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Steam power: new device aims to zap prostate cancer without major side effects

NCT ID NCT05683691

Disease control Sponsor: Francis Medical Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests a device called Vanquish that uses water vapor (steam) to destroy prostate cancer tissue in men with intermediate-risk, localized prostate cancer. The goal is to control the cancer while avoiding common side effects like incontinence and impotence. About 400 men aged 50 and older are taking part across multiple centers.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
water vapor ablation (Vanquish System)
What this could lead to
If successful, this could offer a less invasive treatment option for intermediate-risk prostate cancer that controls the disease while reducing side effects like incontinence and impotence.
What could go wrong
This is an early-stage, single-arm study with no comparison group, so results may not be definitive. The treatment may not fully control the cancer, and risks like infection or urinary issues remain possible.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 400 people

The number the study aims to enrol. It can still change while the study runs.

Started

May 2023

Expected to finish

Apr 2029

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

50 years and older

Sex

Male participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. ≥50 years of age; with life expectancy of ≥10 years 2. 20-80 cc prostate size determined by MRI Central Imaging 3. ≤15 ng/ml PSA 4. Cancer stage less than or equal to T2c 5. Within 12 months prior to signing consent have had a multiparametric MRI. Within 6 months prior to signing consent, have undergone a multiparametric MRI software guided fusion biopsy of the prostate (transrectal or transperineal). This must include a standard sector biopsy obtaining a minimum of 10 cores. * \<15mm diameter of qualifying lesion as measure by greatest diameter 6. Subject is willing and able to adhere to specific protocol visits and required testing throughout study 7. Is geographically stable and near the site or able and willing to travel back to site for follow-up visits involving diagnostic tests or treatment 8. Able and willing to provide written consent to participate in the study. 9. Subject is willing and able to be treated within 180 days after signing consent. Exclusion Criteria: 1. Patients with \>GGG3 cores anywhere in the prostate 2. MRI evidence of extracapsular extension of cancer (MRI read as "definite", "frank" or "gross" ECE) 3. All MRI Central Imaging confirmed PI-RADS 5 lesions 4. All MRI Central Imaging confirmed additional PI-RADS 4 lesions. 5. Contraindications to MRI 6. Subjects with an installed pacemaker or other potentially electrically conductive implants implanted within 200mm (8 inches) of the procedure area. Implants that are within 200mm (8 inches) and can be turned off for the duration of the study procedure are acceptable. 7. Any prior surgery, intervention, or minimally invasive therapy, (MIST) for the prostate cancer or bladder neck. 8. Treated within the past 5 years for genital cancer 9. Presence of any urethral or prostatic condition that precludes water vapor ablation per Instructions for Use 10. Currently taking medications that have hormonal effects on the prostate or PSA, such as: 5 alpha reductase inhibitors (if on for \<6 months, 6-month washout), Androgen blockers, Luteinizing hormone-releasing hormone (LHRH) agonists or antagonists (12-month washout), or Testosterone supplementation (3-month washout) 11. Active urinary tract infection. Subjects with an active infection who can be treated and re-tested with a negative result within the screening window are acceptable. 12. Active or clinically chronic prostatitis or granulomatous prostatitis 13. Treated within the past 5 years for a lower and/or upper urinary tract malignancy. 14. Any previous treatment for prostate cancer. 15. Any rectal pathology, anomaly or previous treatment that could change properties of rectal wall or insertion and use of TRUS 16. Unable to stop taking antiplatelet medications or other blood thinning agents 17. Known allergy to nickel 18. Allergic to medication required by the study such as MRI contrast or anesthesia 19. Any significant medical history that would pose an unreasonable risk or make the subject unsuitable for the study 20. Any cognitive or psychiatric condition that interferes with or precludes direct and accurate communication with the study Investigator regarding the study or affects the ability to complete the study quality of life questionnaires 21. Subject currently participating in other premarket investigational studies unless approved by Sponsor in writing 22. Subject is considered vulnerable such as incarcerated or cognitively impaired.

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Conditions

The condition(s) this trial relates to.

prostate cancer prostate carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Prostate cancer

Contacts and locations

Locations

  • Carolina Urologic Research Center

    Myrtle Beach, South Carolina, 29572, United States

  • Chesapeake Urology

    Baltimore, Maryland, 21204, United States

  • Corewell Health / William Beaumont University Hospital

    Royal Oak, Michigan, 48073, United States

  • Duke Cancer Institute

    Durham, North Carolina, 27710, United States

  • Houston Methodist Hospital and Research Institute

    Houston, Texas, 77030, United States

  • Johns Hopkins

    Baltimore, Maryland, 21287, United States

  • Kasraeian Urology

    Jacksonville, Florida, 32216, United States

  • Mayo Clinic- Phoenix

    Phoenix, Arizona, 85054, United States

  • Mayo Clinic- Rochester

    Rochester, Minnesota, 55905, United States

  • Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226, United States

  • Memorial Care

    Laguna Hills, California, 92653, United States

  • Michigan Institute of Urology

    Troy, Michigan, 48084, United States

  • MidLantic Urology

    Bala-Cynwyd, Pennsylvania, 19004, United States

  • Minnesota Urology

    Woodbury, Minnesota, 55125, United States

  • NYU Langone Health

    New York, New York, 10016, United States

  • Northwell Health- Lenox Hill Hospital

    New York, New York, 11222, United States

  • The Urology Group

    Cincinnati, Ohio, 45212, United States

  • The Urology Place

    San Antonio, Texas, 78240, United States

  • University of Chicago

    Chicago, Illinois, 60637, United States

  • University of Minnesota

    Minneapolis, Minnesota, 55454, United States

  • University of Rochester

    Rochester, New York, 14620, United States

  • University of Southern California

    Los Angeles, California, 90089, United States

  • Urology Austin

    Austin, Texas, 78745, United States

  • Urology of Virginia, PLLC

    Virginia Beach, Virginia, 23462, United States

  • Wichita Urology

    Wichita, Kansas, 67226, United States

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