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 @ 3:17 PM
Ignite Modification Date:
2025-12-24 @ 3:17 PM
NCT ID:
NCT04266392
Eligibility Criteria:
Inclusion Criteria:
* subject has prostate cancer treated with surgery, radiation therapy and/or chemotherapy for localized disease
* subject has biochemical recurrence defined in postsurgical patients as a PSA value = \> 0.2 ng/mL followed by a subsequent confirmatory PSA value = \>0.2 ng/mL according to the American Urological Association (AUA) guidelines, or three consecutive rises above the nadir in patients following radiation therapy according to the American Society for Radiation Therapy and Oncology (ASTRO).
* in most cases, it will be required that the patient has had a prior CIM scan (such as a BS, MRI, CT or PET with F-18 Fluciclovine) performed before enrollment in this study; the only exception would be if the PSA level of the patient is remarkably high indicating apparent recurrence.
Exclusion Criteria:
* less than 18 years of age (prostate cancer is not prevalent in the pediatric population);
* any contraindications to MRI imaging such as electrical implants, cardiac pacemakers or perfusion pumps;
* ferromagnetic implants such as aneurysm clips, surgical clips, prostheses, artificial hearts, valves with steel parts, metal fragments, shrapnel, tattoos near the eye, or ferromagnetic objects such as jewelry or metal clips in clothing;
* is unable to lie comfortably on a bed inside the scanner for 60 minutes as assessed by physical examination and medical history (e.g. back pain, arthritis);
* if they have had treatment with investigational drug within 30 days prior to trial enrollment;
* if they had administration of another radioisotope within five physical half-lives of trial enrollment;
* if they had radiation or chemotherapy within 4 weeks prior to trial enrollment;
Eligibility will be determined by a screening interview. All subjects recruited for the study will be able to withdraw from the study at any time.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04266392
Study Brief:
Protocol Section:
NCT04266392