PARP inhibitors in combination with androgen receptor-targeted therapy have demonstrated potential in the treatment of metastatic castration-resistant prostate cancer (mCRPC). Here, we describe the design and rationale of the multinational, Phase III, two-part TALAPRO-2 study comparing talazoparib plus enzalutamide versus placebo plus enzalutamide as a first-line treatment for patients with mCRPC with or without DNA damage response (DDR) alterations. This study has two co-primary end points: radiographic progression-free survival (rPFS) by blinded independent clinical review in all-comers (Cohort 1) and in patients with DDR alterations (Cohort 2). TALAPRO-2 will demonstrate whether talazoparib plus enzalutamide can significantly improve the efficacy of enzalutamide in terms of rPFS in both molecularly unselected and DDR-deficient patients with mCRPC (NCT03395197). Clinical Trial Registration: NCT03395197 (ClinicalTrials.gov).
Future oncology (London, England). 2022 Jan 26 [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), University of Utah, Salt Lake City, UT 84112, USA., Department of Medical Oncology, Peter MacCallum Cancer Centre, Melbourne, VIC 3000, Australia., Department of Urology, Carolina Urologic Research Center, Myrtle Beach, SC 29572, USA., Vall d'Hebron University Hospital, Vall d'Hebron Institute of Oncology (VHIO), Barcelona 08035, Spain., PUCRS School of Medicine Grupo Oncoclínicas, Porto Alegre 90610-000, Brazil., Urological Associates of Southern Arizona, Tucson, AZ 85741, USA., The Urology Center of Colorado, Denver, CO 80211, USA., Pfizer Inc., Global Product Development, Groton, CT 06340, USA., Pfizer Inc., Global Product Development, Durham, NC 27707, USA., Pfizer Inc., Global Product Development, La Jolla, 92121 CA, USA., Pfizer Inc., Cambridge, MA, USA., Department of Cancer Medicine, Institut Gustave Roussy, University of Paris Saclay, Villejuif 94800, France.