MedTrace Logo

MRI-Targeted Focal Ablation of the Prostate in Men With Prostate Cancer

NCT02303054 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 21

Last updated 2017-10-11

No results posted yet for this study

Summary

This is a prospective single center trial to examine the rate of negative biopsy result and quality of life after focal ablation by radiofrequency energy. The primary evaluation involves assessing the rate of negative biopsy result using MR-US fusion biopsy six months after focal ablation of the prostate. Urinary and sexual quality of life will be assessed through validated measures. The hypothesis of our study is that focal ablative therapy will result in a greater likelihood of negative biopsy on followup biopsy than that observed in men who elect not to undergo therapy.

Conditions

Interventions

PROCEDURE

Bipolar Radiofrequency Focal Ablation

Men identified as having suspicious regions on a pre-biopsy mpMRI will be considered for enrollment. Following an MRI-US targeted biopsy of the prostate, men testing positive will be eligible for enrollment. All men enrolled in the study will undergo focal radiofrequency ablation and evaluated in follow-up.

Sponsors & Collaborators

Principal Investigators

  • Samir S Taneja, MD · NYU Langone Health

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
40 Years
Max Age
80 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-09-30
Primary Completion
2016-03-31
Completion
2016-03-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02303054 on ClinicalTrials.gov