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Pilot Study on Focal Prostate Radio-Frequency Ablation for the Treatment of Very-Low Risk Prostate Cancer

18 Years
Not Enrolling
Prostate Cancer

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Trial Information

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.

Inclusion Criteria:

- Diagnosis of adenocarcinoma of the prostate, confirmed by H.L. Moffitt Cancer Center

- No prior treatment for prostate cancer including hormonal therapy

- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

- Prostate Cancer Clinical Stage T1c

- prostate-specific antigen (PSA) <10 ng/ml (this will be the PSA level prompting the
initial prostate biopsy)

- Prostate size <60 cc on transrectal ultrasound

- If on anti-coagulation medications, must be able to suspend this therapy for a couple
of weeks

- Adequate organ function Pre-enrollment biopsy parameters (as per H.L. Moffitt Cancer
Center review)

- Minimum of 10 biopsy cores

- No biopsy Gleason grade 4 or 5

- Unilateral cancer (only right-sided or left-sided, not bilateral)

- No more than 50% cancer in any one biopsy core

- No more than 25% of cores containing cancer

Exclusion Criteria:

- Medically unfit for anesthesia

- Histology other than adenocarcinoma

- Biopsy does not meet inclusion criteria

- Men who have received any hormonal manipulation (antiandrogens; luteinizing
hormone-releasing hormone (LHRH) agonist; 5-alpha-reductase inhibitors) within the
previous 6 months

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Number of Participants With Desired Effect From Treatment

Outcome Description:

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.

Outcome Time Frame:

6 Months Per Participant

Safety Issue:


Principal Investigator

Julio Pow-Sang, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

H. Lee Moffitt Cancer Center and Research Institute


United States: Food and Drug Administration

Study ID:




Start Date:

August 2011

Completion Date:

March 2013

Related Keywords:

  • Prostate Cancer
  • Pilot
  • Ablation
  • Low Risk
  • Radio Frequency
  • RFA
  • minimally invasive
  • prostate gland
  • Prostatic Neoplasms



H. Lee Moffitt Cancer Center and Research Institute Tampa, Florida  33612