This summary describes the design of an ongoing research study (also known as a clinical trial) called TALAPRO-2. The TALAPRO-2 trial is testing the combination of two medicines called talazoparib and enzalutamide as a first treatment in adult men with metastatic castration-resistant prostate cancer.
The study began in December 2017 and has enrolled 1037 adult men with metastatic castration-resistant prostate cancer from 26 countries.
Metastatic castration-resistant prostate cancer is a type of cancer that has advanced beyond the prostate and continues to grow even when testosterone levels in the blood are suppressed.
The combination of talazoparib plus enzalutamide will be compared with enzalutamide plus placebo. Enzalutamide is approved to treat men with prostate cancer. Talazoparib is not approved to treat men with prostate cancer. A placebo does not contain any active ingredients and is also known as a sugar pill.
The TALAPRO-2 trial will find out if combining talazoparib with enzalutamide increases the length of time the men in the study live without their cancer getting worse compared with enzalutamide plus placebo. The study will also measure how long men in the study live and any side effects the men have while they are taking the study medicines. Researchers are also testing the DNA from the tumor cells of all men in the study to find out if they have faulty DNA repair genes. Clinical Trial Registration: NCT0339519 (ClinicalTrials.gov).
Future oncology (London, England). 2022 Aug 11 [Epub ahead of print]
Neeraj Agarwal, Arun Azad, Neal D Shore, Joan Carles, Andre P Fay, Curtis Dunshee, Lawrence Ivan Karsh, Maria Luisa Paccagnella, Nicola Di Santo, Mohamed Elmeliegy, Xun Lin, Akos Czibere, Karim Fizazi
Huntsman Cancer Institute (NCI-CCC) at the University of Utah, Salt Lake City, UT, USA., Peter MacCallum Cancer Centre, Melbourne, Australia., Carolina Urologic Research Center, Myrtle Beach, SC, USA., Vall d'Hebron Institute of Oncology, Vall d'Hebron University Hospital, Barcelona, Spain., PUCRS School of Medicine Grupo Oncoclínicas, Porto Alegre, Brazil., Urological Associates of Southern Arizona, Tucson, AZ, USA., The Urology Center of Colorado, Denver, CO, USA., Pfizer Inc., Groton, CT, USA., Pfizer Inc., Durham, NC, USA., Pfizer Inc., La Jolla, CA, USA., Pfizer Inc., Cambridge, MA, USA., Institut Gustave Roussy, University of Paris-Saclay, Villejuif, France.