Dynamic Focusing Evaluation for Prostate Cancer Treatment (FOC/DYN)
Cancer of Prostate
About this trial
This is an interventional treatment trial for Cancer of Prostate focused on measuring HIFU, Localized Prostate cancer, MRI, PSA nadir, Biopsy, High Intensity Focused Ultrasound, Prostate Specific Antigen (PSA)
Eligibility Criteria
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
Sites / Locations
- Edouard Herriot Hospital
Arms of the Study
Arm 1
Experimental
HIFU prostate treatment
The HIFU intervention will concern Primary care patients or Secondary care patients (salvage). Intervention with "Ablatherm Foc/Dyn" or "Focal One" HIFU treatment devices HIFU intervention will be administered with "Ablatherm Foc/Dyn or Focal One - First line" to Patients suffering from localized prostate cancer that has not been previously treated or Salvage HIFU intervention will be administered with "Ablatherm Foc/Dyn or Focal One - Post radiotherapy" to subjects harboring prostate cancer recurrency after radiotherapy