The development of the current Vanquish™ System for the focal treatment of prostate cancer evolved from the Rezum system and several transperineal devices. In addition, a considerable amount of investigation was done using human extirpated prostates as well as work in human cadavers to develop procedure techniques. The Peri I (Treat and Resect) study investigated the rst-generation Reviv transperineal device invivo in men already scheduled to undergo radi­cal prostatectomy. The primary objective was to understand the safety of transperineal vapor delivery and the dosage required to ablate tissue effectively in different zones of the prostate. Sixteen men were treated with doses ranging from 21 to 33 calories/s, and upon tissue staining with TTC of the prostatectomy specimen, ade­quate ablation was identied in the peripheral, transition, and central zones with no associated serious adverse events in any of the men (data courtesy of Francis Medical) (Fig.31.11).

The Reviv rst-in-man study evaluated the dosimetry and safety of the transperineal approach in the beginning and transitioned to the transurethral approach by the end. Twenty-nine men were treated and followed for up to 2 years. The transurethral device was used for initial treatment in one subject and for repeat treatment in 10 subjects. The results from these 11 men established the safety of water vapor ablation and guided the development of the Vanquish™ device (data courtesy of Francis Medical).

There were seven reported adverse events in six of the patients, though per the site investiga­tor, none were attributed to the study device or procedure. All events were mild in severity and occurred either during the radical prostatectomy or afterward (data courtesy of Francis Medical).

Key inclusion criteria were unilateral GGG2, clinical stage ≤T2b N0 M0, prostate volume 20–80 cc, and PSA of ≤15 ng/ml. Initial hemiab­lation was performed in all subjects. For subjects with newly diagnosed or residual GGG2 disease at the 6-month posttreatment biopsy, an addi-

The 6-month biopsy demonstrated no Gleason pattern ≥4 cancer on the treated side in 13 of 15 (87%) subjects, and was negative for any cancer on the treated side in 10 of 15 (67%) subjects. The two subjects who had residual Gleason pat­tern 4 were positive for Gleason 7 (3 + 4) disease,

After the promising results of the VAPOR 1 study, the VAPOR 2 study was developed and opened to enrollment in May 2023. This is a larger prospec­tive, multicenter, single-arm design to determine the full safety and effectiveness of the Vanquish device in subjects with GGG2 localized, intermediate-risk prostate cancer. The study will activate up to 35 sites in the United States, with a planned sample size of 235 subjects. After enrollment, subjects will be screened for eligibility by central MRI review, base­line testing, and historical data collection to ensure the subjects meet all inclusion and exclusion criteria.

Key inclusion criteria are ≥50 years of age, pros­tate size of 20–80 cc by MRI, PSA ≤15 ng/mL, tumor stage ≤T2c, MRI with one single region of

If, at any time during follow-up, subjects pres­ent with biopsy-conrmed favorable GGG2 dis­ease, they may be eligible based on criteria to receive additional treatment (of newly diagnosed cancer in an untreated region) or one repeat treat­ment (of residual cancer in the previously treated region) with the Vanquish system. Subjects who elect to undergo another type of prostate cancer treatment will be followed through 60 months on an annual basis.

For prostate tissue ablation analysis, the pri­mary endpoint for effectiveness will be a negative biopsy in the regions of the prostate targeted for treatment, evaluated at 6 months after ablation. For prostate cancer analysis, the primary end­point for effectiveness will be freedom from fail­ure, which is dened as freedom from systemic