NCT04194554

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

A Multi-Center Trial of Androgen Suppression With Abiraterone aCetate, LEuprolide, PARP Inhibition and Stereotactic Body Radiotherapy (ASCLEPIuS): A Phase I/2 Trial in High Risk and Node Positive Prostate Cancer

• Status: Active Not Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 102 (actual)
• Sponsor: University of Michigan Rogel Cancer Center · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Prostate Cancer

Interventions

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

Timeline

• Start date: 2020-11-06
• Primary completion: 2026-11-01
• Completion: 2027-05-01
• First posted: 2019-12-11
• Last updated: 2025-06-04

Locations

6 sites across 1 country: United States

Regulatory

• FDA-regulated drug study
• FDA-regulated device study