18F-DCFPyL PET/CT in High Risk and Recurrent Prostate Cancer

• Status: Recruiting
• Trial end date: 2025-10-01
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Cancer Institute (NCI)
• Treatments: Fluorodeoxyglucose F18

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 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

• The effects of 18F-DCFPyL on the developing human fetus are unknown. For this reason, men 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

• Subjects receiving androgen deprivation therapy (ADT)

• Serum creatinine greater than 2 times the upper limit of normal