The NDA submission is supported by data from a single-arm, phase 3 trial of leuprolide mesylate administered as 2 injections, 3 months apart.

"The scale of that linkage and the manner with which we were able to do it is really exciting and opens the door for a lot of future discovery," says Michael S. Leapman, MD, MHS.

“Our study is distinguished by long follow-up, out to 12 years, looking at a broad spectrum of key complications," says Joseph M. Unger, PhD.

The phase 3 ENVISION trial met its primary end point by demonstrating a 79.6% complete response rate at 3 months following the first instillation of the therapy.

Overall, 15/16 patients had a true positive scan based on confirmatory imaging and/or biopsy, equating to a PPV of 93.75%.

Lifestyle modifications, including yoga, hypnosis, and nutraceuticals, are increasingly used in BPH management, reflecting a trend towards integrating alternative medicine with traditional treatments.

68Gallium PSMA-11 PET is preferred for confirming lutetium therapy eligibility due to its high specificity in detecting PSMA expression. Alternatives include 18F-DCFPyL PET, which also targets PSMA, ...

"Over a third of Americans actually use some kind of what we term complementary or alternative medicine approach," says Raevti Bole, MD.

Olaparib significantly improved radiographic progression-free survival and overall survival in metastatic prostate cancer with HRR gene alterations. Safety profiles of PARP inhibitors were consistent ...

The TALAPRO-2 study authors noted that the use of androgen receptor (AR)–targeted therapy in clinical practice has increased considerably in recent years. How might prior use of AR-targeted therapy ...

The study is a large, multi-center, independently funded cohort series on Peyronie's disease treatment satisfaction. Patients who underpredict their penile curvature report higher satisfaction ...