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 @ 5:11 AM
Ignite Modification Date:
2025-12-25 @ 5:11 AM
NCT ID:
NCT04240327
Eligibility Criteria:
Inclusion Criteria:
1. Male participant, aged 40-85 years.
2. In good general health as evidenced by medical history.
3. Referred for a biopsy of the prostate for evaluation of prostate cancer due to elevated or increasing prostate-specific antigen (PSA) or an abnormal digital rectal exam (DRE).
4. Participant must agree to forego testosterone supplementation during the duration of the study due to unknown impacts on prostate cancer biomarkers.
Exclusion Criteria:
1. Previous or current history of prostate cancer or treatment for prostate cancer.
2. Previous history of pelvic radiation.
3. Known allergic reactions to MRI contrast or inability to undergo MRI due to renal toxicity.
4. Inability to undergo blood draw or biopsy of the prostate as per protocol.
5. Prior MRI guided biopsy of the prostate for prostate cancer evaluation.
6. Previous prostate biopsy or prostate procedure within 6 months of enrollment within the trial.
7. Standard contraindications to MRI, such as allergies to contrast die, renal toxicity, ferromagnetic metal in body/eye, pacemaker, defibrillator, other mechanical device, or extreme claustrophobia (medication with anti-anxiety agents, such as Ativan, may be attempted) will prevent eligibility and will be applied for all protocol-related MRIs.
8. Patients with impaired decision-making capacity.
Healthy Volunteers:
True
Sex:
MALE
Minimum Age:
40 Years
Maximum Age:
85 Years
Study:
NCT04240327
Study Brief:
Protocol Section:
NCT04240327