Monitors prostate cancer that returned after treatment with a PET scan tracer
Tests 18F-DCFPyL PET scans to track prostate cancer in men whose disease came back.
Plain-language title generated from the registry record
Registry title: Prospective Monitoring of Subjects With Biochemically Recurrent Prostate Cancer Using 18FDCFPyL
Key facts
- Where
- Bethesda, United StatesSee the site
Where in United States
- National Institutes of Health Clinical CenterBethesda, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- National Cancer Institute (NCI)
- Trial code
- NCT05588128
- Record updated
- 10 November 2026
- Original description
Background:Read full original descriptionShow less
A Study of Prospective Monitoring of Subjects With Biochemically Recurrent Prostate Cancer Using 18F-DCFPyL
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.
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Exclusion: Androgen deprivation therapy (ADT) within the 6 months before the study intervention; Systemic therapy for prostate cancer within the 6 months before the study intervention. Other investigational agents, excluding those involving standard of care chemotherapy, received within 6 months prior to the study intervention are allowed; -Evidence of soft tissue disease on CT scan (or magnetic resonance imaging [MRI] as clinically indicated); NOTE: Lymph nodes <= 1.5 cm in the shortest dimension are allowed; Evidence of bone lesions on Tc99 bone scan; Prostatectomy within 1 year before the study intervention.
INCLUSION CRITERIA:; History of primary treatment for prostate cancer (either surgery or radiation); Serum PSA >= 0.50; Serum testosterone >100; Age >=18 years; Men must agree to use highly effective contraception (surgical sterilization) for 7 days after every study agent administration. Note: abstinence, defined as no heterosexual sexual intercourse when this is in line with the preferred and usual lifestyle of the subject is also acceptable; The ability of a participant to understand and the willingness to sign a written informed consent document.