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 @ 5:55 PM
Ignite Modification Date:
2025-12-24 @ 5:55 PM
NCT ID:
NCT04179968
Eligibility Criteria:
Inclusion Criteria:
* Patients with suspected prostate cancer (e.g., abnormal digital rectal exam, elevated and/or rising PSA) as determined by referring physician
* Patients must have had a diagnostic, standard of care mpMRI of the prostate with at least one lesion with a PI-RADS v2.1 score ≥ 4
* In men with PI-RADS v2.1 score 4, PSA should be ≥ 10 ng/mL. In men with at least one PI-RADS v2.1 score 5 lesion, there is no restriction on PSA level.
* Patients must be scheduled for biopsy or radical prostatectomy
* Patients should not have had any type of curative or palliative therapy for prostate cancer before enrolling in the study
* Patients must be medically stable as judged by the patient's physician
* Patients must be able to lie still for a total of 60 minutes for the PET/CT scans
* Ability to understand and the willingness to sign a written informed consent
Exclusion Criteria:
* Patients who have had a prior prostatectomy or radiotherapy for prostate cancer cannot participate in the study
* Patients who have had a prior biopsy for prostate cancer cannot participate in the study
* Patients who have been treated for cancers other than skin cancers
* Subjects may not be receiving any other investigational agents for the treatment of the cancer under study
* Patients may not weigh more than the maximum weight limit for the PET/CT scanner table (\>200 kilograms or 440 pounds)
* History of allergic reactions attributed to compounds of similar chemical or biologic composition to 68Ga PSMA-11 or other agents used in the study such as gadolinium-based intravenous contrast agent used during the mpMRI
* Prior transurethral resection of the prostate (TURP)/benign prostatic hyperplasia (BPH) procedures, including steam/laser therapies
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Study:
NCT04179968
Study Brief:
Protocol Section:
NCT04179968