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 @ 3:37 AM
Ignite Modification Date:
2025-12-25 @ 3:37 AM
NCT ID:
NCT02594202
Eligibility Criteria:
* INCLUSION CRITERIA:
1. Adults (greater than or equal to 18 years of age) with biopsy-proven or suspected prostate cancer (elevated PSA abnormal digital rectal exam (DRE) abnormal prostate MRI, or family history) who require and are willing to undergo diagnostic or therapeutic intervention as part of their diagnosis, standard of care treatment, or follow-up/surveillance for their neoplasm.
2. ECOG performance status of 0-2
3. Must be willing and able to provide informed consent
4. PSA \> or equal to 1.0 ng/ml (for patients aged 30 - 49 years) OR
5. PSA \> or equal to 2.5 ng/ml (for patients 50 years or older) OR
6. Abnormal DRE (i.e. enlarged, asymmetric, nodular, firm or tender) OR
7. Abnormal prostate MRI finding OR
8. Family history of first degree relatives (brother or father) with prostate cancer or first-degree relatives (mother or sister) with breast or ovarian cancer
EXCLUSION CRITERIA:
1\. Subjects whose comorbidities would preclude diagnostic or therapeutic intervention.
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Study:
NCT02594202
Study Brief:
Protocol Section:
NCT02594202