Focal Laser Ablation of Low to Intermediate Prostate Cancer Tumors

A Pilot Study to Evaluate Magnetic Resonance Thermal Image-Guided Focal Laser Ablation of Prostate Cancer Tumors

The primary purpose of this study is to evaluate the feasibility and safety of MRI-guided focal laser ablation (Laser-Induced Interstitial Thermal Therapy, LITT) to treat low-risk native prostate cancer.

The study is being done to evaluate the safety and effectiveness of Magnetic Resonance Imaging (MRI)-guided focal laser therapy with the Visualase Thermal Therapy System to treat low-risk prostate cancer tumors. Unlike surgery or radiotherapy which affects a large portion of the prostate or the entire organ, localized or focal therapy is intended to treat a small portion of tissue in which the cancer has been found by biopsy.

Inclusion Criteria

• Male, 45 years of age or older.
• Diagnosis of prostate adenocarcinoma.
• Clinical stage T1c or T2a.
• Gleason score of 7 (3+4 or 4+3) or Intermediate risk Gleason 6
• PSA less than or equal to 20 ng/mL
• Three or fewer biopsy locations with prostate cancer which correlate with MRI findings.
• No lesion > or = 2cm
• One, two, or three tumor suspicious regions identified on multiparametric MRI
• No definite radiographic indication of extra-capsular extension.
• Estimated survival of 5 years or greater, as determined by treating physician.
• Tolerance for anesthesia/sedation.
• Ability to give informed consent.

Exclusion Criteria

• Presence of any condition (e.g., metal implant, shrapnel) not compatible with MRI.
• History of other primary non-skin malignancy within previous three years.