Actively Recruiting
Prospective Monitoring of Subjects With Biochemically Recurrent Prostate Cancer Using 18FDCFPyL
Led by National Cancer Institute (NCI) · Updated on 2026-05-07
350
Participants Needed
1
Research Sites
249 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Background: Prostate cancer is the second leading cause of cancer-related death in American men. The disease recurs in up to 50,000 men each year after their early-stage disease was treated; however, at this stage, imaging scans are often unable to find the disease in the body. In this natural history study, researchers want to find out if a new radiotracer (18F-DCFPyL) injected before positron emission tomography (PET) imaging can help identify sites in the body with cancer. Objective: To learn more about how 18F-DCFPyL PET/CT scans detect change over time in men with recurrent prostate cancer. Eligibility: Men aged 18 and older with prostate cancer that returned after treatment. Design: Participants will be screened with blood tests. They will also have a bone scan and a computed tomography (CT) scans of the chest, abdomen, and pelvis. Participants will have an initial study visit. They will have a physical exam and blood tests. They will have a PET/CT scan with 18F-DCFPyL. The radiotracer will be injected into a vein; this will take about 20 seconds. The PET/CT scan will be done 1 to 2 hours later. Participants will lie still on a scanner table while a machine captures images of their body. The scan will take 45 minutes. Participants will return for blood tests every 3 months. Participants will return for additional scans with 18F-DCFPyL on this schedule: Once a year if their previous scan was negative for prostate cancer. Every 6 months if their previous scan was positive for prostate cancer. Participants may be in the study up to 5 years.
CONDITIONS
Official Title
Prospective Monitoring of Subjects With Biochemically Recurrent Prostate Cancer Using 18FDCFPyL
Who Can Participate
Eligibility Criteria
You may qualify if you...
- History of primary treatment for prostate cancer with surgery or radiation
- Serum PSA level of 0.50 or higher
- Serum testosterone level greater than 100
- Men aged 18 years or older
- Agreement to use highly effective contraception or abstinence for 7 days after each study agent administration
- Ability to understand and sign informed consent
You will not qualify if you...
- Evidence of soft tissue disease on CT or MRI scans, except lymph nodes 1.5 cm or smaller
- Evidence of bone lesions on Tc99 bone scan
- Prostatectomy within 1 year before the study intervention
- Androgen deprivation therapy within 6 months before the study intervention
- Systemic therapy for prostate cancer within 6 months before the study intervention
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
National Institutes of Health Clinical Center
Bethesda, Maryland, United States, 20892
Actively Recruiting
Research Team
A
Amy R Hankin, P.A.-C
CONTACT
M
Melissa L Abel, M.D.
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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