Treatment with darolutamide was found to extend median time to deterioration of FACT-P total score by 5.1 months vs placebo

“This was a positive study, resulting in a statistically significant improvement in the primary end point of rPFS in the intent-to-treat population," said Rana R. McKay, MD, FASCO.

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

According to the authors, these data continue to support enzalutamide plus ADT as a standard-of-care for patients with mHSPC.

"CAN-2409 immunotherapy could represent the first new therapy for men with localized prostate cancer in over 20 years," wrote the authors.

Clinical benefit rate was observed 5 (27%) patients in cohort 1, 7 (27%) patients in cohort 2, and 2 (11%) patients in cohort 3.

“As of April 2025, 616 patients have been randomized,” said Alicia Morgans, MD, MPH.

Data also showed a positive trend in overall survival.

Lower-dose abiraterone acetate was found to demonstrate comparable efficacy to standard-dose abiraterone.

“Prior taxanes did not increase reported hematological adverse events during treatment with Ra-223,” the investigators reported.

Results of an exclusive Urology Times survey point to urologists preferring intravesical chemotherapy for treating BCG-unresponsive NMIBC.

“On the intention-to-treat efficacy analysis...the median PFS was numerically higher for the paclitaxel arm," said Aditya Dhanawat, MBBS, MD, DM.

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

The findings also lend further credence to the muscle-invasive bladder cancer treatment regimen, investigators reported.

"This final analysis of this study continues to support nivo+ipi as a standard of care for patients with untreated RCC," says Robert J. Motzer, MD.

"The pre-specified thresholds for statistical significance were not met for the dual primary end points of overall survival in cisplatin-ineligible and PD-L1 positive patients," said Michiel Van der Heijden, MD, PhD.

According to the authors, these data reinforce EV plus pembrolizumab as the first-line standard of care for la/mUC.

"These long-term results continue to support [pembrolizumab's] use as a standard of care for patients at increased risk of recurrence," says Naomi B. Haas, MD.

"There was activity across all the groups from an EFS perspective," said Thomas B. Powles, MBBS, MRCP, MD.

The cCR rate was 44.4% in the intent-to-treat population.

Vitaly Margulis, MD, reported an overall response rate of 86.5%, and a complete response rate of 73%.

The addition of Ra223 to enzalutamide was associated with a 31% reduction in the risk of progression or death compared with enzalutamide alone.

The trial plans to enroll approximately 70 patients with mCRPC.

Campbell emphasized that although gender representation in medicine is shifting, structural and cultural biases continue to influence academic recognition.