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

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

Research output: Contribution to journalArticlepeer-review

4 Scopus citations

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 languageEnglish (US)
Pages (from-to)225-232
Number of pages8
JournalJournal of endourology
Volume37
Issue number2
DOIs
StatePublished - 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

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