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

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.

"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.

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

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

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

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, ...

The NRG-GU011 trial investigates relugolix plus SBRT versus SBRT alone in PET-oligometastatic prostate cancer. ORIOLE and STOMP studies indicate SBRT can delay recurrence without early ADT in some ...

CMS will separately reimburse diagnostic radiopharmaceuticals exceeding $630 per day, enhancing access to advanced nuclear medicine scans. The new policy, effective January 1, 2025, provides stable ...

Barrigel rectal spacer aims to protect the rectum during radiation therapy for prostate cancer, with FDA clearance for T1-T3b cases. The PPRT trial is the first to include patients with recurrent ...