FDA grants Breakthrough Device Designation to Vanquish water vapor ablation treatment for prostate cancer

The FDA has granted a Breakthrough Device Designation to the Vanquish minimally invasive water vapor ablation device for patients with prostate cancer, according to Francis Medical, Inc., the developer of the treatment.¹

The prospective, single-arm VAPOR 2 study will treat 235 patients. All patients will receive transurethral delivery of water vapor ablation. The study is being conducted at up to 30 clinical sites in the United States.

The designation will expedite the development and regulatory review of Vanquish. Benefits of the designation include priority review from the FDA for clinical trial protocols and commercialization decisions, and potentially facilitating Medicare reimbursement if the FDA approves the device.

“The goal of Francis Medical is to become the first line therapy of choice for patients with prostate cancer,” Michael Kujak, Francis Medical president and chief executive officer, stated in a press release.¹ “We are excited that the FDA has recognized the potential of our technology to be a breakthrough for patients who today face the difficult choice between addressing their cancer and avoiding the debilitating morbidities often associated with current standards of care.”

The Vanquish device is currently being assessed in the VAPOR 2 trial, which is evaluating the treatment in patients with intermediate risk, localized prostate cancer.² The first patient has been treated in the study by Naveen Kella, MD, of The Urology Place in San Antonio, Texas.

The prospective, single-arm VAPOR 2 study will treat 235 patients. All patients will receive transurethral delivery of water vapor ablation. The study is being conducted at up to 30 clinical sites in the United States.²

To enroll on the study, patients must be at least 50 years old and have a life expectancy of at least 10 years. At baseline, patients must have a prostate size of 20 cc to 80 cc, as determined by MRI Central Imaging, a PSA level of ≤15 ng/ml, and a cancer stage ≤T2c.³

Patients are prohibited from enrollment if they have >GGG3 cores anywhere in the prostate; extracapsular extension of cancer shown on MRI; all PI-RADS 5 lesions; or received any prior surgery, minimally invasive therapy, or intervention for prostate cancer. Patients also cannot be taking medications, such as LHRH agonists or 5ARIs, that have a hormonal impact on the prostate or PSA level.³

The primary efficacy end point of the study is freedom from all of the following: systemic disease, systemic therapy, salvage therapy, and GGG≥2. The study includes a primary safety end point related to urinary incontinence and a key secondary end point related to impotence.

The estimated primary completion date for the study is April 2027.

References

1. Francis Medical Receives U.S. FDA Breakthrough Device Designation for Vanquish Minimally Invasive Prostate Cancer Therapy. Published online August 1, 2023. Accessed August 2, 2023. https://www.francismedical.com/press-release-francis-medical-receives-fda-breakthrough-device-designation-for-vanquish

2. Francis Medical Announces First Patient Treated in VAPOR 2 Pivotal Study for Water Vapor Ablation of Prostate Cancer. Published online July 19, 2023. Accessed July 20, 2023. https://www.prnewswire.com/news-releases/francis-medical-announces-first-patient-treated-in-vapor-2-pivotal-study-for-water-vapor-ablation-of-prostate-cancer-301880508.html

3. NIH US National Library of Medicine ClinicalTrials.gov. Water Vapor Ablation for Localized Intermediate Risk Prostate Cancer (VAPOR 2). First posted January 13, 2023. Last updated July 11, 2023. https://classic.clinicaltrials.gov/ct2/show/NCT05683691