Investigator Initiated Trial to Further Evaluate the Safety and Efficacy of Trans-perineal Focal Laser Ablation of Localized Prostate Cancer Using High Frequency Micro-ultrasound Imaging

Who can take part

• Men between the ages of 40 and 85 years
• Ability to read, understand and agree/sign the patient informed consent in the English language
• Serum PSA < 20 ng/ml
• AJCC clinical tumor stage T2b or less (according to digital rectal examination)
• Men with localized PCa (GG 1or 2, Gleason Score 7 or less) (Low or Favorable Intermediate Risk PCa) with an MR-image detected index lesion done within three months from the time of enrollment and visible on micro-ultrasound
• According to the decision of the investigator:; Patient is suitable to undergo treatment with FLA; Able to tolerate a procedure under local anesthesia; Able to undergo Nitrous Oxide sedation; Able to undergo MR; has normal rectal anatomy
• Lesion Specificity:; Unilateral, with cumulative lesion volumes not comprising more than 50 percent of the lobe as determined by MRI; Lesion distances from the outer perimeter of the energy emitting zone of the diffuser to adjacent vital structures (bladder wall, rectal wall, neurovascular bundles, and urethra) must be ≥ 8mm
• Minimum distance to rectal wall and other sensitive structures ≥ 8mm

Who cannot take part

• Previous prostate surgery
• Anticoagulant therapy
• Prior or ongoing PCa treatment including surgery, radiation therapy, hormonal therapy or focal therapy
• Previous radiation of the pelvic region
• Patients with recurrent prostate cancer
• Gleason Grade Group 3 PCa or higher
• Multifocal PCa other than Gleason Grade Group 1
• Locally advanced or metastatic PCa
• Intraprostatic calculus > 5mm
• Inability to tolerate a dorsal lithotomy position under Nitrous Oxide sedation for > 90 minutes
• ECOG Status ≥2
• Urethral Stenosis
• Prostate height > 5 cm anterior to posterior or a prostate volume >100 cc's