Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:34 PM
Ignite Modification Date:
2025-12-24 @ 11:34 PM
NCT ID:
NCT04307056
Eligibility 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
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
70 Years
Study:
NCT04307056
Study Brief:
Protocol Section:
NCT04307056