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 @ 3:01 PM
Ignite Modification Date:
2025-12-24 @ 3:01 PM
NCT ID:
NCT01024959
Eligibility Criteria:
Inclusion Criteria:
* Men 40+ years of age who have had at least 1 previous negative prostate biopsy, who have never had a positive prostate biopsy, and who have been recommended for a repeat biopsy by their clinician.
* The subject must be able to comprehend and sign an approved informed consent form and other applicable study enrollment documents
Exclusion Criteria:
* Use of medications or hormones that are known to affect serum PSA 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 (BPH) or lower urinary tract symptoms within 6 months of study enrollment
* Medical history or concurrent illness that the investigator considers sufficiently serious to interfere with the conduct, completion, or results of this trial, or constitutes an unacceptable risk to the subject
* Participation in pharmaceutical or treatment related clinical study within 6 months of study enrollment. Exception: Trials for non-prostate conditions may be acceptable, with approval by the investigator and Sponsor
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
40 Years
Study:
NCT01024959
Study Brief:
Protocol Section:
NCT01024959