Prostate Cancer

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%.

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

A comprehensive guide to the key regulatory decisions and conferences slated for Q3 of 2025.

The unfortunate news of President Biden’s diagnosis has put a spotlight on prostate cancer, offering an opportunity to educate on the risks of the disease and the benefits of screening.

The test utilizes chromosomal instability signatures to predict resistance to taxane-based chemotherapy in metastatic prostate cancer.

The results demonstrated a favorable ratio between radiation doses absorbed in the tumor vs the doses delivered to key healthy organs.

The approach was associated with a 30% decrease in PSMA uptake by the salivary glands without compromising the treatment’s efficacy.

The phase 1 study is set to begin later this year.

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

"Overall, these findings add to the growing body of evidence that [shows that] apalutamide may offer a survival advantage in real-world setting in patients with metastatic castration-sensitive prostate cancer," says Mehmet A. Bilen, MD.

The IDeate-Prostate01 trial plans to enroll approximately 1440 patients whose tumors progressed following prior treatment with an ARPI.

ArteraAI is a multimodal artificial intelligence biomarker test that can predict therapy benefit and prognosticate long-term outcomes in prostate cancer.

“Our findings support that that we do not drop the label of cancer from grade group 1 nomenclature," says Jim C. Hu, MD, MPH.

A significant challenge lies in differentiating prostate cancer symptoms from common age-related issues.

Pfizer has chosen to no longer pursue an expanded indication for talazoparib plus enzalutamide in non-HRR gene mutated mCRPC in the US as a result of this decision.

Murilo De Almeida Luz, MD, discusses data on PSA and ALP changes in patients receiving enzalutamide plus radium-223 vs enzalutamide alone.

A primary concern was establishing trust in the connectivity to ensure no loss in visualization or connection.

One key approach is to increase the representation of women on editorial boards of journals and as reviewers.