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 @ 7:49 PM
Ignite Modification Date:
2025-12-24 @ 7:49 PM
NCT ID:
NCT05872503
Eligibility Criteria:
* INCLUSION CRITERIA:
* Age \>35 years.
* Men self-identified as being of African Ancestry.
* Elevated serum prostate specific antigen of \>=3ng/ml and/or positive digital rectal examination and/or strong family history of prostate cancer (at least 1 first or second degree male relative).
* ECOG performance status \<=2.
* Ability of participant to understand and the willingness to sign a written informed consent document.
* Must be co-enrolled in protocols 16-C-0010 and/or 18-C-0017.
EXCLUSION CRITERIA:
* Prior prostate biopsy.
* Prior radiotherapy or surgery for prostate cancer.
* Prior or ongoing hormonal therapy or chemotherapy (e.g., docetaxel) for prostate cancer.
* Participants unwilling or unable to undergo MRI, including participants with contraindications to MRI.
* Participants unwilling or unable to undergo biopsy, including participants with contraindications to biopsy.
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
35 Years
Maximum Age:
120 Years
Study:
NCT05872503
Study Brief:
Protocol Section:
NCT05872503