Focal Prostate Radio-Frequency Ablation

Study Overview
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Brief Summary
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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.

Official Title
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Focal Prostate Radio-Frequency Ablation for the Treatment of Prostate Cancer

Conditions
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Prostate Cancer

Intervention / Treatment
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* Procedure: Radio-Frequency Ablation (RFA)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Radio-Frequency Ablation (RFA)<br>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)<br>* 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.<br>* Other names: ENCAGE™;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Up to 9 months | 
| 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) | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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adenocarcinoma, prostate, ENCAGE™, focal bipolar radiofrequency ablation, radiofrequency ablation (RFA), radiotherapy