AMPLITUDE
10 Nov 2020
Trial Summary
The purpose of the study is to determine if the combination of niraparib with Abiraterone Acetate (AA) plus prednisone compared with AA plus prednisone in participants with deleterious germline or somatic Homologous Recombination Repair (HRR) gene-mutated Metastatic Castration-Sensitive Prostate Cancer (mCSPC) provides superior efficacy in improving radiographic progression-free survival (rPFS).
Acronym:
AMPLITUDE
ACTRN/NCT /ethics:
NCT04497844
Scientific title:
A Study of Niraparib in Combination With Abiraterone Acetate and Prednisone Versus Abiraterone Acetate and Prednisone for the Treatment of Participants With Deleterious Germline or Somatic Homologous Recombination Repair (HRR) Gene-Mutated Metastatic Castration-Sensitive Prostate Cancer (mCSPC)
Sponsor / Cooperative group:
Janssen Research & Development, LLC
Trial & Patient Characteristics
| Cancer Type | Prostate |
|---|---|
| Trial Type | Treatment |
| Phase | Phase III |
| Age Range | 18 years and older |
| Sex | Male |
| Tumour Stream | - |
| Cancer Stage | Metastatic or Widespread |
| Anticipated Start Date | 2020-09-23 |
| Anticipated End Date | 2024-11-15 |
Participating Hospitals
| Hospital | Icon Cancer Centre Adelaide |
|---|---|
| Clinical Trial Coordinator | Sue Yeend |
| sue.yeend@icon.team | |
| Phone | 08 8292 2204 |
| Principal Investigator | Dr Francis Parnis |
| Recruitment Status | Recruiting |