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 @ 4:16 PM
Ignite Modification Date:
2025-12-24 @ 4:16 PM
NCT ID:
NCT04843566
Eligibility Criteria:
Inclusion Criteria
* Male sex
* Age ≥18 years
* Men without previous prostate biopsy (first time prostate biopsy)
* Willingness to sign informed consent and adhere to the study protocol
Exclusion Criteria
* Acute prostatitis within the last 6 months
* PSA \> 20 ng/mL in men who have previously undergone prostate biopsy
* Current non-urologic bacterial infection requiring active treatment with antibiotics
* Unfit to undergo prostate biopsy under local anesthesia
* Prior definitive therapy for prostate cancer, such as radiation therapy or partial gland ablation
* Men who have previously undergone prostate biopsy in whom artifact would reduce quality of prostate MRI (extensive orthopedic pelvic metal)
* Contraindication to prostate MRI (claustrophobia, pacemaker, chronic kidney disease) in men who have previously undergone prostate biopsy
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Study:
NCT04843566
Study Brief:
Protocol Section:
NCT04843566