TALAPRO-3 clinical trial protocol: phase III study of talazoparib plus enzalutamide in metastatic castration-sensitive prostate cancer.
| Autor: | Agarwal N; Huntsman Cancer Institute, University of Utah, Salt Lake City, UT 84112, USA., Saad F; University of Montréal Hospital Center, Montréal, Québec, H2L 4M1, Canada., Azad AA; Peter MacCallum Cancer Centre, Melbourne, Victoria, 3000, Australia., Mateo J; Vall d'Hebron Institute of Oncology (VHIO), Vall d'Hebron University Hospital, 08035, Barcelona, Spain., Matsubara N; National Cancer Center Hospital East, Chiba, 277-8577, Japan., Shore ND; Carolina Urologic Research Center, Myrtle Beach, SC 29572, USA., Chakrabarti J; Pfizer Ltd., Tadworth, Surrey, KT20 7NS, UK., Chen HC; Pfizer Inc., La Jolla, CA 92121, USA., Lanzalone S; Pfizer Oncology, Milan, 20152, Italy., Niyazov A; Pfizer Inc., New York, NY, 10012, USA., Fizazi K; Institut Gustave Roussy, University of Paris Sud, Villejuif, 94800, France. |
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| Jazyk: | angličtina |
| Zdroj: | Future oncology (London, England) [Future Oncol] 2024 Mar; Vol. 20 (9), pp. 493-505. Date of Electronic Publication: 2023 Oct 26. |
| DOI: | 10.2217/fon-2023-0526 |
| Abstrakt: | 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. |
| Databáze: | MEDLINE |
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