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 @ 2:06 AM
Ignite Modification Date:
2025-12-25 @ 2:06 AM
NCT ID:
NCT02138760
Eligibility Criteria:
Inclusion Criteria:
* PSA \> 2.5 ng/ml (ages 30-50) or PSA \> 4.0 ages (50-79)
* Patients with prior negative prostate biopsy
* Written informed consent
* Age \> 30
Exclusion Criteria:
* Prior diagnosis of prostate cancer
* Age\> 79
* No contraindication to MRI or prostate biopsy (e.g. coagulopathy, severe medical comorbidity prohibiting halting of anticoagulation therapies, anatomical contraindications)
* Active urinary tract infection or indwelling catheter
* Prior pelvic irradiation
* Prior androgen deprivation hormonal therapy
* Prostate surgery (e.g. prostate biopsy, transurethral prostate procedure) within 8 weeks prior to mpMRI.
* Contraindication to MRI (extreme claustrophobia, metallic implants incompatible with MRI)
Healthy Volunteers:
True
Sex:
MALE
Minimum Age:
30 Years
Maximum Age:
79 Years
Study:
NCT02138760
Study Brief:
Protocol Section:
NCT02138760