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 @ 7:10 PM
Ignite Modification Date:
2025-12-24 @ 7:10 PM
NCT ID:
NCT04867603
Eligibility Criteria:
Inclusion Criteria:
* Patients who have a clinical suspicion of prostate cancer defined by PI-RADS 3, 4 or 5 lesions detected on MRI as well as patients with negative prostate MRI or those with PI-RADS 1 or 2 lesions if they have continued suspicion for prostate cancer. Patients who cannot undergo MRI imaging but have a clinical suspicion for prostate cancer based on serum PSA level, family history or clinical examination (positive digital rectal examination) can also be included.
* Able to tolerate PET/CT scans
* Informed consent must be given and signed
Exclusion Criteria:
* Anti-cancer treatment (chemotherapy and/or radiation therapy) within the last 2 weeks
* Known allergy against Ga-68 PSMA
* Prior prostate biopsy within the last 2 weeks
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Study:
NCT04867603
Study Brief:
Protocol Section:
NCT04867603