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 @ 11:33 PM
Ignite Modification Date:
2025-12-24 @ 11:33 PM
NCT ID:
NCT04732156
Eligibility Criteria:
Inclusion Criteria:
* Men over 18 years of age
* Patient with clinical suspicion of prostate cancer referred for a multiparametric MRI of the prostate before a first series of biopsies or before new biopsies after one or more series of negative biopsies
* PSA ≤ 30 ng / ml
* Clinical stage ≤ T2c
* Affiliation or beneficiary of a social security scheme
Exclusion Criteria:
* Men over 80 years of age
* PSA\> 30 ng / ml
* Stage T3 or T4 on digital rectal examination
* Previous prostate biopsy performed within 12 months
* History of prostate cancer diagnosed by biopsy or endourethral resection.
* History of pelvic radiotherapy regardless of the cause.
* History of total or focal treatment for prostate cancer.
* History of hormone therapy
* MRI performed more than 3 months before biopsy
* Prostate MRI performed on a machine other than the center's machines accredited for the study.
* Presence of a hip prosthesis
* Contraindication to performing an MRI
* Contraindication to performing prostate biopsy
* Patient subject to a legal protection measure or deprived of liberty
* Subject participating or having participated in interventional medical research with an exclusion period still in progress
* Misunderstanding of the French language
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT04732156
Study Brief:
Protocol Section:
NCT04732156