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

Other authors

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

Publication date

2024-03-27T08:57:30Z

2024-03-27T08:57:30Z

2023-10-26

Abstract

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.

Document Type

Article


Published version

Language

English

Subjects and keywords

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

Publisher

Future Medicine

Related items

Future Oncology;20(9)

https://doi.org/10.2217/fon-2023-0526

Recommended citation

This citation was generated automatically.

Rights

Attribution-NonCommercial-NoDerivatives 4.0 International

http://creativecommons.org/licenses/by-nc-nd/4.0/

This item appears in the following Collection(s)