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:
2025-12-25 @ 1:26 AM
Ignite Modification Date:
2025-12-25 @ 1:26 AM
NCT ID:
NCT03749993
Eligibility Criteria:
Inclusion Criteria:
* well-informed men with the wish for prostate cancer screening
* prostate biopsy naïve
* life expectancy \> 10 years
* men \> 50 years of age
* men \> 45 years of age with a family history of prostate cancer
* African-Americans \> 45 years of age
Exclusion Criteria:
* prostate biopsy performed prior to study
* life expectancy \< 10 years
* acute urinary tract infection
* NIH-CPSI score 19 (leads to initiation of urologic diagnostics and treatment)
* IPSS score 20 (leads to initiation of urologic diagnostics and treatment)
Contraindications for MRI:
* Heart pacemaker
* Artificial heart valves (some types are eligible)
* Cochlea implant
* ICD
* Metallic foreign bodies/devices/implants (neuro-stimulator, pain or insulin pump, etc.)
* Severe claustrophobia
Healthy Volunteers:
True
Sex:
MALE
Minimum Age:
46 Years
Maximum Age:
75 Years
Study:
NCT03749993
Study Brief:
Protocol Section:
NCT03749993