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 @ 4:04 AM
Ignite Modification Date:
2025-12-25 @ 4:04 AM
NCT ID:
NCT04825002
Eligibility Criteria:
Inclusion Criteria:
1. Men undergoing a first-time prostate biopsy to rule out cancer
2. Serum PSA ≥3ng/mL, ≤20ng/mL
3. Age≥50 years, ≤80 years
4. Clinical stage ≤T2c
5. Patients must be able to provide written informed consent.
Exclusion Criteria:
1. Patients has any prior needle biopsy of the prostate
2. Patients has a prior history of prostate cancer
3. Patients has a prior history of pelvic radiation therapy or androgen deprivation therapy
4. Patients has a prior history of BPH operation
5. Patient with uncorrectable coagulopathies
6. Unable to tolerate a TRUS guided biopsy.
7. Patients had 5-alpha reductase inhibitor in the past six months.
8. The patient has had a urinary tract infection or acute prostatitis in the last three months.
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
50 Years
Maximum Age:
80 Years
Study:
NCT04825002
Study Brief:
Protocol Section:
NCT04825002