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
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 180
- Locations
- 2
- Primary Endpoint
- Necrosis measurement (immediate efficacy)
Study Overview
Brief Summary
Define the best acoustic parameters for the dynamic focusing HIFU transducer in the treatment of localized Prostate Cancer.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 70 Years to — (Older Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •for primary care patients:
- •Age > 70 years
- •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
- •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
- •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
Arms & Interventions
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
Intervention: "Ablatherm Foc/Dyn" or "Focal One" HIFU treatment (Device)
Outcomes
Primary Outcomes
Necrosis measurement (immediate efficacy)
Time Frame: Day 7
The coagulation necrosis induced by the HIFU dynamic focusing treatment of the prostate is evaluated by MRI in the first week post treatment.
Secondary Outcomes
- Adverse events reporting rates (safety and the morbidity) at 6 months(6 months)
- Histological marker measurement (mid term efficacy)(6 months)
- Biochemical marker measurement (mid term efficacy)(6 months)
- Rectal wall preservation (immediate safety and morbidity)(Day 7)
- Adverse events reporting rates (safety and the morbidity) at 24 months(24 months)
- Quality of life score(6 months)
- IPSS score(6 months)
- IIEF-5 score(6 months)