Patient Enrollment Completed in VAPOR 2 Trial for Vanquish Prostate Cancer Therapy

Francis Medical, a medical device company developing water vapor ablation therapy for the treatment of prostate, kidney, and bladder cancer, announced the completion of patient enrollment and initial treatments in its VAPOR 2 pivotal trial for Vanquish.

The Vanquish device’s thermal water vapor energy technology is a breakthrough therapy designed to use phase shift energy stored in sterile water vapor to convectively transfer thermal energy to cancerous tissue, causing cell death. Through this process, damage to surrounding structures can be minimized or eliminated by respecting the prostate’s natural boundaries.

The VAPOR 2 trial is a prospective, multicenter, single-arm study treating 235 patients with intermediate-risk, localized prostate cancer at 26 U.S. clinical sites. Data gathered from the VAPOR 2 study will support 510(k) clearance of the Vanquish device, which the company expects to file for in July 2025.

Patients will continue to be followed for a period of five years to gather longer-term cancer outcomes. Dr. Samir Taneja from NYU Langone and Dr. Arvin George from Johns Hopkins are co-principal investigators on the study. “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,” said Dr. Taneja.

Michael Kujak, CEO of Francis Medical, credited the achievement to collaboration between researchers, patients, and the company’s team. “We are incredibly proud of the entire team for achieving this key milestone; thanks to all the VAPOR 2 participants for partnering with us to help move closer to a kinder, gentler treatment for prostate cancer,” said Kujak.

What’s Next?

Pending FDA clearance, Vanquish may offer a minimally invasive alternative for the 299,000 U.S. men projected to be diagnosed with prostate cancer in 2024. While five-year data will be critical to confirm long-term efficacy, researchers are optimistic.

Prostate cancer is the second most common cancer affecting men in the United States, with the American Cancer Society estimating that 1 in 8 men will be diagnosed during their lifetime. Existing treatments can lead to challenging complications such as urinary incontinence and erectile dysfunction.