The Journal of urology · 2026
Water Vapor Therapy for the Management of Prostate Cancer: The VAPOR 2 Study Initial Results of Ablative Efficacy and Toxicity.
СтатьяМногоцентровое исследованиеНазвание и аннотация: Перевод в очереди
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George Arvin, Giesler Eric, Mazzarella Brian, Levin Richard, Frendl Daniel, Warlick Christopher, Given Robert, Kella Naveen, Frye Thomas, Mynderse Lance, Kasraeian Ali, Milbank Aaron, Nabbout Phillippe, Grunberger Ivan, Rastinehad Ardeshir, Schwartz Michael, Wysock James, Rousseau Michael, Pliskin Marc, Satkunasivam Raj, Rich David, Shore Neal D, Moreno Jose, Belkoff Laurence, Sidana Abhinav, Taneja Samir S
Аннотация
PURPOSE: The safety and effectiveness of water vapor for ablation of prostate tissue was assessed in men with intermediate-risk localized prostate cancer (PCa).
MATERIALS AND METHODS: A prospective, multicenter, single-arm study (VAPOR 2) was conducted in 235 men at 26 centers across the United States in men ≥ 50 years, with Gleason Grade Group 2 PCa confined to a single Prostate Imaging Reporting and Data System 3 or 4 abnormality on multiparametric MRI fusion biopsy, PSA level ≤ 15 ng/mL, and clinical stage ≤ T2c. Data presented are a predefined subset analysis of 110 men completing 12-month follow-up to assess only ablative efficacy and toxicity. Reported outcomes include biopsy 6 months post treatment PSA, prostate volume reduction, urinary/sexual function, quality-of-life questionnaires, and adverse events. The 3-year follow-up analysis will evaluate efficacy in PCa management, with 5 years of total follow-up.
RESULTS: The median age was 65 years, with a median baseline PSA of 5.6 ng/mL and prostate volume of 40.7 cc. On 6-month biopsy, targeted sampling of the treated region revealed benign tissue only in 75% and benign tissue or Gleason Grade Group 1 PCa in 91%. Regression analysis did not identify a significant baseline predictor of positive biopsy. PSA showed a median reduction of 58%, with a median 8 cc reduction in prostate volume. Urinary and sexual function showed an initial decline followed by gradual recovery through 12 months. Perioperative adverse events were generally mild and resolved without sequelae, with no reports of rectal injury.
CONCLUSIONS: The VAPOR 2 study demonstrated effective ablation of prostate tissue in men with localized, intermediate-risk PCa with low rates of procedural morbidity.
MATERIALS AND METHODS: A prospective, multicenter, single-arm study (VAPOR 2) was conducted in 235 men at 26 centers across the United States in men ≥ 50 years, with Gleason Grade Group 2 PCa confined to a single Prostate Imaging Reporting and Data System 3 or 4 abnormality on multiparametric MRI fusion biopsy, PSA level ≤ 15 ng/mL, and clinical stage ≤ T2c. Data presented are a predefined subset analysis of 110 men completing 12-month follow-up to assess only ablative efficacy and toxicity. Reported outcomes include biopsy 6 months post treatment PSA, prostate volume reduction, urinary/sexual function, quality-of-life questionnaires, and adverse events. The 3-year follow-up analysis will evaluate efficacy in PCa management, with 5 years of total follow-up.
RESULTS: The median age was 65 years, with a median baseline PSA of 5.6 ng/mL and prostate volume of 40.7 cc. On 6-month biopsy, targeted sampling of the treated region revealed benign tissue only in 75% and benign tissue or Gleason Grade Group 1 PCa in 91%. Regression analysis did not identify a significant baseline predictor of positive biopsy. PSA showed a median reduction of 58%, with a median 8 cc reduction in prostate volume. Urinary and sexual function showed an initial decline followed by gradual recovery through 12 months. Perioperative adverse events were generally mild and resolved without sequelae, with no reports of rectal injury.
CONCLUSIONS: The VAPOR 2 study demonstrated effective ablation of prostate tissue in men with localized, intermediate-risk PCa with low rates of procedural morbidity.