Hannah Clarke

Eligible patients will receive UGN-103 75 mg intravesically once per week for 6 weeks.

The data, collected as part of the phase 1/2 Duravelo-1 trial, showed an objective response rate of 65%.

The application is supported by data from the phase 3 AMPLITUDE trial.

Take a look through all the regulatory milestones in urology from the first half of the 2025.

Here’s a look back at notable news between April and June 2025.

The da Vinci 5 platform is approved for use across urologic, gynecologic, and general laparoscopic procedures in adult and pediatric patients.

The study will utilize the companion lipid biomarker test, PCPro, to identify patients who may benefit from the addition of opaganib to darolutamide.

The trial is evaluating the efficacy of leflutrozole in improving testicular function and promoting spermatogenesis.

The combination demonstrated a 6-month radiographic progression-free survival of 66%.

A recap of the FDA submissions and regulatory decisions in urology from June 2025.

Justin Dubin, MD, touches on the current landscape of men’s health, with a specific focus on the advent of AI.

The TOBY test works by analyzing the molecular signatures of volatile organic compounds in urine.

The primary end point for the trial is the complete response rate at 3 months.

A comprehensive guide to the key regulatory decisions and conferences slated for Q3 of 2025.

The study also found racial differences in the time to proceeding with surgical therapy.

The unfortunate news of President Biden’s diagnosis has put a spotlight on prostate cancer, offering an opportunity to educate on the risks of the disease and the benefits of screening.

The test utilizes chromosomal instability signatures to predict resistance to taxane-based chemotherapy in metastatic prostate cancer.

The results demonstrated a favorable ratio between radiation doses absorbed in the tumor vs the doses delivered to key healthy organs.

Oral sulopenem was approved by the FDA in October 2024 for the management of uUTIs.

Detalimogene is currently under evaluation in the pivotal phase 1/2 LEGEND trial.

Arm D of the trial is assessing the performance of [68Ga]Ga-DPI-4452 in detecting ccRCC in patients with an indeterminate renal mass.

The label expansion follows the FDA approval of an expanded label for 177Lu-PSMA-617 for use in patients with mCRPC after ARPI therapy and before chemotherapy.

The phase 1 study is set to begin later this year.

The approval is supported by data from the pivotal phase 3 ARANOTE trial.

The approval is supported by several studies highlighting the efficacy of Rezūm Water Vapor Therapy in patients with larger prostates.

"Overall, these findings add to the growing body of evidence that [shows that] apalutamide may offer a survival advantage in real-world setting in patients with metastatic castration-sensitive prostate cancer," says Mehmet A. Bilen, MD.

The IDeate-Prostate01 trial plans to enroll approximately 1440 patients whose tumors progressed following prior treatment with an ARPI.

The approval is supported by landmark results from the pivotal phase 2 SANS-UUI trial.

ArteraAI is a multimodal artificial intelligence biomarker test that can predict therapy benefit and prognosticate long-term outcomes in prostate cancer.

Pfizer has chosen to no longer pursue an expanded indication for talazoparib plus enzalutamide in non-HRR gene mutated mCRPC in the US as a result of this decision.