Study launches exploring water vapor ablation in localized prostate cancer

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 first patient has been treated in the VAPOR 2 trial, which is evaluating the Vanquish Water Vapor Ablation Device in patients with intermediate risk, localized prostate cancer, according to Francis Medical, the developer of the device.¹

The treatment was administered by Naveen Kella, MD, of The Urology Place in San Antonio, Texas.

"I am excited to be participating in the VAPOR 2 study and it is a great privilege to treat the first patient," Kella stated in a press release.¹ "Currently, prostate cancer patients find themselves in the difficult position of balancing the oncological risks of the disease with the life-altering side effects that can often accompany traditional treatments. Water vapor therapy shows great promise to provide patients with another option to proactively manage their cancer risk while preserving quality of life."

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.

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.²

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.²

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.

"Water vapor is an ideal tool for accomplishing this goal. It is simple, natural, and gentle, but powerful. The first VAPOR 2 study treatment is an important milestone bringing us one step closer to getting this groundbreaking technology into the hands of urologists and their patients." Michael Hoey, Francis Medical founder and chief technology officer, stated in the news release.¹

"We would like to thank our employees, investors, patients, and physician partners for bringing us to this stage. We are more confident than ever that this groundbreaking technology will ultimately become the first-line treatment of choice for men and their doctors," Michael Kujak, Francis Medical president and chief executive officer, added in the press release.¹

References

1. 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

2. 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