Water Vapor Ablation for Localized Intermediate Risk Prostate Cancer

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.