A Multi-Center Trial of Androgen Suppression With Abiraterone Acetate, Leuprolide, PARP Inhibition and Stereotactic Body Radiotherapy in Prostate Cancer

Part of paid clinical trials in Ann Arbor, Michigan.

Sponsor
University of Michigan Rogel Cancer Center
Study ID
NCT04194554
Phase
PHASE1/PHASE2
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
MALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Niraparib — DRUG
    given PO per dose escalation schedule
  • Leuprolide — DRUG
    22.5 mg q3 month
  • Abiraterone Acetate — DRUG
    1000 mg daily
  • Stereotactic body radiotherapy (SBRT) — RADIATION
    5-6 fraction SBRT (total dose: 37.5-40 Gy)

Study Details

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).

Key Dates

Start date
Nov 6, 2020
Status verified
Apr 2026
Primary completion
May 31, 2027
Completion
May 31, 2029

Study Design

Enrollment
102 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Niraparid Dose Escalation
    Dose Level 1: 100 mg PO daily of Niraparib but held for 5 days (+/- 2 days) prior to RT, during SBRT, and 5 days (+/- 2 days) after last fraction of SBRT Dose Level 2: 200 mg PO daily of Niraparib but held for 5 days (+/- 2 days) prior to RT, during SBRT, and 5 days (+/- 2 days) after last fraction of SBRT Dose Level 3: 200 mg PO daily of Niraparib without breaks during SBRT until completion of 6 cycles.

Primary Outcome Measure

Dose-limiting toxicities (Phase 1) [ Time Frame: Up to 112 days after initial dose of niraparib ]

Locations (6)

FacilityCityStateZIPSite coordinators
University of Michigan Rogel Cancer CenterAnn ArborMichigan48109-
Mayo ClinicRochesterMinnesota55901-
Cornell UniversityNew YorkNew York10065-
Weill Cornell MedicineNew YorkNew York10065-
University Hospitals Seidman Cancer CenterClevelandOhio44106-
University of Texas SouthwesternDallasTexas75390-

Find similar trials in Ann Arbor, MI

By condition
Prostate cancer
By specialty
OncologyProstate oncologyMen's healthUrology
By research site
University of Michigan Rogel Cancer Center· Ann Arbor, MIMayo Clinic· Rochester, MNCornell University· New York, NYWeill Cornell Medicine· New York, NYUniversity Hospitals Seidman Cancer Center· Cleveland, OHUniversity of Texas Southwestern· Dallas, TX

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