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 @ 5:03 AM
Ignite Modification Date:
2025-12-25 @ 5:03 AM
NCT ID:
NCT03031418
Eligibility Criteria:
Inclusion Criteria:
* 50 years of age
* Clinical suspicion for prostate cancer
* Elevated Prostate-specific antigen between: 2.0 - 10 ng/ mL
* No clinical history of a prior negative biopsy
Exclusion Criteria:
* History of prior prostate biopsy.
* Use of medications or hormones that are known to affect serum Prostate-specific antigen levels within 3-6 months of study enrollment.
* Clinical symptoms of urinary tract infection (including prostatitis) at the time of enrollment.
* History of prostate cancer.
* History of invasive treatments for benign prostatic hypertrophy (Benign Prostatic Hyperplasia) or lower urinary track symptoms within 6 months of study enrollment.
* No known hepatitis (all types) and/or HIV documented in patient's medical record.
* Patients with history of concurrent renal/bladder tumors.
Healthy Volunteers:
True
Sex:
MALE
Minimum Age:
50 Years
Study:
NCT03031418
Study Brief:
Protocol Section:
NCT03031418