Back to resultsFocal Prostate Radio-Frequency Ablation
Primary Purpose
Prostate Cancer
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Radio-Frequency Ablation (RFA)
Sponsored by
About this trial
This is an interventional treatment trial for Prostate Cancer focused on measuring adenocarcinoma, prostate, ENCAGE™, focal bipolar radiofrequency ablation, radiofrequency ablation (RFA), radiotherapy
Eligibility Criteria
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
Sites / Locations
- H. Lee Moffitt Cancer Center and Research Institute
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Radio-Frequency Ablation (RFA)
Arm Description
Focal Prostate Radio-Frequency Ablation (RFA). Focal bipolar RFA followed by clinical follow-up visits at 6 weeks, 3 months and 6 months.
Outcomes
Primary Outcome Measures
Negative Biopsy Rate at 6 Months After Focal Bipolar Radio-Frequency Ablation (RFA)
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
Number of Participants With Treatment Related Adverse Events
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.
Completion of Quality of Life (QOL) Assessment Questionnaires at Six 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. EPIC scores overall 1 (dissatisfied) - 5 (extremely satisfied). AUA scores are o (no prostate issues) - 35 (very severe prostate symptoms). SHIM scores 0 (severe sexual dysfunction) - 25 (no sexual dysfunction) and RAS scores 0 (no bowel issues) - 15 (bad bowel habits)
Full Information
NCT ID
NCT02328807
First Posted
December 29, 2014
Last Updated
August 5, 2021
Sponsor
H. Lee Moffitt Cancer Center and Research Institute
Collaborators
Trod Medical N.V.
1. Study Identification
Unique Protocol Identification Number
NCT02328807
Brief Title
Focal Prostate Radio-Frequency Ablation
Official Title
Focal Prostate Radio-Frequency Ablation for the Treatment of Prostate Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
December 29, 2014 (Actual)
Primary Completion Date
May 10, 2018 (Actual)
Study Completion Date
July 8, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
H. Lee Moffitt Cancer Center and Research Institute
Collaborators
Trod Medical N.V.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
adenocarcinoma, prostate, ENCAGE™, focal bipolar radiofrequency ablation, radiofrequency ablation (RFA), radiotherapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
6 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Radio-Frequency Ablation (RFA)
Arm Type
Experimental
Arm Description
Focal Prostate Radio-Frequency Ablation (RFA). Focal bipolar RFA followed by clinical follow-up visits at 6 weeks, 3 months and 6 months.
Intervention Type
Procedure
Intervention Name(s)
Radio-Frequency Ablation (RFA)
Other Intervention Name(s)
ENCAGE™
Intervention 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.
Primary Outcome Measure Information:
Title
Negative Biopsy Rate at 6 Months After Focal Bipolar Radio-Frequency Ablation (RFA)
Description
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.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Number of Participants With Treatment Related Adverse Events
Description
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.
Time Frame
Up to 9 months
Title
Completion of Quality of Life (QOL) Assessment Questionnaires at Six Months
Description
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. EPIC scores overall 1 (dissatisfied) - 5 (extremely satisfied). AUA scores are o (no prostate issues) - 35 (very severe prostate symptoms). SHIM scores 0 (severe sexual dysfunction) - 25 (no sexual dysfunction) and RAS scores 0 (no bowel issues) - 15 (bad bowel habits)
Time Frame
6 months
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Julio Pow-Sang, M.D.
Organizational Affiliation
H. Lee Moffitt Cancer Center and Research Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
H. Lee Moffitt Cancer Center and Research Institute
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Focal Prostate Radio-Frequency Ablation
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