All News

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.

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.

"I'm excited to see how these models are going to continue to be developed and applied in clinical practice, because precision medicine is here, and I’m looking forward to it," says Madhur Nayan, MD, PhD.

However, this regimen was associated with substantial toxicity, so careful patient selection is paramount, according to the authors.

In preclinical studies, ACE-232 demonstrated superior potency, efficacy, and pharmacokinetic properties compared with other CYP11A1 inhibitors.

"As clinicians, researchers, and advocates, this moment invites us to reflect on how far we’ve come—and how much further we must go," writes Michael S. Cookson, MD, MMHC, FACS.

In 2015, 1245 patients had prostate cancer and had also initiated a GLP-1 or GIP/GLP-1 receptor agonist compared with 69,808 patients in 2024.

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.

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.

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

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

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.

Overall, 59% of patients achieved at least a 50% decline in PSA level.

The company plans to submit a Biologics License Application to the FDA at the end of 2026.

However, the data did not show any benefit of a docetaxel doublet vs an ARPI doublet.

The application is seeking an expanded indication of talazoparib plus enzalutamide for mCRPC.

Results from the phase 3 AMPLIFY trial are intended to support an application to the FDA for potential approval of 64Cu-SAR-bisPSMA.

The phase 3 study design will now be submitted for final review by the agency.

The study found differences in genomic alteration frequencies between non-Hispanic Black and non-Hispanic White veterans with metastatic prostate cancer, but showed similar survival outcomes.

Data from the SCIMITAR trial showed that SBRT appeared safe and demonstrated comparable PROs compared with CFRT.