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:
2026-03-26 @ 3:16 PM
Ignite Modification Date:
2026-03-26 @ 3:16 PM
NCT ID:
NCT07355504
Eligibility Criteria:
Inclusion Criteria:
* Men aged over 18 years
* Men with an estimated life expectancy of more than 10 years
* Biopsy-naïve men
* PSA level ≤ 20 ng/ml
* Presence, on the first multiparametric prostate MRI, of a PIRADS 3-5 lesion confirmed by local rereading if the MRI was performed outside the center
* MRI of sufficient quality (PI-QUAL score 2-3)
* PIRADS 3 lesion with a PSA density \<0.15 ng/ml/ml
* No signs of extracapsular extension or seminal vesicle invasion (MRI stage T2 confirmed by local rereading if MRI performed outside the center)
* No suspicious lymph node (confirmed by local rereading if MRI performed outside the center)
* Patient is insured (affiliated with the national health insurance system or benefiting from such coverage)
* Signed informed consent form
Exclusion Criteria:
* Men already under surveillance for a known MRI lesion (except if the previous MRI was performed less than 6 months ago)
* Known mutation in DNA repair genes or suggestive family history
* PIRADS 3 lesion with PSA density \< 0.15 ng/ml/ml
* PIRADS 5 lesion with suspected extracapsular extension or seminal vesicle invasion
* Suspicion of lymph node involvement
* Multiparametric prostate MRI showing a PIRADS 1-2 lesion
* Use of treatments that may modify the appearance of MRI lesions: 5-alpha reductase inhibitors, hormone therapy
* Patient with severe renal insufficiency (GFR \< 30 ml/min/1.73 m²)
* Contraindication to gadolinium injection
* Contraindication to prostate biopsy
* Vulnerable persons (covered by Articles L1111-6 to L1111-8 of the French Public Health Code)
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Study:
NCT07355504
Study Brief:
Protocol Section:
NCT07355504