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 @ 12:15 AM
Ignite Modification Date:
2025-12-25 @ 12:15 AM
NCT ID:
NCT01337258
Eligibility Criteria:
Inclusion Criteria:
* Men aged 50 to 75 years
* serum prostate-specific antigen (PSA) ≥2.5 ng per milliliter and ≤10 ng per milliliter (men aged 50-60 years) or ≥3.0 ng per milliliter and ≤10 ng per milliliter (men aged \>60 years)
* single, negative prostate biopsy (6-12 cores) within 6 months prior to enrollment (independent of the study)
Exclusion Criteria:
* Principal exclusion criteria were more than one prior prostate biopsy
* high-grade intraepithelial neoplasia (HG-PIN) or atypical small acinar proliferation (ASAP) on the pre-entry prostate biopsy
* a prostate volume \>80 ml, previous prostate surgery
* International Prostate Symptom Score (IPSS) ≥25 or ≥20 if already on alpha-blocker therapy for BPH
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
50 Years
Maximum Age:
75 Years
Study:
NCT01337258
Study Brief:
Protocol Section:
NCT01337258