known follow-up.Summarized using cumulative incidence or Kaplan-Meier curves as appropriate.
Time frame: Up to 5 years after first dose of niraparib