Trial Summary
What is the purpose of this trial?Background:
Prostate cancer is the second leading cause of cancer deaths in American men. When prostate cancer is confined to the prostate there is a high chance of cure. However, it is outside the prostate or comes back after treatment, additional therapy may be needed. Current methods of imaging prostate cancer are limited. Researchers want to see if a radiotracer called 18F-DCFPyL can identify prostate cancer in patients who have a high risk of cancer spreading outside the prostate or who have signs of recurrent cancer after treatment.
Objectives:
To see if the radiotracer 18F-DCFyL can help identify prostate cancer in the body before or after therapy.
Eligibility:
Men ages 18 and older who have prostate cancer that has been newly diagnosed, or has relapsed after radiation or surgery
Design:
Participants will be divided into 2 groups.
* Group 1 will be men with cancer that has been newly diagnosed as high risk by their doctor who are scheduled to have prostate removal surgery or undergo biopsy before radiation therapy.
* Group 2 will be men who have presumed prostate cancer relapse after prostate removal surgery or radiation therapy.
Both groups will have scans taken. Participants will lie still on a table in a machine that takes pictures of their body. 18F-DCFyL will be injected by intravenous (IV) line.
Participants will be contacted for follow-up after scans.
Participants in Group 1 may have surgery to remove their prostate gland or a biopsy to remove some prostate tissue. This procedure will be standard of care and is not a part of this study. They will also have an extra MRI scan of their prostate. For this, a tube, called an endorectal coil, will be placed in their rectum. Other tubes may be wrapped around the inside of their pelvis. A contrast agent will be given by IV.
Participants in Group 2 may also undergo an MRI of the pelvis and may have a biopsy of abnormalities found on the 18F-DCFyL scan.
Participants will have data about their prostate cancer collected for up to 1 year.
Eligibility Criteria
Men 18+ with prostate cancer either newly diagnosed as high risk or showing signs of recurrence after treatment. They must be able to consent, agree to use contraception, and fit within the scanner's weight limit. Exclusions include severe claustrophobia, conditions that could affect results, excessive serum creatinine levels, or if participation delays standard care.Inclusion Criteria
I agree to use effective birth control during and for 2 months after the study.
I can take care of myself and am up and about more than half of my waking hours.
My prostate cancer was confirmed through a tissue examination.
+5 more
Exclusion Criteria
Serum creatinine greater than 2 times the upper limit of normal
Subjects with any coexisting medical or psychiatric condition that is likely to interfere with study procedures and/or results
I have severe claustrophobia that doesn't improve with anxiety medication.
+3 more
Participant Groups
The trial is testing a radiotracer called 18F-DCFPyL for detecting prostate cancer in high-risk or recurrent cases. Participants will undergo scans using this tracer and may have additional MRI scans and biopsies. The study aims to improve imaging techniques for better diagnosis and management of prostate cancer.
2Treatment groups
Experimental Treatment
Group I: 2/biochemical recurrence (bcr)Experimental Treatment3 Interventions
18F-DCFPyL PET/CT imaging, unlabeled PSMA-11 (optional)
Group II: 1/Localized High RiskExperimental Treatment2 Interventions
18F-DCFPyL PET/CT imaging, unlabeled PSMA-11 (optional) and possible prostatectomy
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
National Institutes of Health Clinical CenterBethesda, MD
Loading ...
Who Is Running the Clinical Trial?
National Cancer Institute (NCI)Lead Sponsor