Research of Talazoparib & Enzalutamide in Men with Gene Mutated mCSPC
Research type
Research Study
Full title
TALAPRO-3: A Phase 3, Randomized, Double-Blind, Study Of Talazoparib With Enzalutamide Versus Placebo With Enzalutamide In Men With DDR Gene Mutated Metastatic Castration-Sensitive Prostate Cancer
IRAS ID
297323
Contact name
Alison Birtle
Contact email
Sponsor organisation
Pfizer Inc.
Eudract number
2021-000248-23
ISRCTN Number
ISRCTN00000000
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
129,642, US IND Number; TALAPRO-3, Acronym
Duration of Study in the UK
5 years, 5 months, 13 days
Research summary
The purpose of this study is to evaluate the safety and efficacy of talazoparib or placebo (a pretend drug) in combination with enzalutamide in patients with metastatic castration-sensitive prostate cancer (mCSPC). Talazoparib may reduce the tumour size and slow its growth in patients with defects in genes that are important for DNA repair.
The study will be conducted at 240 sites in 29 countries, and 550 men will take part for about 3 years. Half of the patients will receive the study drug talazoparib and enzalutamide, the rest will receive placebo and enzalutamide randomly like the toss of a coin. Participants will be asked to sign an informed consent form before any study procedures are performed to check if they meet the requirements to take part in this study. If they are enrolled, they will need to visit the research site at least 16 times during the study.
During the treatment period participants will have 1 in 2 chance of receiving either talazoparib or placebo. No one (including participant and the study team) can choose the group the participant will be assigned to. Placebo will be used to see whether the study drug works and affects patient safety. All patients will receive enzalutamide. The study medications, provided as capsules in a childproof package, will be swallowed whole, with a large glass of water at approximately the same time every day. Participants will be evaluated for safety and efficacy, with radiologic progression free survival as primary study endpoint. Other efficacy endpoints, Patient reported outcomes and biomarker endpoints are also evaluated.
Safety follow-up visit will occur about 28 days after the last dose of the study drug or before the start of new drug treatment. Long-term follow-up will include scans and blood tests to assess survival status and whether the disease progresses.REC name
East Midlands - Nottingham 2 Research Ethics Committee
REC reference
21/EM/0158
Date of REC Opinion
13 Aug 2021
REC opinion
Further Information Favourable Opinion