Pilot Study on Focal Prostate Radio-Frequency Ablation

November 13, 2013 updated by: H. Lee Moffitt Cancer Center and Research Institute

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

This is a prospective pilot study. 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 Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

5

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Procedure: Radio-Frequency Ablation (RFA) 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.
Other Names:
  • ENCAGE™

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Negative Prostate Biopsy Rate at Six Months
Time Frame: 6 Months
The primary efficacy endpoint is negative biopsy rate at 6 months after focal bipolar RFA. Evaluable patients for this study will be those who complete up through the six month follow-up/evaluation procedure.
6 Months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Completion of Quality of Life (QOL) Assessment Questionnaires at Six Months
Time Frame: 6 Months
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 month and 6 month visits. QOL will be primarily based on the EPIC, developed to measure health related QOL among men with prostate cancer.
6 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

H. Lee Moffitt Cancer Center and Research Institute

Collaborators

Trod Medical, US,LLC

Investigators

  • Principal Investigator: Julio Pow-Sang, M.D., H. Lee Moffitt Cancer Center and Research Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2011

Primary Completion (Actual)

March 1, 2013

Study Completion (Actual)

March 1, 2013

Study Registration Dates

First Submitted

August 23, 2011

First Submitted That Met QC Criteria

August 24, 2011

First Posted (Estimate)

August 25, 2011

Study Record Updates

Last Update Posted (Estimate)

November 14, 2013

Last Update Submitted That Met QC Criteria

November 13, 2013

Last Verified

November 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MCC-16584

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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