AMPLITUDE
Research type
Research Study
Full title
A Phase 3 Randomized, Placebo-controlled, Double-blind 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)
IRAS ID
286545
Contact name
Gerhardt Attard
Contact email
Sponsor organisation
Janssen-Cilag International NV
Eudract number
2020-002209-25
Duration of Study in the UK
4 years, 1 months, 1 days
Research summary
Prostate cancer is the second most common cancer in men worldwide. For patients who develop metastatic disease (i.e. their cancer spreads from the prostate) the 5-year survival rate is only 30%. The purpose of this study is to see whether niraparib, a type of drug called a PARP inhibitor, could be used in addition to a standard treatment (abiraterone acetate and prednisone) to treat men with metastatic prostate cancer who also have specific genetic changes. Niraparib is approved to treat some types of cancer but has not yet been approved for prostate cancer.
Participants tumour and blood or saliva samples will be assessed during the Pre-Screening Phase to identify whether they have deleterious (i.e. harmful) germline or somatic homologous recombination repair (HRR) gene mutations. Only those participants with confirmed mutations will be eligible to consent into the main part of the study. This consists of a Screening Phase of up to 28 days, following which participants will be randomly assigned (randomised) equally to one of two groups, and will then receive either niraparib, abiraterone acetate and prednisone or abiraterone acetate and prednisone alone. Placebos will also be used to allow blinded comparisons between the study treatments. The Treatment Phase of the study comprises treatment cycles of 28-days. The Follow-up Phase, which includes a visit/phonecall every 4 months, will continue until death, loss to follow-up, withdrawal of consent, or study termination, whichever occurs first.
REC name
East Midlands - Leicester Central Research Ethics Committee
REC reference
20/EM/0209
Date of REC Opinion
12 Oct 2020
REC opinion
Further Information Favourable Opinion