Benjamin P. Saylor

The data come just days after the FDA approved IsoPSA to aid in the diagnosis of high-grade prostate cancer.

For micro-ultrasound compared with true cancer status, estimated sensitivity was 0.8000.

The HCPs and AHCPs described insertion and removal of the system to be “straightforward” and done in less than 5 minutes.

At a median follow-up of 25.8 months, the CR rate at any time was 75.5%.

The investigators reported that new onset of CNS-related conditions was lower in patients in the apalutamide cohort at 12 months and 24 months post index.

The phase 3 AMPLITUDE trial evaluated the safety and efficacy of adding niraparib to abiraterone acetate plus prednisone in patients with mHSPC.

Take a look through the top readouts in urologic oncology from ESMO 2025.

The mean baseline FACT-G total score for the niraparib group was 79.7 (standard deviation [SD], 14.9) and was 79.3 (SD, 15.2) for the placebo group.

In patients who were ctDNA positive, median DFS was 9.9 months (95% CI: 7.2-12.7) in the atezolizumab group vs 4.8 months (95% CI: 4.1-8.3) in the placebo group.

“Overall, the combination of saruparib plus an ARPI was well tolerated," Arun Azad, PhD, MBBS.

Regarding the primary end point, “4 patients showed a partial response, leading to a response rate of 17%," said Srikala S. Sridhar, MD, MSc, FRCPC.

Stephen J. Freedland, MD, reported that with combination enzalutamide/leuprolide, the risk of death was 40.3% lower vs leuprolide alone.

“This is the first trial to show an overall survival benefit in this population,” Christof Vulsteke, MD, PhD, noted.

Andrea Necchi, MD, reported a pCR rate of 38% (95% CI: 28-49) for cohort 1 vs 28% (95% Ci: 16-44) for cohort 2.

“POTOMAC met its primary end point of disease-free survival in the ITT [intent-to-treat] population," said Maria De Santis, MD.

"Observed efficacy of pembrolizumab plus lenvatinib were confirmatory of prior observations for this combination," said Cristina Suarez Rodriguez, MD, PhD.

“With 5 years of follow-up, median overall survival is longer with nivolumab vs placebo on interim analysis," said Matthew D. Galsky, MD.

"The addition of perioperative durvalumab to neoadjuvant chemotherapy significantly improved event-free survival and overall survival without adversely affecting patient-reported outcomes,” said Michiel van der Heijden, MD, PhD.

The grade 3-5 AE rate was 78.9% (95% CI, 70.8-85.6) in the 75 mg/m2 arm vs 61.2% (95% CI, 51.9-69.9) in the 50 mg/m2 arm (P =.0024).

Here’s a look back at notable news between July and September 2025.

We recap notable headlines from last month in the benign urology space.

A comprehensive guide to the key regulatory decisions and conferences slated for the last few months of the year.

Take a closer look at what urologists can expect from the LBAs that will headline ESMO 2025.

The biomarker panel demonstrated the ability to detect prostate cancer even in men with prostate-specific antigen levels in the normal range.

We recap notable headlines from last month in the benign urology space.

The ArteraAI test is now the first and only AI-powered tool to be authorized to prognosticate long-term outcomes in patients with localized prostate cancer.

“This designation is a powerful validation of our software's potential to transform how we treat cancer,” said Andre Esteva, CEO of Artera.

According to the news release, detailed OS data from EMBARK are set to be presented at an upcoming medical conference.

The investigational treatment is being evaluated in phase 1 clinical trials for solid tumors.