Dynamic Focusing Evaluation for Prostate Cancer Treatment (FOC/DYN)

EDAP TMS

Status: Unknown

Conditions: Cancer of Prostate

Treatments: Device: "Ablatherm Foc/Dyn" or "Focal One" HIFU treatment

Study type: Interventional

Funder types: Industry

Identifiers

NCT03632980

2011-A00313-38 (Other Identifier)

HIFU/F/10.08

Details and patient eligibility

About

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

Enrollment: 180 patients

Sex: Male

Ages: 70+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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180 participants in 1 patient group

HIFU prostate treatment

Experimental group

Description:

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

Treatment:

Device: "Ablatherm Foc/Dyn" or "Focal One" HIFU treatment