Status:
COMPLETED
Evaluation of HIFU in TREATMENT OF LOCALIZED PROSTATE CANCER and OF RECURRENCE AFTER RADIOTHERAPY
Lead Sponsor:
Association Francaise d'Urologie
Conditions:
Prostate Cancer
Ultrasound Therapy
Eligibility:
MALE
70+ years
Phase:
NA
Brief Summary
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 afte...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
March 23 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 24 2022
Estimated Enrollment :
3862 Patients enrolled
Trial Details
Trial ID
NCT04307056
Start Date
March 23 2015
End Date
August 24 2022
Last Update
January 12 2023
Active Locations (49)
Enter a location and click search to find clinical trials sorted by distance.
1
Centre Hospitalier d'Aix en Provence
Aix-en-Provence, France, 13616
2
Polyckinique du Beaujolais
Arnas, France, 69400
3
Clinique St Etienne
Bayonne, France, 64100
4
CHRU de Besançon
Besançon, France, 25000