Abstract
Purpose: 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 (PCa). Materials and Methods: Men ‡45 years of age with biopsy-confirmed unilateral Gleason grade group 2 (GGG2) adenocarcinoma of the prostate, prostate volume of 20–80 cc, and prostate-specific antigen (PSA) £15 ng/mL were enrolled. Cystoscopy and transrectal ultrasound (TRUS) guidance were used to deliver *103C water vapor to prostate zones for unilateral hemigland ablation, including destruction of cancers detected by multiparametric MRI (mpMRI) and confirmed by biopsy. The primary outcomes were device-related serious adverse events (SAEs). At 7 days and 6 months postprocedure, the ablation extent was assessed by mpMRI; MRI/TRUS fusion biopsies were completed at 6 months. Quality of life (QOL) was assessed with validated questionnaires. Results: All subjects underwent a single hemigland 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%) visible lesions. 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 (67%) subjects were biopsy negative. Of the 5 biopsy-negative subjects, 2 had one core each of 3 + 4 disease and 3 had one core each of 3 + 3 disease with £5% involvement. Median prostate volume was reduced by 40.7% and PSA by 58%. Extensive QOL assessments showed, on average, no appreciable negative effects of treatment. Conclusions: Initial evidence suggests that TUVA is safe in men with intermediate-risk PCa. Preliminary results demonstrate the absence of ‡GGG2 disease on the treated side in 87% of men and a favorable QOL profile.
Original language | English (US) |
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Pages (from-to) | 225-232 |
Number of pages | 8 |
Journal | Journal of endourology |
Volume | 37 |
Issue number | 2 |
DOIs | |
State | Published - Feb 1 2023 |
Bibliographical note
Funding Information:Support for the study was provided by Francis Medical, Inc., Maple Grove, MN.
Publisher Copyright:
ª Mary Ann Liebert, Inc.
Keywords
- focal ablation
- minimally invasive surgical therapy
- mpMRI
- prostate
- prostate cancer
- transurethral vapor ablation (TUVA)
PubMed: MeSH publication types
- Multicenter Study
- Journal Article
- Research Support, Non-U.S. Gov't