Focal Laser Ablation of Prostate Cancer Tumors

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 less.

- Three or fewer biopsy cores with prostate cancer.

- No single biopsy core with greater than 50% of tumor involvement.

- One, two, or three tumor suspicious regions identified on multiparametric MRI

- Negative radiographic indication of extra-capsular extent.

- A documented Karnofsky performance status of at least 70.

- Estimated survival of 5 years or greater, as determined by treating physician.

- Tolerance for anesthesia/sedation.

- Ability to give informed consent.

- MR-guided biopsy confirmation of one or more radiographically visible prostate
lesion(s) with Gleason score of 7 (3+4 or 4+3) or less.

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.