Unilateral Nerve-Sparing Cryoablation for Low-Risk, Clinically Localized, Unilateral Prostate Cancer — POTENT-C  

Prostate Cancer Clinical Trial

Official title: Unilateral Nerve-Sparing Cryoablation for Low-Risk, Clinically Localized, Unilateral Prostate Cancer in Potent Men: A Prospective, Phase II Trial

Status Terminated

Clinical Trial Summary

Men with low-risk, clinically localized, unilateral prostate cancer will be treated with unilateral nerve-sparing cryoablation and evaluated for the rate of potency, cancer control and health related quality of life outcomes after treatment.

Clinical Trial 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. 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. ;

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

• NCT number: NCT02459912
• Study type: Interventional
• Source: New York University School of Medicine
• Status: Terminated
• Phase: Phase 2
• Start date: April 2015
• Completion date: April 26, 2018