Focal Prostate Radio-Frequency Ablation

Not Applicable

Completed

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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Radio-Frequency Ablation (RFA)	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.

Primary Outcome Measures

Name	Time	Method
Negative Biopsy Rate at 6 Months After Focal Bipolar Radio-Frequency Ablation (RFA)	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

Name	Time	Method
Completion of Quality of Life (QOL) Assessment Questionnaires at Six Months	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. 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)
Number of Participants With Treatment Related Adverse Events	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.