Micro-ultrasound-Guided Focal Laser Ablation (MicroUSgFLA) Treatment for Management of Intermediate-Risk Prostate Cancer: Evaluation of Safety and Effectiveness
This clinical research study is intended to show that Micro-Ultrasound Guided Focal Laser Ablation (MicroUSgFLA) is a safe procedure that can significantly postpone or eliminate the need for patients with intermediate-Risk prostate cancer (PCa) to undergo a definitive treatment (i.e., Radical Prostatectomy or Radiation Therapy) for their disease.
• Men 40-80 years of age.
• Histologically-proven intermediate-risk PCa (Gleason score 7, primary grade ≤ 4).
• PCa clinical stage T1c or T2.
• MRI/MicroUS site suspicious for cancer or cancer mapped to one prostate lobe.
• Maximum dimension of MRI/MicroUS visible tumour ≤15mm.
• Suspicious site on Prostate MRI/MicroUS must coincide with sector positive for cancer on biopsy.
• Prostate specific antigen (PSA) level \< 15 ng/mL.
• IPSS, ICIQ-UI-SF, IIEF-15 questionnaires completed prior to the procedure.
• Life expectancy of greater than 10 years, based on co-morbidity not related to PCa.