Pilot Study on Focal Prostate Radio-Frequency Ablation
The purpose of this research study is to evaluate the safety and efficacy of focal Radio-Frequency Ablation (RFA) in men with low-risk, clinically localized prostate cancer.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Pilot Study on Focal Prostate Radio-Frequency Ablation for the Treatment of Very-Low Risk Prostate Cancer|
- Number of Participants With Desired Effect From Treatment [ Time Frame: 6 Months Per Participant ] [ Designated as safety issue: No ]Descriptive statistics will be used to summarize patients' demographic and clinical characteristics collected at each visit. Mean, standard deviation and range will be calculated for continuous variables, and frequency and percentage will be generated for categorical variables. The primary objective is to assess the local oncologic efficacy of focal RFA in men with low-risk prostate cancer. The primary efficacy endpoint is negative biopsy rate at 6 months after focal bipolar RFA.
- Number of Participants Quality of Life (QOL) Changes [ Time Frame: 6 Months Per Participant ] [ Designated as safety issue: No ]Evaluate the change from baseline in quality-of-life indicators following focal RFA in patients with low-risk localized prostate cancer. Patients will complete the Expanded Prostate Cancer Index Composite (EPIC), American Urologic (AUA), Rectal Assessment Scale (RAS), and Sexual Health Inventory for Men (SHIM) questionnaires at baseline, 3- and 6-month visit. QOL will be primarily based on the EPIC, developed to measure health related QOL among men with prostate cancer.
- Number of Participants With Adverse Events [ Time Frame: 6 Months Per Participant ] [ Designated as safety issue: Yes ]For safety analyses, adverse event will be summarized by worst National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.0 grade and serious adverse event will be listed separately. Safety data, such as toxicity and laboratory test, will be summarized by time point of collection. Descriptive statistics will be calculated for quantitative safety data and frequency counts will be summarized for classifications of qualitative safety data.
|Study Start Date:||August 2011|
|Study Completion Date:||March 2013|
|Primary Completion Date:||November 2012 (Final data collection date for primary outcome measure)|
Experimental: Focal Prostate Radio-Frequency Ablation
Treatment is performed under a spinal or general anesthetic and will include the one to three regions of the prostate containing cancer based on the mapping biopsy.
Device: Radio-Frequency Ablation (RFA) ENCAGE™
Treatment is performed under a spinal or general anesthetic and will include the one to three regions of the prostate containing cancer based on the mapping biopsy. Additional information is provided in the Detailed Description.
Other Name: ENCAGE™
RFA is a minimally invasive procedure. It is an image-guided technique that heats and destroys cancer cells. In RFA, imaging techniques such as ultrasound or magnetic resonance imaging (MRI) are used to help guide a needle electrode into a cancerous tumor. High-frequency electrical currents are then passed through the electrode, destroying the cancer cells. Use of an RFA device was approved by the Food and Drug Association (FDA) in 1997 for the purposes of treating soft tissue tumors. The device we (Moffitt Cancer Center) will be using in this study has clearance for clinical use from the FDA. The effectiveness of the device is measured using biopsy cores at the site of the cancer after the RFA procedure. To evaluate the benefits of this procedure, we will also evaluate the change in quality-of-life indicators from baseline to 6 months following RFA. RFA is being developed as a minimally invasive potential treatment for prostate cancer.
This research study is a pilot clinical trial. Pilot clinical trials are smaller versions of larger studies that are conducted to prepare for the larger study. This pilot study pre-tests a research device before a large-scale multicenter study is launched.
The specific purpose of this pilot trial is to find out if RFA can effectively treat prostate cancer with fewer side effects including effects on urination, bowel function, and sexual function. RFA for early stage prostate cancer is designed to affect only the part of the prostate where cancer has been detected. The reasoning for this approach is the smaller the area given RFA, the less damage to surrounding tissues.
|United States, Florida|
|H. Lee Moffitt Cancer Center and Research Institute|
|Tampa, Florida, United States, 33612|
|Principal Investigator:||Julio Pow-Sang, M.D.||H. Lee Moffitt Cancer Center and Research Institute|