MRI Guided Focal Laser Ablation of Prostate Cancer
This clinical research study is designed to determine the ability of in bore MRI guided Focal Laser Ablation (MRgFLA) in patients with early stage carcinoma of prostate. The results will be evaluated by repeated MRI and prostate biopsy. Previous prospective development study demonstrated that FLA may be a viable option for men with low-intermediate risk prostate cancer. The vast majority of patients undergoing this treatment experienced minimal side effects with no peri-operative complications. Over 80% of patients treated with MRgFLA remain on AS and were able to avoid radical therapy at mean follow up duration of 3 years.
• Men 40-80 years of age
• Histologically proven low-intermediate risk prostate carcinoma; (Gleason score ≤ 7, primary grade ≤ 4;)
• Prostate cancer clinical stage T1c and T2
• MR site suspicious for cancer or cancer mapped to one lobe of the prostate using the 3D hybrid TRUS device
• Size of MR visible tumor \<20mm
• Suspicious site on Prostate MRI must coincide with sector positive for cancer on biopsy
• Prostate specific antigen (PSA) level \<15 ng/mL
• IPSS, ICIQ-UI-SF, IIEF complete prior to procedure
• Life expectancy of greater than 10 years, based on co-morbidity not related to prostate cancer.