Clinical Trial

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

Study acronym: ASCLEPIuS
Active, Not Recruiting Phase 1/2
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Summary
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).
Protocol Amendment History 13 amendments
This ClinicalTrials.gov record has been amended 13 times since 2019-12-09; most recent amendment 2026-04-30.
Status change: Recruiting → Active, Not Recruiting 2024-09-24
Status change: Not Yet Recruiting → Recruiting 2020-07-29
Trial Details
NCT Number NCT04194554
Lead Sponsor University of Michigan Rogel Cancer Center
Collaborators: Janssen Scientific Affairs, LLC
Conditions Prostate Cancer
Enrollment 102 participants
Start Date 2020-11-06
Primary Completion 2027-05 (estimated)
Study Completion 2029-05 (estimated)
Updated on ClinicalTrials.gov 2026-05-01