Dynamic Focusing Evaluation for Prostate Cancer Treatment

Evaluation of a Dynamic Focusing Ultrasonic Transducer for High Intensity Focused Ultrasound (HIFU) Treatment of Localized Prostate Adenocarcinoma - Dose Escalation Trial to Define the Best Acoustic Parameters

Define the best acoustic parameters for the dynamic focusing HIFU transducer in the treatment of localized Prostate Cancer.

Inclusion Criteria for primary care patients:

• Age > 70 years
• T1 or T2
• PSA < 15 ng/mL
• 12 randomized biopsies
• Gleason score ≤ 3+4
• Normal anal and rectal anatomy
• American Society of Anesthesiologists risk (ASA) 1 or 2

Exclusion Criteria for primary care patients:

• T3 patients
• American Society of Anesthesiologists risk (ASA) 3
• Metastatic disease (Bone scan…)
• Previous prostate cancer therapy
• Distance between rectal mucosa and prostatic capsule of more than 8 mm thickness
• Prostate volume over 50cc
• Previous bladder cancer
• contraindication to MRI
• previous rectal or urinary fistulae

Inclusion Criteria for salvage patients:

• Age > 50 years
• T1 or T2
• Biochemical recurrence after radiotherapy (Phoenix definition: nadir+2ng/ml)
• 12 randomized biopsies
• Normal anal and rectal anatomy
• ASA 1 or 2

Exclusion Criteria for salvage patients:

• T3 patients
• ASA 3
• Metastatic disease (Bone scan…)
• Distance between rectal mucosa and prostatic capsule of more than 8 mm thickness
• Prostate volume over 50cc
• Previous bladder cancer
• contraindication to MRI
• previous rectal or urinary fistulae