Talazoparib & Enzalutamide in Treating Metastatic Prostate Cancer
Research type
Research Study
Full title
TALAPRO-2 A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of Talazoparib with Enzalutamide in Metastatic Castration-Resistant Prostate Cancer
IRAS ID
233295
Contact name
Robert John Jones
Contact email
Sponsor organisation
Pfizer Inc., 235 East 42nd Street, New York, NY 10017
Eudract number
2017-003295-31
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
129,642, IND number
Duration of Study in the UK
3 years, 6 months, 27 days
Research summary
Talazoparib in combination with enzalutamide is being investigated for the treatment of metastatic castration-resistant prostate cancer (CRPC).
Talazoparib is an investigational drug. An investigational drug is one that is not approved for sale in UK. Enzalutamide is approved for sale in UK, however its combination with Talazoparib is investigational in this clinical trial. In clinical trials, the use of talazoparib and other compounds having a similar action have shown that these types of drugs can reduce tumour size and slow tumour growth.
This study will collect information on how participant’s prostate cancer responds to the treatment.
Approximately 860 participants will take part.
Enrolled participants will continue to receive treatment or be in the study until tests show that their cancer is getting worse and that they are no longer benefiting from treatment, or side effects become too severe, or they choose to stop receiving treatment.
The study consists of up to 5 periods:
• Pre-screening (optional) and Screening period – to check if you meet the requirements to take part in this study
• Treatment period – you will be assigned a treatment. You will have a 50% chance of receiving either talazoparib or placebo (placebo does not contain any drug). All patients will receive enzalutamide. Placebo will be used to compare with and see whether the study drug works and/or affects patient’s safety.
• Safety follow-up - will occur approximately 28 days after the last dose of study drug or before starting a new drug treatment.
• Long-term follow-up – will follow safety follow-up and consist of body scans to access progression-free survival.
Before any study procedures are undertaken Informed Consent will be required. At scheduled study visits, participants will visit the research centre where study assessments will take place e.g. physical exam, blood tests and body scans. Side effects will be monitored throughout the study.REC name
Wales REC 3
REC reference
19/WA/0010
Date of REC Opinion
27 Feb 2019
REC opinion
Further Information Favourable Opinion