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SBRT and prostatectomy show comparable cancer control in PACE-A; tibial nerve implant codes announced; FDA fast-tracks pre-biopsy PSMA-PET
THE SHORT READ
Eight-year results of the PACE-A trial, presented Sept. 28 at the American Society for Radiation Oncology meeting, showed comparable cancer control after stereotactic body radiotherapy (SBRT) and radical prostatectomy, with less incontinence after SBRT. Medtronic and BlueWind Medical announced that the American Medical Association (AMA) approved Category I Current Procedural Terminology (CPT) codes for implantable tibial neuromodulation, effective January 2028. The Food and Drug Administration (FDA) granted fast track designation to a phase 3 program testing prostate-specific membrane antigen (PSMA) PET before biopsy.
THE DETAILS
- Research Sept 28, 2026The phase 3 trial randomized 123 men with localized prostate cancer (94% low or intermediate risk) at eight U.K. centers to SBRT or radical prostatectomy. After a median follow-up of eight years, 91% of SBRT and 84% of surgical patients remained free from biochemical or clinical failure, a difference that was not statistically significant. At five years, 8% of SBRT patients reported using at least one urinary pad versus 48% after surgery; median erectile-function scores were 19 versus 5 on a 25-point scale. Principal investigator Dr. Nicholas van As said too few cancer events occurred to conclude SBRT was superior.Sources: ASTRO release (News-Medical), Urology Times
- Payment Oct 1, 2026The codes, issued by the American Medical Association's CPT Editorial Panel, replace the Category III tracking codes now used and separate subfascial implantation from subcutaneous implantation, according to Urology Times. Medtronic, maker of the Altaviva device, announced the codes Oct. 1, and BlueWind Medical, maker of the Revi System, also announced them. BlueWind said separate codes will let payers tell the two approaches apart in claims data. Medtronic said urge urinary incontinence affects 16 million adults in the U.S.Sources: Medtronic (PR Newswire), Urology Times
- FDA Sept 30, 2026The phase 3 BiPASS study is evaluating gallium-68 PSMA-PET combined with prostate MRI before biopsy, using Telix's Illuccix and Gozellix kits. Telix said Sept. 30 that it recently completed enrollment and is planning a new drug application for pre-biopsy use. Fast track designation can bring more frequent interactions with the Food and Drug Administration and eligibility for accelerated approval and priority review, according to Urology Times.Sources: Telix Pharmaceuticals, Urology Times