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 @ 12:31 AM
Ignite Modification Date:
2025-12-25 @ 12:31 AM
NCT ID:
NCT03181867
Eligibility Criteria:
* INCLUSION CRITERIA:
* Age greater than or equal to 18 years old.
* Eastern Cooperative Oncology Group (ECOG) Performance score of 0 to 2.
* Ability of subject to understand and the willingness to sign a written informed consent document.
* Histologically confirmed adenocarcinoma of the prostate.
* Patients (including those receiving androgen deprivation therapy) fit criteria for one of the following categories:
* Cohort 1 known localized high risk prostate cancer (PSA \>10, Gleason 8-10 or clinical stage \>T2c) with evidence of disease on standard imaging, OR
* Cohort 2 nonspecific or no evidence of disease on standard imaging modality AND biochemical prostate cancer relapse with a PSA greater than or equal to 0.2 ng/mL. Patients must be willing to undergo mandatory research biopsy
* Participants must be co-enrolled on a MIB, UOB, GMB or ROB protocol.
* The effects of 18F-DCFPyL on the developing human fetus are unknown. For this reason, individuals must agree to use adequate contraception with their partner (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation and 2 months after 18F-DCFPyL scan. Should a partner become pregnant or suspect she is pregnant while her partner is participating in this study, she should inform the treating physician immediately.
EXCLUSION CRITERIA:
* Subjects for whom participating would significantly delay the scheduled standard of care therapy.
* Subjects with any coexisting medical or psychiatric condition that is likely to interfere with study procedures and/or results.
* Subjects with severe claustrophobia unresponsive to oral anxiolytics
* Other medical conditions deemed by the principal investigator (or associates) to make the subject unsafe/ineligible for protocol procedures.
* Subjects weighing greater than 350 lbs. (weight limit for scanner table), or unable to fit within the imaging gantry.
* Serum creatinine greater than 2 times the upper limit of normal.
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Study:
NCT03181867
Study Brief:
Protocol Section:
NCT03181867