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Plain language summary of the design of the TALAPRO-2 study comparing talazoparib and enzalutamide versus enzalutamide and placebo in men with metastatic castration-resistant prostate cancer Carles Galceran, Joan Fay, Andre P Shore, Neal Agarwal, Neeraj Azad, Arun Dunshee, Curtis Institut Català de la Salut [Agarwal N] Huntsman Cancer Institute (NCI-CCC) at the University of Utah, Salt Lake City, UT, USA. [Azad A] Peter MacCallum Cancer Centre, Melbourne, Australia. [Shore ND] Carolina Urologic Research Center, Myrtle Beach, SC, USA. [Carles J] Vall d’Hebron Institute of Oncology (VHIO), Barcelona, Spain. Vall d’Hebron Hospital Universitari, Barcelona, Spain. [Fay AP] PUCRS School of Medicine Grupo Oncoclínicas, Porto Alegre, Brazil. [Dunshee C] Urological Associates of Southern Arizona, Tucson, AZ, USA Vall d'Hebron Barcelona Hospital Campus Pròstata - Càncer - Tractament Medicaments antineoplàstics - Ús terapèutic DISEASES::Neoplasms::Neoplasms by Site::Urogenital Neoplasms::Genital Neoplasms, Male::Prostatic Neoplasms::Prostatic Neoplasms, Castration-Resistant ANALYTICAL, DIAGNOSTIC AND THERAPEUTIC TECHNIQUES, AND EQUIPMENT::Therapeutics::Therapeutics::Drug Therapy::Antineoplastic Protocols::Therapeutics::Drug Therapy::Antineoplastic Combined Chemotherapy Protocols Other subheadings::Other subheadings::/therapeutic use ENFERMEDADES::neoplasias::neoplasias por localización::neoplasias urogenitales::neoplasias de los genitales masculinos::neoplasias de la próstata::neoplasias prostáticas resistentes a la castración TÉCNICAS Y EQUIPOS ANALÍTICOS, DIAGNÓSTICOS Y TERAPÉUTICOS::terapéutica::terapéutica::farmacoterapia::protocolos antineoplásicos::terapéutica::farmacoterapia::protocolos de quimioterapia antineoplásica combinada Otros calificadores::Otros calificadores::/uso terapéutico Clinical trial; Enzalutamide; Talazoparib Ensayo clínico; Enzalutamida; Talazoparib Assaig clínic; Enzalutamida; Talazoparib What is this summary about? 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. What is metastatic castration-resistant prostate cancer? 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. Which medicines are being tested? 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. What are the aims of the TALAPRO-2 trial? 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) 2022-12-13T10:17:05Z 2022-12-13T10:17:05Z 2022-09 info:eu-repo/semantics/article info:eu-repo/semantics/publishedVersion Agarwal N, Azad A, Shore ND, Carles J, Fay AP, Dunshee C, et al. Plain language summary of the design of the TALAPRO-2 study comparing talazoparib and enzalutamide versus enzalutamide and placebo in men with metastatic castration-resistant prostate cancer. Future Oncol. 2022 Sep;18(27):2979–86. 1744-8301 https://hdl.handle.net/11351/8661 10.2217/fon-2022-0389 35950899 000838720900001 http://hdl.handle.net/11351/8661 eng Future Oncology;18(27) https://doi.org/10.2217/fon-2022-0389 Attribution-NonCommercial-NoDerivatives 4.0 International http://creativecommons.org/licenses/by-nc-nd/4.0/ info:eu-repo/semantics/openAccess application/pdf Future Science Group Scientia