Steam to Kill Prostate Cancer

 The FDA has approved the Vanquish Water Vapor Ablation System, which uses steam to destroy prostate tumors. However, the efficacy of the device in eliminating cancer has yet to be established, according to the manufacturer, Francis Medical, Inc. 

The FDA granted the device 510(k) clearance based on early data from the VAPOR 2 study showing the therapy eradicated localized prostate cancer in an initial cohort of patients. The approval enables the company to launch the technology while it collects two more years of data to support a premarket approval application for management of prostate cancer. 

Men treated in VAPOR 2 will be followed to see if the treatment prevents the development of lethal cancers, Gleason Grade Group 7 or higher, anywhere within the prostate, and to better define the extent of adverse events (including incontinence and erectile dysfunction) associated with therapy.

The prospective, single-arm study enrolled 235 patients with intermediate-risk prostate cancer at 26 clinical sites in the United States. The FDA approval was based on 12-month follow-up data on the first 110 patients. The 6-month biopsy data on these patients showed that a single treatment with the Vanquish system eradicated clinically significant (defined as at least Gleason Grade Group 2) prostate cancers in 91% of these patients. The treatment eliminated 70% of cancerous tissue in the targeted area, Francis Medical said. 

The researchers reported no device-related serious adverse events in the study. However, 16.4% of men had ongoing erectile dysfunction events and 2.7% had Grade 2 urinary leakage. In response to a questionnaire, 94% of men in the study agreed with the statement that their decision to receive the treatment was a wise one, and 93% said they were satisfied with the treatment. 

“As urologists, our goal is to be able to manage prostate cancer by eliminating any prostate cancers that have lethal potential while being able to maintain preservation of the prostate, and also, as a result, preservation of quality of life with respect to urinary incontinence and erectile dysfunction,” said Arvin George, MD, director of prostate cancer programs at the Brady Urological Institute of the Johns Hopkins University School of Medicine in Baltimore, and co-principle investigator of the VAPOR 2 study. 

The results of the study have not yet been published. A summary of the findings was presented at the FOCAL+ conference in October. 

Limited Data

Other experts in the field say the data look promising but more is needed to show that the device is effective in eliminating prostate cancer.

“That roughly 90% freedom from clinically significant disease at the 6-month endpoint I think is encouraging. I think it’s in line with what we see with competing technologies,” said George Schade, MD, an associate professor at the University of Washington School of Medicine in Seattle, and a physician at Fred Hutchinson Cancer Center. “And obviously 6 months is a really short endpoint, so it’ll be important to see how that data evolves.” 

Adam Weiner, MD, an assistant professor of urology at Cedars-Sinai Center in Los Angeles and adjunct assistant professor of urology at the University of California, Los Angeles, said the elimination of lesions detected with MRI is not a proven oncologic outcome. “It’s a surrogate outcome that they’ve done for this early study that is based on imaging. It does show us that the technology works to remove prostate tissue. It doesn’t tell us really does it treat prostate cancer well,” he said.

Weiner said more details are needed about the patients whose tumors disappeared on imaging, where the prostate cancer was located, and what the biopsies showed. 

Potential Advantages and Disadvantages

The Vanquish system consists of a transurethral delivery device that is inserted through the urethra into the prostate. A catheter needle at the end extends into the treatment area and delivers water vapor directly into the tumor. The thermal energy stored in a few drops of water is released into the cancerous cells as the vapor condenses back to its liquid state and the steam destroys them. 

The device is similar to Boston Scientific’s Rezum water vapor therapy, which was FDA-approved in 2015 to relieve symptoms, obstructions, and reduce prostate tissue associated with benign prostatic hyperplasia. The Vanquish system received FDA 510(k) clearance using Rezum as a predicate device. 

It will be competing with many other prostate cancer focal therapies, which target a part of the prostate to try to reduce the risk for urinary leakage and sexual dysfunction, common side effects with surgery and radiation. Focal therapies include high-intensity focused ultrasound (HIFU), cryotherapy, irreversible electroporation, transurethral ultrasound ablation, and laser ablation. 

Schade said a potential advantage of using steam is that it does not typically penetrate through the capsule of the prostate, which helps minimize the risk for damage of other tissues. It may also be able to target tumors in the front of the prostate, which are hard to reach with transrectal HIFU.

“What we see from this data is a really strong signal,” George said. But a year studying 110 patients is not sufficient “to be able to understand its full potential and even limitations in the setting of management of prostate cancer,” he added.

The Vapor 2 study was funded by Francis Medical. George reported being a paid speaker/consultant/principal investigator for Angiodynamics, Francis Medical, Wasatch Medical, and Sonablate. Schade reported being a consultant for Focal One and Petal Surgical, and to have an intellectual property license to Petal Surgical. Weiner reported no relevant financial conflicts of interest. 

https://www.medscape.com/viewarticle/new-device-uses-steam-kill-prostate-cancer-2025a1000yeb