Evaluation of HIFU in TREATMENT OF LOCALIZED PROSTATE CANCER and OF RECURRENCE AFTER RADIOTHERAPY

EVALUATION OF HIGH INTENSITY FOCUSED ULTRASOUND (HIFU) IN CURATIVE TREATMENT OF LOCALIZED PROSTATE CANCER AT LOW OR INTERMEDIATE RISK AND IN TREATMENT OF RECURRENCE AFTER RADIOTHERAPY (FORFAIT INNOVATION ART L165-1-1 Social Security Code)

to compare the efficacy of HIFU treatment with standard treatment in two situations:

1. as first-line cancer treatment, HIFU is compared to radical prostatectomy.
2. for patients with recurrence after external beam radiotherapy, HIFU treatment is compared to radical prostatectomy.

General inclusion criteria

• Patients with localized adenocarcinoma of the prostate classified as T1-2, N0, Nx M0
• classified as low or intermediate risk
• Patient with PSA < 15 ng/ml, Gleason score ≤ 7 restricted to the form [3 + 4].
• Biopsy with at least 12 specimens and a maximum of four out of six invaded sextants
• Patient with a pelvic MRI if there is an intermediate risk and a bone scintigraphy if PSA > 10 ng/ml
• Patient affiliated with health insurance or beneficiary of an equivalent plan

Inclusion criteria for the HIFU Arm

• Patients 70 years of age or older
• Patients with a life expectancy related to age and associated illness estimated to be greater than 5 years

Inclusion Criteria for Total Prostatectomy Arm

• Patients with a life expectancy greater than 10 years and a state of health allowing general anaesthesia.

NON-INCLUSION CRITERIA

• Patient participating in other biomedical research within 3 months prior to their inclusion in this protocol
• Included patient simultaneously participating in another research study