Water Vapor Ablation for Localized Intermediate Risk Prostate Cancer

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 6months prior to signing consent, have undergone a multiparametric MRI softwareguided fusion biopsy of the prostate (transrectal or transperineal). This mustinclude 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 requiredtesting throughout study

7. Is geographically stable and near the site or able and willing to travel back tosite 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 conductiveimplants implanted within 200mm (8 inches) of the procedure area. Implants that arewithin 200mm (8 inches) and can be turned off for the duration of the studyprocedure are acceptable.

7. Any prior surgery, intervention, or minimally invasive therapy, (MIST) for theprostate 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 ablationper Instructions for Use

10. Currently taking medications that have hormonal effects on the prostate or PSA, suchas: 5 alpha reductase inhibitors (if on for <6 months, 6-month washout), Androgenblockers, 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 treatedand 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 ofrectal 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 thesubject unsuitable for the study

20. Any cognitive or psychiatric condition that interferes with or precludes direct andaccurate communication with the study Investigator regarding the study or affectsthe ability to complete the study quality of life questionnaires

21. Subject currently participating in other premarket investigational studies unlessapproved by Sponsor in writing

22. Subject is considered vulnerable such as incarcerated or cognitively impaired.