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 @ 12:59 PM
Ignite Modification Date:
2025-12-24 @ 12:59 PM
NCT ID:
NCT01376661
Eligibility Criteria:
Inclusion Criteria:
* At least 18 years of age
* Histological documented adenocarcinoma of the prostate either newly diagnosed or previously diagnosed. Subjects who are diagnosed more than 3 months prior to time of enrollment in the active surveillance program must have biopsy repeated.
* PSA \< 10 ng/ml within 1 month of program enrollment
* Clinical stage less than or equal to T2a
* Biopsy sampling with at least 10-12 cores
* Gleason score less than or equal to 3 + 3
* No more than 2 cores involved
* No core more than 50% involved
* Eligible for definitive therapy
* Able to provide informed consent
* Able to complete a QOL questionnaire
* Able to comply with the scheduled follow-up appointments
Exclusion Criteria:
* See inclusion criteria for eligibility
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Maximum Age:
90 Years
Study:
NCT01376661
Study Brief:
Protocol Section:
NCT01376661