TALAPRO-3 clinical trial protocol: phase III study of talazoparib plus enzalutamide in metastatic castration-sensitive prostate cancer.
Future Oncol
; 20(9): 493-505, 2024 Mar.
Article
in En
| MEDLINE
| ID: mdl-37882449
ABSTRACT
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 RegistrationNCT04821622 (ClinicalTrials.gov) Registry Name Study of Talazoparib With Enzalutamide in Men With DDR Gene Mutated mCSPC. Date of Registration 29 March 2021.
Key words
Full text:
1
Collection:
01-internacional
Database:
MEDLINE
Main subject:
Phenylthiohydantoin
/
Phthalazines
/
Benzamides
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Prostatic Neoplasms, Castration-Resistant
Limits:
Humans
/
Male
Language:
En
Journal:
Future Oncol
Year:
2024
Document type:
Article
Affiliation country:
United States