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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 TypeProstate
Trial TypeTreatment
PhasePhase III
Age Range18 years and older
SexMale
Tumour Stream -
Cancer StageMetastatic or Widespread
Anticipated Start Date2020-10-01
Anticipated End Date2027-05-07

Participating Hospitals

HospitalAshford Cancer Centre Research
Clinical Trial CoordinatorSue Yeend
Emailsyeend@adelaidecancercentre.com.au
Phone08 8292 2240
Principal InvestigatorDr Francis Parnis
Recruitment StatusNot Yet Recruiting