NCT05588128Recruiting
Prospective Monitoring of Subjects With Biochemically Recurrent Prostate Cancer Using 18FDCFPyL
A Study of Prospective Monitoring of Subjects With Biochemically Recurrent Prostate Cancer Using 18F-DCFPyL
Source: ClinicalTrials.gov · Last updated 16 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 350 (estimated)
- First submitted
- 18 Oct 2022
- Start date
- 21 Mar 2023
- Primary completion date
- 31 Dec 2026
- Lead sponsor
- National Cancer Institute (NCI)
- Diseases
- Prostate cancer
- NCT number
- NCT05588128
What you commit to
- Study type: Observational
- Planned participants: 350
- From 21 Mar 2023 to the primary completion date, 31 Dec 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other illness
- -Evidence of soft tissue disease on CT scan (or magnetic resonance imaging \[MRI\] as clinically indicated).
Other
- 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
Criteria the registry did not label
- 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
Age in the registry: 18 years to - · Sex: Male · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| National Institutes of Health Clinical Center Coordinator of this site? Confirm its status | Bethesda | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.