18F-DCFPyL Imaging for Prostate Cancer
Trial Summary
What is the purpose of this trial?
Background: Identifying medium- and high-risk prostate cancer early may allow for treatments to work. But identification can be hard. Researchers want to see if a radiotracer used during PET scans can help. Objective: To test how an imaging agent called 18F-DCFPyL detects response to standard prostate cancer treatment. Eligibility: People ages 18 and older with newly diagnosed prostate cancer who have no evidence of distant metastatic disease and plan to get stereotactic body radiation therapy (SBRT) with or without androgen deprivation therapy (ADT). Design: Participants will be screened with: Medical history Physical exam Blood tests MRI Participants will have baseline MRI and PET/CT scans. For the MRI, they may get a contrast agent by IV injection. For the PET/CT scan, they will get an IV injection of 18FDCFPyL. About 1 to 2 hours later, they will get the PET/CT scan. During the scans, participants will lie on their back and remain still for 45 minutes to 1 hour. These scans will be repeated at different points during the study. Participants will get SBRT with or without ADT. Participants will complete questionnaires about their quality of life. Participants will be asked about any symptoms they are having. They will also be asked about medications they are using. They may have a physical exam. Participants will give blood and urine samples. They will give a tumor sample from a biopsy they have had in the past. After treatment, participants will have follow-up visits. These will occur 1 month after treatment, then every 3 months for a year, and then every 6 months for 1 more year.
Will I have to stop taking my current medications?
The trial protocol does not specify if you need to stop taking your current medications. However, you will be asked about the medications you are using, so it's best to discuss this with the trial team.
What data supports the effectiveness of the drug 18F-DCFPyL for prostate cancer?
Is 18F-DCFPyL safe for use in humans?
How does the drug 18F-DCFPyL differ from other prostate cancer treatments?
18F-DCFPyL is a unique imaging drug that targets the prostate-specific membrane antigen (PSMA) to help locate prostate cancer more accurately than conventional imaging methods. It has a high positivity rate, especially in patients with higher PSA levels, and can detect lesions that other scans might miss, leading to changes in patient management.34567
Research Team
Deborah Citrin, MD
Principal Investigator
National Cancer Institute (NCI)
Eligibility Criteria
This trial is for men aged 18+ with newly diagnosed localized prostate cancer, planning to undergo SBRT possibly with ADT. They must have an ECOG status of <=2, use contraception if applicable, and can't have prior prostate cancer treatments. HIV-positive participants are eligible if virally suppressed.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Baseline Imaging
Participants will have baseline MRI and PET/CT scans with 18F-DCFPyL
Treatment
Participants receive SBRT with or without ADT
Post-Treatment Imaging
Participants undergo 18F-DCFPyL PET/CT and mpMRI 6 months following completion of SBRT
Follow-up
Participants are monitored for safety and effectiveness after treatment, with follow-up visits 1 month after treatment, then every 3 months for a year, and then every 6 months for 1 more year
Treatment Details
Interventions
- 18F-DCFPyL
Find a Clinic Near You
Who Is Running the Clinical Trial?
National Cancer Institute (NCI)
Lead Sponsor