Transurethral Vapor Ablation in Patients with Intermediate Risk Localized Prostate Cancer.

We report results of a prospective, multicenter, single-arm study of transurethral vapor ablation (TUVA) of prostate tissue in patients with unilateral, intermediate risk localized prostate cancer.

Men ≥45 years of age with biopsy confirmed unilateral Gleason Grade Group 2 (GGG2) adenocarcinoma of the prostate, prostate volume 20-80 cc, and PSA ≤15 ng/mL were enrolled. Cystoscopy and transrectal ultrasound (TRUS) guidance were used to deliver ~103°C water vapor to prostate zones for unilateral hemi-gland ablation including destruction of cancers suspected by mpMRI and confirmed by biopsy. The primary outcome was device-related serious adverse events (SAEs). At 7 days and 6 months post-procedure, ablation extent was assessed by mpMRI; MRI/TRUS fusion biopsies were completed at 6 months. Quality of life (QOL) was assessed with validated questionnaires.

At baseline 8/15 subjects had positive biopsy cores of GGG1 cancer on the targeted treatment side. All subjects successfully underwent a single hemi-gland TUVA procedure. No SAEs occurred. Grade 2 procedure-related AEs included transient urinary retention (n=4) and erectile (n=1) or ejaculatory dysfunction (n=1). At 7 days, mpMRI revealed complete ablation of 14/17 (82%) lesions visible. At 6 months, biopsies showed no Gleason pattern ≥ 4 or ≥ GGG2 cancer on the treated side of prostates in 13/15 (87%) subjects. Ten of 15 (66.7%) subjects had no evidence of cancer; 2/5 biopsy positive subjects had one core each of 3+4 disease, and 3/5 had one core each of 3+3 disease, all ≤5% involvement. Median prostate size was reduced 40.7% and PSA by 58%. Extensive QOL assessments showed on average no appreciable negative effects of treatment.

Initial evidence suggests TUVA is safe in men with intermediate-risk prostate cancer. Preliminary results demonstrate the absence of ≥ GGG2 disease on the treated side in 87% of men and a favorable QOL profile.

Journal of endourology. 2022 Oct 31 [Epub ahead of print]

Christopher Michael Dixon, Richard M Levin, Chistopher H Cantrill, Mikhail Regelman, Benjamin Spilseth, Ronald F Tutrone, Michael A White, Aaron J Milbank, Chris Warlick

WMC Health Good Samaritan Hospital , Urology, Suffern, New York, United States; ., Chesapeake Urology, Baltimore and Annapolis, Urology, Baltimore, Maryland, United States; ., Urology of San Antonio Research, Urology, San Antonio , Texas, United States; ., Minnesota Urology, 217633, Urology, Woodbury, Minnesota, United States; ., University of Minnesota, Urology, Minneapolis, Minnesota, United States; ., Chesapeake Urology, Baltimore and Annapolis, Urology, Baltimore, Maryland, United States; ., Urology of San Antonio Research, Urology, San Antonio, Texas, United States; ., Minnesota Urology, 217633, Urology, Woodbury, Minnesota, United States; ., University of Minnesota, Urology, Minneapolis, Minnesota, United States; .

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