TALAPRO-3 clinical trial protocol: phase III study of talazoparib plus enzalutamide in metastatic castration-sensitive prostate cancer.

Poly(ADP-ribose) polymerase (PARP) inhibitors in combination with androgen-receptor signaling inhibitors are a promising therapeutic option for patients with metastatic castration-sensitive prostate cancer (mCSPC) and homologous recombination repair (HRR) gene alterations.

Here, we describe the design and rationale of the multinational, phase III, TALAPRO-3 study comparing talazoparib plus enzalutamide versus placebo plus enzalutamide in patients with mCSPC and HRR gene alterations. The primary end point is investigator-assessed radiographic progression-free survival (rPFS) per RECIST 1.1 in soft tissue, or per PCWG3 criteria in bone. The TALAPRO-3 study will demonstrate whether the addition of talazoparib can improve the efficacy of enzalutamide as assessed by rPFS in patients with mCSPC and HRR gene alterations undergoing androgen deprivation therapy. Clinical Trial Registration:NCT04821622 (ClinicalTrials.gov) Registry Name: Study of Talazoparib With Enzalutamide in Men With DDR Gene Mutated mCSPC. Date of Registration: 29 March 2021.

Future oncology (London, England). 2023 Oct 26 [Epub ahead of print]

Neeraj Agarwal, Fred Saad, Arun A Azad, Joaquin Mateo, Nobuaki Matsubara, Neal D Shore, Jayeta Chakrabarti, Hsiang-Chun Chen, Silvana Lanzalone, Alexander Niyazov, Karim Fizazi

Huntsman Cancer Institute, University of Utah, Salt Lake City, UT 84112, USA., University of Montréal Hospital Center, Montréal, Québec, H2L 4M1, Canada., Peter MacCallum Cancer Centre, Melbourne, Victoria, 3000, Australia., Vall d'Hebron Institute of Oncology (VHIO), Vall d'Hebron University Hospital, 08035, Barcelona, Spain., National Cancer Center Hospital East, Chiba, 277-8577, Japan., Carolina Urologic Research Center, Myrtle Beach, SC 29572, USA., Pfizer Ltd., Tadworth, Surrey, KT20 7NS, UK., Pfizer Inc., La Jolla, CA 92121, USA., Pfizer Oncology, Milan, 20152, Italy., Pfizer Inc., New York, NY, 10012, USA., Institut Gustave Roussy, University of Paris Sud, Villejuif, 94800, France.