Pilot Study on Focal Prostate Radio-Frequency Ablation

This study has been completed.
Sponsor:
Collaborator:
Trod Medical, US,LLC
Information provided by (Responsible Party):
H. Lee Moffitt Cancer Center and Research Institute
ClinicalTrials.gov Identifier:
NCT01423006
First received: August 23, 2011
Last updated: November 13, 2013
Last verified: November 2013
  Purpose

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.


Condition Intervention
Prostate Cancer
Procedure: Radio-Frequency Ablation (RFA) ENCAGE™

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by H. Lee Moffitt Cancer Center and Research Institute:

Primary Outcome Measures:
  • Negative Prostate Biopsy Rate at Six Months [ Time Frame: 6 Months ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Completion of Quality of Life (QOL) Assessment Questionnaires at Six Months [ Time Frame: 6 Months ] [ Designated as safety issue: No ]
    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.


Enrollment: 5
Study Start Date: August 2011
Study Completion Date: March 2013
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: ENCAGE™

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01423006

Locations
United States, Florida
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, United States, 33612
Sponsors and Collaborators
H. Lee Moffitt Cancer Center and Research Institute
Trod Medical, US,LLC
Investigators
Principal Investigator: Julio Pow-Sang, M.D. H. Lee Moffitt Cancer Center and Research Institute
  More Information

No publications provided

Responsible Party: H. Lee Moffitt Cancer Center and Research Institute
ClinicalTrials.gov Identifier: NCT01423006     History of Changes
Other Study ID Numbers: MCC-16584
Study First Received: August 23, 2011
Last Updated: November 13, 2013
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by H. Lee Moffitt Cancer Center and Research Institute:
Pilot
Ablation
Low Risk
Radio Frequency
RFA
minimally invasive
prostate gland

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases

ClinicalTrials.gov processed this record on August 28, 2014