Unilateral Nerve-Sparing Cryoablation for Low-Risk, Clinically Localized, Unilateral Prostate Cancer in Potent Men: A Prospective, Phase II Trial
This study is a clinical trial to determine and assess the change in the rate of potency in men with low-risk, localized, unilateral prostate cancer who have not received previous treatment. A total of 86 men between 40 to 69 years of age with biopsy proven, early stage localized prostate cancer will receive unilateral nerve-sparing cryoablation. The study includes a screening/pre-operative visit, a cryoablation procedure day, and 10 follow up visits with completion of validated questionnaires over the course of 36 months. The first follow-up visit will occur within 2 weeks (±1 week) after cryoablation. Thereafter, follow-up visits will be scheduled, from the date of procedure, every 3 months (±3 weeks) for 18 months and every 6 months (±3 weeks) thereafter until the patient completes the protocol, 36 months after the cryoablation procedure. Cryoablation is an FDA-approved and accepted treatment for prostate cancer. The potential benefits of this study include better preservation of potency, continence and health related quality of life compared to other treatment options.