|Title||Unilateral Nerve-Sparing Cryoablation for Low-Risk, Clinically Localized, Unilateral Prostate Cancer in Potent Men: A Prospective, Phase II Trial (POTENT-C)|
|Description||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. 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.
As part of this clinical trial, 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 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. The potential risks of cryoablation in the early post-operative period include pain (3-26%), infection (9%), bleeding (5%), bruising (common) delayed wound healing (<1%), swelling (5-18%), transient penile numbness (2-15%), hematuria (5%), transient urinary retention (1.5-13%), or erectile dysfunction (87-93%). Delayed risks include impotence, urinary incontinence (3-9%), urinary stricture (5%), urethral sloughing (5%), pelvic pain, urethral stricture (5%), and failure to control cancer.
|Inclusion/Notes||Men who have been diagnosed with early, low-risk prostate cancer located on only one side of the prostate and have not had any previous treatment for the disease.|