18F-DCFPyL PET/CT in High Risk and Recurrent Prostate Cancer
Status:
Recruiting
Trial end date:
2025-10-01
Target enrollment:
Participant gender:
Summary
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 screened with medical history and physical exam. They will have blood
taken.
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.