Focal Prostate Radio-Frequency Ablation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02328807
Recruitment Status : Active, not recruiting
First Posted : December 31, 2014
Last Update Posted : May 11, 2018
Trod Medical N.V.
Information provided by (Responsible Party):
H. Lee Moffitt Cancer Center and Research Institute

Brief Summary:
The main purpose of this study is to evaluate the safety and efficacy of focal (targeted) Radio-Frequency Ablation (RFA) in men with low or intermediate-risk, clinically localized prostate cancer.

Condition or disease Intervention/treatment Phase
Prostate Cancer Procedure: Radio-Frequency Ablation (RFA) Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 6 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Focal Prostate Radio-Frequency Ablation for the Treatment of Prostate Cancer
Actual Study Start Date : December 29, 2014
Estimated Primary Completion Date : April 2019
Estimated Study Completion Date : April 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arm Intervention/treatment
Experimental: Radio-Frequency Ablation (RFA)
Focal Prostate Radio-Frequency Ablation (RFA). Focal bipolar RFA followed by clinical follow-up visits at 6 weeks, 3 months and 6 months.
Procedure: Radio-Frequency Ablation (RFA)
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™

Primary Outcome Measures :
  1. Negative Biopsy Rate at 6 Months [ Time Frame: 6 months ]
    The primary efficacy endpoint is negative biopsy rate at 6 months after focal bipolar RFA. The point estimate and its 95% confidence interval will be calculated using the exact binominal method.

Secondary Outcome Measures :
  1. Number of Participants with Adverse Events [ Time Frame: Up to 9 months ]
    The type of event using NCI Common Toxicity Criteria for Adverse Events (CTCAE) version 4.0 will be identified and graded for severity. The relationship of the adverse event to the therapy or procedure will be determined as follows: Unrelated; Unlikely; Possible; Probable; Definite. For reporting purposes, an adverse event is considered unexpected when either the type of event or severity of the event is not listed in the study consent.

  2. Completion of Quality of Life (QOL) Assessment Questionnaires at Six Months [ Time Frame: 6 months ]
    The secondary objective is to evaluate the change from baseline in quality-of-life indicators following focal RFA in patients with low-risk localized prostate cancer. The patients will complete the Expanded Prostate Cancer Index Composite (EPIC), American Urological Association (AUA), Rectal Assessment Scale (RAS), and International Index of Erectile Function (IIEF-5) questionnaires at baseline and 6-month visit. The QOL will be primarily based on the EPIC, developed to measure health related quality of life among men with prostate cancer. The EPIC assesses the disease-specific aspects of prostate cancer and its therapies and comprises four summary domains (Urinary, Bowel, Sexual and Hormonal) [Wei et al, 2000]. The EPIC summary score and subscale characteristics at each time-point will be calculated based on its scoring instruction.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Men 18 years of age or older
  • Diagnosis of adenocarcinoma of the prostate, confirmed by H.L. Moffitt Cancer Center review
  • No prior treatment for prostate cancer
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or1
  • Prostate Cancer Clinical Stage T2a and below
  • PSA <10 ng/ml (this will be the prostatic specific antigen (PSA) level prompting the initial prostate biopsy)
  • Prostate size <60 cc on transrectal ultrasound
  • Pre-enrollment biopsy parameters (as per H.L. Moffitt C.C. review): Minimum of 10 biopsy cores; Gleason score 6 aor 7; Unilateral cancer (only right-sided or left-sided, not bilateral).

Exclusion Criteria:

  • Men less than 18 years of age
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02328807

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

Additional Information:
Responsible Party: H. Lee Moffitt Cancer Center and Research Institute Identifier: NCT02328807     History of Changes
Other Study ID Numbers: MCC-17753
First Posted: December 31, 2014    Key Record Dates
Last Update Posted: May 11, 2018
Last Verified: May 2018

Studies a U.S. FDA-regulated Drug Product: No

Keywords provided by H. Lee Moffitt Cancer Center and Research Institute:
focal bipolar radiofrequency ablation
radiofrequency ablation (RFA)

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