Topline results from the study are anticipated in the first half of 2027.
Feature|Articles|September 1, 2025
FDA updates in urology: August 2025
Author(s)Hannah Clarke
Fact checked by: Benjamin P. Saylor, Strategic Content Lead
A recap of the FDA submissions and regulatory decisions in urology from August 2025.
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Welcome to Urology Times’® monthly FDA update! August ushered in several notable advancements, with a particular focus in prostate cancer. Specifically, key developments included regulatory approval of an artificial intelligence (AI)-based test, acceptance of an application for a new formulation of a prostate-specific membrane antigen (PSMA)-PET imaging agent, and approval of a new formulation of a drug for advanced prostate cancer.
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JNJ-6143 demonstrated promising PSA and tumor response rates with an encouraging safety profile in heavily pretreated mCRPC, including across genomic subgroups.
Alberto Briganti, MD, PhD, discusses results from the PROTEUS substudy, evaluating perioperative apalutamide plus ADT vs surgery alone in high-risk localized or locally advanced prostate cancer.
Updated CAPItello-281 data showed a clinically meaningful benefit in OS when capivasertib was added to abiraterone and ADT in PTEN-deficient mHSPC.
In TALAPRO-3, talazoparib plus enzalutamide improved rPFS vs placebo plus enzalutamide (HR, 0.48; P < .0001) in HRR-mutated mAPMN/S prostate cancer.
Interim phase 3 data show a 58% reduction in the risk of metastasis or death with the addition of darolutamide to ADT + radiation.
Carlos A. Vargas, MD, discusses updated survival outcomes, safety, and the mechanism of SYNC-T SV-102, an investigational in situ immunotherapy for metastatic prostate cancer.
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