Hannah Clarke

We recap notable headlines from last month in the urologic oncology space.

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

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

The device features a 12 French working channel, the largest of any flexible single-use cystoscope.

Daniel Spratt, MD, presented data validating the PAM50 gene expression signature as the first predictive biomarker to guide hormone therapy in prostate cancer.

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

According to the authors, CAN-2409 may represent the first new treatment option for men with localized prostate cancer in over 2 decades.

The PREDICT-RT trial is evaluating intensified or de-intensified concurrent hormone therapy and radiation regimens in high-risk prostate cancer.

Take a look through the key trials investigating BCG/ICI combinations in BCG-naïve NMIBC.

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

The study is designed to evaluate the safety, efficacy, tolerability, and pharmacokinetics of FG-3246 in patients with mCRPC.

This clearance adds onto a previous indication for the BioTraceIO platform in liver tumor ablation.

The approval is supported by data from the phase 3 MK-3475A-D77 trial.

The Altaviva device is a minimally invasive implantable tibial neuromodulation therapy for patients with urge urinary incontinence.

According to the authors, these findings suggest that FloStent could serve as an effective interim solution for men who are awaiting TURP.

The phase 2 trial has shown encouraging safety and efficacy results for carotuximab and apalutamide in patients with mCRPC.

Both the Dornier Hoover Flexible and Navigable Suction Ureteral Access Sheath and the Dornier Axis II Slim single-use ureteroscope are FDA-cleared.

The trial enrolled over 700 high-risk participants across 20 clinical trial sites in Taiwan.

Recent data suggests a lack of knowledge among primary care providers on the value of prostate specific antigen testing, particularly for patients in high-risk groups.

According to the authors, these findings suggest that biparametric MRI could become the new standard of care for prostate cancer diagnosis.

The Focalist device obtained FDA clearance in the US in July 2025.

Tom Jayram, MD, discusses rationale for selective FGFR3 inhibition in bladder cancer as well as what’s needed to bring this treatment modality into routine clinical practice.

Two-year outcomes from the ASPIRE trial continued to show that the SURE procedure led to significantly reduced health care consumption events compared with ureteroscopy.

The NDA is supported by data from a phase 3 trial, which demonstrated a 75% complete response rate at 3 months.

The registrational trial is aiming to expand the indications for Illuccix and Gozellix to include use in prostate cancer diagnosis.

Data showed a marked or moderate improvement in IC/BPS symptoms in 41% of patients who received sunobinop vs 9% of patients who received placebo.

Data from the SunRISe-1 trial showed a complete response rate of 82%, with 51% of patients remaining in complete response for at least 1 year.

Patients will be enrolled in the study through clinical trial sites in the US, with additional international sites to follow.

At the time of data report, the median progression-free survival and duration of response had not been reached in either cohort.