Enrollment goal met in trial of Vanquish device for localized prostate cancer

The target enrollment has been met in the pivotal VAPOR 2 trial (NCT05683691), assessing the safety and efficacy of the Vanquish Water Vapor Ablation device in patients with intermediate-risk, localized prostate cancer, Francis Medical announced in a news release.¹

Patients will be followed for up to 5 years.

In total, the trial enrolled 235 patients across 26 clinical trial sites in the US. All patients enrolled in the study have completed their initial treatment.

"We are thrilled to announce the completion of enrollment in the VAPOR 2 study ahead of our expected timeline," said co-principal investigator Samir Taneja, MD, of NYU Langone Health, in the news release.¹ "For a study of this scale to finish enrollment early is a remarkable achievement and speaks to the dedication of our participating investigators and the level of excitement surrounding this promising technology."

Overall, the prospective, multicenter, single-arm VAPOR 2 study is assessing the safety and efficacy of Vanquish in adult patients with Gleason grade 2 prostate cancer.² Those enrolled in the study will receive transurethral delivery of water vapor ablation.

To be eligible for enrollment, patients needed to be at least 50 years of age and have a life expectancy of at least 10 years. Participants must also have a prostate size between 20 cc and 80 cc, a prostate-specific antigen level of 15 ng/mL or lower, and a cancer stage less than or equal to T2c, among other requirements.

The primary effectiveness end point is freedom from systemic disease, systemic therapy, salvage therapy, and a Gleason Grade Group of 2 or higher at 36 months. The primary safety end point is the proportion of patients who are free from new or worsening urinary incontinence at 12 months. A key secondary end point of the trial is the proportion of patients who are free from impotence at 36 months.

Patients in the study will continue to be followed for up to 5 years to assess long-term outcomes. Primary completion of the trial is expected in April 2027.

Details on the Vanquish device

According to Francis Medical, the Vanquish device is “designed to use phase shift energy stored in sterile water vapor to convectively transfer thermal energy to cancerous tissue, causing cell death.” The FDA granted a breakthrough therapy designation to the device in August 2023.³

In a past interview with Urology Times®, co-investigator Arvin K. George, MD, of Johns Hopkins Medicine, Baltimore, Maryland, explained how this technology has been replicated from what is currently being done in the management of benign prostatic hyperplasia (BPH) with Rezum treatment.

“It's essentially the same treatment modality, using steam or water vapor and using convection rather than conduction to be able to treat prostate cancer or prostate tissue,” George explained. “It has been redesigned to be able to perform the treatment directionally, meaning that we can get the water vapor or steam exactly where we want it within the prostate under image guidance or ultrasound MRI guidance.”

Francis Medical also noted that results from the VAPOR 2 trial will support a submission to the FDA for 510(k) clearance of the device. The company expects to file the application with the agency in July 2025.

References

1. Francis Medical announces completion of enrollment in the VAPOR 2 pivotal study for Vanquish prostate cancer treatment. News release. Francis Medical, Inc. February 25, 2025. Accessed February 26, 2025. https://www.francismedical.com/completion-of-vapor-2-enrollment-for-vanquish-prostate-cancer-treatment/

2. Water vapor ablation for localized intermediate risk prostate cancer (VAPOR 2). ClinicalTrials.gov. Last updated January 8, 2025. Accessed February 26, 2025. https://clinicaltrials.gov/study/NCT05683691

3. Francis Medical receives U.S. FDA Breakthrough Device Designation for Vanquish minimally invasive prostate cancer therapy. Francis Medical, Inc. August 1, 2023. Accessed February 26, 2025. https://www.francismedical.com/press-release-francis-medical-receives-fda-breakthrough-device-designation-for-vanquish/