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 @ 3:31 AM
Ignite Modification Date:
2025-12-25 @ 3:31 AM
NCT ID:
NCT05180305
Eligibility Criteria:
Inclusion Criteria:
* Men of screening age (≧45) who are scheduled for prostate needle biopsy due to suspicion of prostate cancer and have a total PSA \< 10ng/ml within the previous 3 months.
* Extended Sextant biopsy pattern that must include a minimum of 12 cores. MRI targeted biopsy preferred where available.
* Age, total PSA, biopsy pathology, prostate medication history, and ethnicity data must be available;
* The index biopsy must occur following and within 16 weeks of blood draw.
Exclusion Criteria:
* Subject does not undergo their prostate biopsy within 16 weeks of collection of pre-biopsy blood sample;
* Previous diagnosis of prostate cancer;
* Prostate biopsy within the previous 3 months;
* Men with a total PSA\>10ng/ml within the previous 3 months;
* Provides less than the required amount of blood;
* Considered incompetent to provide informed consent;
* Does not understand and read language of informed consent;
* Age, total PSA, biopsy pathology information, medication history or ethnicity data unavailable;
* Males who are not of screening age (\<45);
* Subjects whose classification as cancer positive or negative is undetermined following biopsy due to suspicious results such as Atypical Suspicious Acinar Proliferation (ASAP);
* Blood collected after index biopsy.
* Subject is taking antibiotics at the time of blood collection or has taken antibiotics within the 2 weeks prior to blood collection.
Sex:
MALE
Minimum Age:
45 Years
Study:
NCT05180305
Study Brief:
Protocol Section:
NCT05180305