Category: MIS Image Guided/ Focal-cryo/RFA/HIFU: Prostate

MP23-15 - Development of Convective Water Vapor Energy For Treating Localized Prostate Cancer: First-In-Man Early Clinical Experiences.

Sat, Sep 22
2:00 PM - 4:00 PM

Introduction & Objective :

The Rezūm System™ currently being marketed for BPH and preclinical work with the Revīv System™ for localized prostate cancer have confirmed the unique ablation properties of convective water vapor (steam) ablation to treat the prostate. 

The objective was to assess in-vivo treatment of prostate cancer and the early clinical outcomes using the Revīv System™.

Methods :

Following IRB approval, 29 patients were treated at 2 centers using the Revīv™ System™. All had clinically localized disease as determined by biopsy, DRE, PSA, prostate MRI (non mp3) and bone scan. Treatment was performed using a urethral cooling catheter and a transperineal, ultrasound guided approach for needle placement and water vapor delivery. In selected patients, a combined transurethral and transperineal approach was used. In one patient, only transurethral treatment was used. Unilateral, partial unilateral, zonal or bilateral ablation was guided by the most recent pre-procedure biopsy result. Staged treatments were permitted. Follow-up monitoring included serial, gadolinium enhanced MRI’s performed at baseline, 1 week, 1, 3, and 6 and 12 months post-procedure. A surveillance biopsy at 6 months was performed. Oncologic outcome classification was determined by biopsy result. Standard AE reporting was used. 

Results :

29 patients were treated. 21 patients underwent a single treatment and 8 underwent a staged treatment. Mean TRUS baseline prostate volume was 42cc (range 21cc to 91cc).

Serial MRI’s at 1 week confirmed tissue ablation in all patients. Throughout the series, ablation was demonstrated to the prostatic apex, capsular boundaries and the anterior zones of the prostate.

18/29 have completed follow up biopsy, 9 are pending biopsy and 2 were not biopsied. 11/18 are biopsy negative, 5/18 were screening failures (contralateral disease and/or upgraded), and 2/18 are following AS (atypia only). Of the 13 non-screening failure patients, 11/13 (85%) are biopsy negative and 2/13 (15%) are following AS (atypia only).

To date, incontinence, bladder neck contractures or rectal fistula have not occurred. 1 patient required a partial TURP for tissue slough. 

Conclusions :

The zonal anatomy of the prostate is ideal for phase change convective ablation using water vapor. Serial MRI confirms effective ablation can be safely delivered anywhere in the prostate. Prostate size is not a barrier to treatment. Unilateral, focal, zonal or bilateral ablation can be performed. Staged treatments are feasible. Interim biopsy data is very promising and suggests that effective ablation with excellent oncologic control is achievable in the short term.

Christopher M. Dixon

Attending Urologist
Bon Secours Medical Group Suffern, NY
Bronxville, New York

Ramon Rodriguez Lay

Attending Urologist
Cirujano Urólogo Royal Center Panama City, Panama
Panama City, Herrera, Panama

Cesar Cabanas

Attending Urologist
Hospital Central del IPS, Asuncion, Paraguay
Asuncion, Asuncion, Paraguay

Ben Spilseth

Assistant Professor of Urology
Unuversity of Minnesota Medical Center
Minneapolis, Minnesota