Prostate Cancer

The phase 1 STRIKE-001 trial will evaluate KTX-2001 as both a monotherapy and in combination with darolutamide.

Data from the phase 2 EXTEND trial showed that the addition of metastasis-directed therapy to ADT improved measures of systemic disease control.

Take a look through key stories from last month, including regulatory news, trial updates, and other practice-changing advancements.

INKmune was well-tolerated across all 3 dose levels assessed.

Data showed that 1 in 6 men with GG1 prostate cancer ultimately had higher-risk disease when other clinical features were taken into account.

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

ATNM-400 demonstrated improved efficacy compared with 177Lu-PSMA-617 in treatment-resistant models as well as enhanced efficacy in combination with enzalutamide.

Enzalutamide plus ADT was associated with significant improvements in rPFS and time to castration resistance compared with darolutamide plus ADT.

The 500 mg regimen of abiraterone acetate demonstrated comparable anti-tumor activity and a favorable safety profile compared with the standard 1000 mg dose.

The WATER IV PCa trial is comparing first-line Aquablation therapy with radical prostatectomy for the treatment of patients with localized prostate cancer.

The new advanced annotation workflow on the UroNav System is designed to work in tandem with DynaCAD Urology to support focal therapy planning.

Panelists discuss how the treatment paradigm for androgen deprivation therapy is evolving from traditional injectable GnRH agonists to include oral GnRH antagonists like relugolix, which offer more rapid onset, faster recovery, and avoidance of testosterone flare.

The PRESERVE trial met its primary end point by demonstrating a negative in-field biopsy rate of 71% at 12 months.

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

In both cohorts, the combination of talazoparib plus enzalutamide led to a significant improvement in overall survival vs enzalutamide alone.

Take a look back through some of the top stories from the first half of the year.

Data showed that African American men faced significant delays in treatment initiation.

The level II code A9616 will be effective starting on October 1, 2025.

The company said it plans to report interim efficacy data from the trial in September 2025.

“Our data support adherence to guideline recommendations for treatment of prostate cancer,” says Pietro Scilipoti, MD.

“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.

For the trial, a biomarker will be utilized to aid in patient selection for the treatment.

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.

Catch up on exclusive videos you may have missed from the first half of the year.

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

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

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