Ensayos clínicos

Inclusion Criteria:

• ≥ 50 years of age; with life expectancy of ≥ 10 years.
• 20-80 cc prostate size measured by MRI.
• ≤ 15 ng/ml PSA.
• Cancer stage less than or equal to T2c.
• Within 6 months of 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 12-16 cores.
• ≤ 15mm diameter of lesion as measure by greatest diameter.
• Subject is willing and able to adhere to specific protocol visits and required testing throughout study.
• 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.
• Able and willing to provide written consent to participate in the study.

Exclusion Criteria:

• MRI evidence of extracapsular extension of cancer (MRI read as "definite", "frank" or "gross" ECE).
• Contraindications to MRI.
• 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.
• Any prior surgery, intervention, or minimally invasive therapy, (MIST) for the prostate cancer or bladder neck.
• Treated within the last 5 years for genital cancer.
• Presence of any urethral or prostatic condition that precludes water vapor ablation per Instructions for Use.
• Currently taking medications that have hormonal effects on the prostate or PSA, such as: 5 alpha reductase inhibitors (if on for < 6 months), Androgen blockers, Luteinizing hormone-releasing hormone (LHRH) agonists or antagonists (12 month wash-out), or Testosterone supplementation.
• Active urinary tract infection.
• Active or clinically chronic prostatitis or granulomatous prostatitis.
• Active lower and upper urinary tract malignancy (excluding prostate cancer meeting the inclusion criteria).
• Any rectal pathology, anomaly or previous treatment that could change properties of rectal wall or insertion and use of TRUS.
• Unable to stop taking antiplatelet medications or other blood thinning agents.
• Known allergy to nickel.
• Alergic to medication required by the study such as MRI contrast or anesthesia.
• Any significant medical history that would pose an unreasonable risk or make the subject unsuitable for the study.
• 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.
• Subject currently participating in other premarket investigational studies unless approved by Sponsor in writing.
• Subject is considered vulnerable such as incarcerated or cognitively impaired.

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 12//27/03. Questions regarding updates should be directed to the study team contact.