Pilot Study on Focal Prostate Radio-Frequency Ablation for the Treatment of Very-Low Risk Prostate Cancer
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.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Number of Participants With Desired Effect From Treatment
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.
6 Months Per Participant
Julio Pow-Sang, M.D.
H. Lee Moffitt Cancer Center and Research Institute
United States: Food and Drug Administration
|H. Lee Moffitt Cancer Center and Research Institute||Tampa, Florida 33612|