Urology Times

07/21/2025

The European Commission has approved the combination of darolutamide plus ADT for the treatment of patients with mHSPC.

This approval enables the use of darolutamide plus ADT with or without chemotherapy.

07/21/2025

Patients with LG-IR-NMIBC who achieved a CR after treatment with mitomycin for intravesical solution experienced a clinically meaningful long-term durable response, according to data from an extension study of the OPTIMA II trial.

Mitomycin intravesical solution was granted FDA approval in June 2025 for recurrent LG-IR-NMIBC.

07/18/2025

The enrollment goal has been met in the Co-PSMA trial, comparing the performance of 64Cu-SAR-bisPSMA vs 68Ga-PSMA-11 PET/CT in detecting prostate cancer recurrence.

The phase 2 Co-PSMA trial enrolled 50 patients with biochemical recurrence of prostate cancer.

07/17/2025

The FDA and the French ANSM have granted clearance to a pivotal trial of the UroActive smart implant for male stress urinary incontinence.

The SOPHIA2 trial will assess the safety and efficacy of the UroActive implant in men with SUI.

07/17/2025

The FDA has granted priority review to a new drug application for TAR-200 in BCG-unresponsive high-risk NMIBC.

The new drug application for TAR-200 is supported by data from cohort 2 of the phase 2b SunRISe-1 trial.

07/16/2025

The Bladder Cancer Advocacy Network has announced the launch of a $1 million Continuity Grant to provide support for bladder cancer research projects that have been impacted by terminations in federal funding.

The Continuity Grant will support projects in bladder cancer and/or upper tract urothelial carcinoma that were previously scientifically reviewed, approved, and funded.

07/16/2025

Hamlet BioPharma recently announced the successful completion of an in-person meeting with the FDA, paving the way for initiation of a pivotal phase 3 trial of Alpha1H in patients with NMIBC.

Alpha1H was granted a fast track designation in November 2023.

07/16/2025

Watch🎥: Ziho Lee, MD, previews Northwestern's GU robotic reconstruction course, which will take place on August 2, 2025.

The course addresses "unicorn cases" in the upper tract—unique and challenging situations lacking established guidelines or literature.

07/16/2025

Slow Adoption of New NMIBC Treatments: What’s Holding Urologists Back?

A new Urology Times® survey shows that many urologists continue to rely on intravesical chemotherapy over emerging treatments for BCG-unresponsive non–muscle invasive bladder cancer (NMIBC). Despite encouraging clinical data, uptake of novel therapies remains limited.

The article features expert insights from Dr. Michael S. Cookson and Dr. Jason M. Hafron on why the shift has been slow and what challenges remain in adopting new options in clinical practice.

Read the full article and survey findings here:
https://hubs.li/Q03wvwqt0

07/16/2025

Metastatic and high-risk prostate cancer require thoughtful treatment decisions that go beyond the diagnosis.

In our latest video, Dr. Aaron Berger discusses two patient cases—a 74-year-old with metastatic castration-resistant prostate cancer and a 62-year-old with high-risk localized prostate cancer. He highlights how different formulations of abiraterone acetate can be tailored to improve patient compliance, especially considering fasting requirements.

Patient-centered. Evidence-based. Practical guidance.

Watch now to better understand how to personalize prostate cancer treatment for optimal outcomes.
https://hubs.ly/Q03xjSqJ0

07/15/2025

Metastatic hormone-sensitive prostate cancer (mHSPC) is more than a diagnosis—it’s a complex journey shaped by every treatment decision.

In our new 10-episode video series on Urology Times®, Dr. Paul E. Dato explores the real-world challenges of managing mHSPC. Through patient cases and expert insight, he breaks down key decisions—from therapy selection and genetic testing to formulation differences and supportive care.

Real cases. Real decisions. Real impact.

Watch the full series now to gain a deeper understanding of how to personalize and optimize mHSPC treatment.
https://hubs.ly/Q03xjTGR0

07/15/2025

In the most recent episode of Pearls & Perspectives, host Amy Pearlman, MD, sits down with John P. Mulhall, MD, to discuss testosterone and the future of men’s health.

Mulhall offers an unfiltered, evidence-based deep dive into testosterone evaluation and treatment nuances.