Published VAPOR 2 data evaluate water vapor ablation for localized prostate cancer

Results from the VAPOR 2 study (NCT05683691) have been published in the Journal of Urology, showing that water vapor therapy can effectively ablate prostate tissue in men with localized, MRI visible grade group 2 (GG2) prostate cancer.¹

"This publication adds to the growing body of evidence supporting thermal water vapor ablation as a promising focal therapy ablative modality," said co-principal investigator author Samir S. Taneja, MD, of Northwell Health, in a news release on the findings.² "The ability to target and ablate prostate tissue while minimizing impact on surrounding structures may provide an important treatment option for appropriately selected patients."

About the VAPOR 2 trial

VAPOR 2 is a prospective, multicenter, single-arm study enrolling men with intermediate-risk localized prostate cancer. Participants in the study needed to be 50 years and older with a single PI-RADS 3 or 4 lesion on multiparametric MRI, biopsy-confirmed GG2 disease, a prostate-specific antigen (PSA) of 15 ng/mL or less, and clinical stage T2c or lower. All patients underwent transurethral focal ablation using the Vanquish System in an outpatient ambulatory setting.

The data represent a predefined interim analysis of the first 110 participants who completed 12 months of follow-up. Patients were enrolled in the study across 26 clinical trial sites in the US. The median age was 65 years, and the median baseline PSA was 5.6 ng/mL.

At 6-month MRI targeted biopsy of the treated zone, 75% of men had entirely benign tissue and 91% had no residual GG2 disease. Further, 83% of men demonstrated visual clearance of the regions of interest at 6-month follow-up MRI. The median PSA decreased from a baseline of 5.6 ng/mL to 2.3 ng/mL at 12 months (58% reduction; P < .001). The median prostate volume decreased by roughly 8 cc, from a baseline of 40.7 cc (−21%; P < .001).

Urinary and sexual function scores dipped in the immediate post-procedure period before gradually recovering through 12 months. New or worsening erectile dysfunction (ED) was reported in 28 men, of which 18 had ongoing ED at 12 months. Seven men experienced transient urinary incontinence resolving without surgical intervention, and 8 men reported ongoing urinary incontinence at 12 months. 

Investigators reported no device-related serious adverse events and no rectal injuries, with perioperative complications described as generally mild and self-limited.

Conclusions and next steps

"The publication of the VAPOR 2 study in the Journal of Urology represents a significant milestone for Francis Medical and for the evolving field of focal therapy," said Mike Kujak, president and CEO of Francis Medical, in the news release.² "The initial results support the potential of water vapor ablation as a safe and effective minimally invasive therapy capable of achieving meaningful prostate tissue ablation while preserving quality of life in men with localized prostate cancer."

Francis Medical stated that continued VAPOR 2 follow-up is intended to support a premarket approval submission for an expanded indication of the Vanquish device for the management of clinically localized prostate cancer.

The device is currently cleared in the US for the thermal ablation of targeted prostate tissue via a transurethral approach. The FDA has not evaluated the device for the treatment of any disease, including prostate cancer, nor for any long-term prostate cancer treatment outcomes.

REFERENCES

1. George A, Giesler E, Mazzarella B, et al. Water vapor therapy for the management of prostate cancer: The VAPOR 2 study initial results of ablative efficacy and toxicity. J Urol. 2026;0(0). doi:10.1097/JU.0000000000005156

2. Francis Medical announces publication of VAPOR 2 pivotal trial results in The Journal of Urology. News release. Francis Medical, Inc. June 30, 2026. Accessed July 2, 2026. https://www.francismedical.com/francis-medical-announces-publication-of-vapor-2-pivotal-trial-results-in-the-journal-of-urology/