drugset / Trial / NCT04194554
A Multi-Center Trial of Androgen Suppression With Abiraterone Acetate, Leuprolide, PARP Inhibition and Stereotactic Body Radiotherapy in Prostate Cancer
Phase 1/2
Active not recruiting
102 enrolled
University of Michigan Rogel Cancer Center
Janssen Scientific Affairs, LLC · collab
NaSingle-groupOpen-labelTreatment
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).
Timeline
- Start
- 2020-11-06
- Primary completion
- 2027-05
- Completion
- 2029-05
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Niraparib | Small molecule | 100 mg | Oral |
| Subject | Niraparib | Small molecule | 200 mg | Oral |
| Background | Abiraterone acetate | Small molecule | 1000 mg | — |
| Background | Leuprolide | Other / unclassified | 22.5 mg | — |