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

Association Francaise d'Urologie

Status

Completed

Conditions

Ultrasound Therapy

Prostate Cancer

Treatments

Procedure: High Intensity Focused Ultrasound (HIFU) Treatment

Procedure: Radical Prostatectomy

Study type

Interventional

Funder types

Other

Identifiers

2013-A01042-43 (Other Identifier)

HIFU/AFU/12.03

Details and patient eligibility

About

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

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

Enrollment

3,862 patients

Sex

Male

Ages

70+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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