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 @ 11:37 PM
Ignite Modification Date:
2025-12-24 @ 11:37 PM
NCT ID:
NCT03234556
Eligibility Criteria:
Inclusion Criteria:
* Written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization for release of personal health information
* Note: HIPAA authorization may be included in the informed consent or obtained separately
* Eastern Cooperative Oncology Group (ECOG) performance status of =\< 1 within 3 months (93 days) prior to being registered for protocol
* African-American or white men (Hispanic or non-Hispanic)
* Prostate biopsy-naive or a single negative biopsy
* Having elevated prostate specific antigen (PSA) (\> 2.5 ng/ml) and no palpable nodule on digital rectal exam (DRE)
* Ability to understand the willingness to sign a written informed consent
* Patients must be willing to undergo a radiologic imaging before and after biopsy of the prostate
* Patients must be willing to undergo a biopsy of the prostate
Exclusion Criteria:
* Patients who have had chemotherapy or radiotherapy within 12 months of the study for other diagnoses not related to prostate cancer
* Patients receiving any other investigational agents
* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
* Patients with active inflammatory bowel disease
* Patients who are unable to undergo MRI
* Patients who had any surgery of the prostate including TURP (transurethral resection of the prostate)
* Patients who had \> 1 prior prostate biopsy
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
40 Years
Study:
NCT03234556
Study Brief:
Protocol Section:
NCT03234556