Francis Medical has reached a significant milestone in its VAPOR 2 clinical trial, completing enrollment of 235 patients ahead of schedule. The pivotal study aims to evaluate a novel water vapor ablation approach for treating intermediate-risk, localized prostate cancer.
"We are thrilled to announce the completion of enrollment in the VAPOR 2 study ahead of our expected timeline," said Dr. Samir Taneja of NYU Langone Health, the study's co-principal investigator. "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."
Trial Design and Patient Criteria
The prospective, multicenter, single-arm study spans 26 clinical sites across the United States. Eligible participants must be at least 50 years old with a life expectancy of 10 years or more. Additional inclusion criteria specify:
- Prostate size between 20 cc and 80 cc
- PSA levels of 15 ng/mL or lower
- Cancer stage ≤T2c
- Gleason grade 2 prostate cancer
Innovative Treatment Approach
The Vanquish Water Vapor Ablation device represents a novel approach to prostate cancer treatment, adapting technology similar to that used in BPH management. Dr. Arvin K. George of Johns Hopkins Medicine explains: "It's essentially the same treatment modality, using steam or water vapor and using convection rather than conduction to be able to treat prostate tissue. It has been redesigned to be able to perform the treatment directionally under image guidance or ultrasound MRI guidance."
The device employs phase shift energy stored in sterile water vapor to convectively transfer thermal energy to cancerous tissue, resulting in cell death. This targeted approach aims to provide precise treatment delivery while potentially minimizing impact on surrounding healthy tissue.
Study Endpoints and Future Timeline
The trial's primary effectiveness endpoint will assess freedom from:
- Systemic disease
- Systemic therapy
- Salvage therapy
- Gleason Grade Group 2 or higher at 36 months
Safety assessments focus on urinary continence at 12 months, with a key secondary endpoint evaluating preservation of erectile function at 36 months. Researchers will follow patients for up to 5 years to gather comprehensive long-term outcome data.
Regulatory Pathway
The FDA granted Breakthrough Device Designation to the Vanquish system in August 2023, recognizing its potential to address an unmet medical need. Francis Medical plans to use the VAPOR 2 trial results to support their FDA 510(k) clearance application, expected to be filed in July 2025. The study's primary completion is anticipated in April 2027.
