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oai:recercat.cat:11351/112522024-12-24T05:23:10Zcom_2072_378070com_2072_378040col_2072_378092

TALAPRO-3 clinical trial protocol: phase III study of talazoparib plus enzalutamide in metastatic castration-sensitive prostate cancer Matsubara, Nobuaki Agarwal, Neeraj Saad, Fred Azad, Arun Shore, Neal Mateo, Joaquin Institut Català de la Salut [Agarwal N] Huntsman Cancer Institute, University of Utah, Salt Lake City, UT, USA. [Saad F] University of Montréal Hospital Center, Montréal, Québec, Canada. [Azad AA] Peter MacCallum Cancer Centre, Melbourne, Victoria, Australia. [Mateo J] Vall d’Hebron Institute of Oncology (VHIO), Barcelona, Spain. Vall d’Hebron Hospital Universitari, Barcelona, Spain. [Matsubara N] National Cancer Center Hospital East, Chiba, Japan. [Shore ND] Carolina Urologic Research Center, Myrtle Beach, SC, USA Vall d'Hebron Barcelona Hospital Campus Pròstata - Càncer - Tractament Metàstasi Antiandrògens - Receptors DISEASES::Neoplasms::Neoplasms by Site::Urogenital Neoplasms::Genital Neoplasms, Male::Prostatic Neoplasms CHEMICALS AND DRUGS::Chemical Actions and Uses::Pharmacologic Actions::Physiological Effects of Drugs::Hormones, Hormone Substitutes, and Hormone Antagonists::Hormone Antagonists::Androgen Antagonists::Androgen Receptor Antagonists ANALYTICAL, DIAGNOSTIC AND THERAPEUTIC TECHNIQUES, AND EQUIPMENT::Therapeutics::Therapeutics::Drug Therapy::Antineoplastic Protocols::Therapeutics::Drug Therapy::Antineoplastic Combined Chemotherapy Protocols DISEASES::Neoplasms::Neoplastic Processes::Neoplasm Metastasis ENFERMEDADES::neoplasias::neoplasias por localización::neoplasias urogenitales::neoplasias de los genitales masculinos::neoplasias de la próstata COMPUESTOS QUÍMICOS Y DROGAS::acciones y usos químicos::acciones farmacológicas::efectos fisiológicos de los fármacos::hormonas, sustitutos de hormonas y antagonistas de hormonas::antagonistas de hormonas::antagonistas de andrógenos::antagonistas de receptores de andrógenos TÉCNICAS Y EQUIPOS ANALÍTICOS, DIAGNÓSTICOS Y TERAPÉUTICOS::terapéutica::terapéutica::farmacoterapia::protocolos antineoplásicos::terapéutica::farmacoterapia::protocolos de quimioterapia antineoplásica combinada ENFERMEDADES::neoplasias::procesos neoplásicos::metástasis neoplásica PARP inhibitor; Androgen receptor; Enzalutamide Inhibidor de PARP; Receptor de andrógenos; Enzalutamida Inhibidor de PARP; Receptor d'andrògens; Enzalutamida Poly(ADP-ribose) polymerase 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. This study was sponsored by Pfizer. Astellas Pharma Inc. provided enzalutamide. 2024-03-27T08:57:30Z 2024-03-27T08:57:30Z 2023-10-26 info:eu-repo/semantics/article info:eu-repo/semantics/publishedVersion Agarwal N, Saad F, Azad AA, Mateo J, Matsubara N, Shore ND, et al. TALAPRO-3 clinical trial protocol: phase III study of talazoparib plus enzalutamide in metastatic castration-sensitive prostate cancer. Futur Oncol. 2023 Oct 26;20(9):493–505. 1479-6694 https://hdl.handle.net/11351/11252 10.2217/fon-2023-0526 37882449 001087207700001 eng Future Oncology;20(9) https://doi.org/10.2217/fon-2023-0526 Attribution-NonCommercial-NoDerivatives 4.0 International http://creativecommons.org/licenses/by-nc-nd/4.0/ info:eu-repo/semantics/openAccess application/pdf Future Medicine Scientia