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.
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
