NCT03173924Active, not recruitingPhase 2
18F-DCFPyL PSMA- Versus 18F-NaF-PET Imaging for Detection of Metastatic Prostate Cancer
Evaluation of 18F-DCFPyL PSMA- Versus 18F-NaF-PET Imaging for Detection of Metastatic Prostate Cancer
Source: ClinicalTrials.gov · Last updated 3 Nov 2026
Brief summary (registry, in English)
Background: Prostate cancer is the second leading cause of cancer deaths in American men. Few options exist to create images of this type of cancer. Researchers think an experimental radiotracer called 18F-DCFPyL could find sites of cancer in the body. Objective: To see if 18F-DCFPyL can identify sites of prostate cancer in people with the disease. Eligibility: People ages 18 and older who have metastatic prostate cancer Design: Participants will be screened with: * Blood tests * Physical exam * Medical history Participants will be assigned to 1 of 2 groups based on their PSA. Participants will have 18F-DCFPyL injected into a vein. About 2 hours later they will have a whole-body Positron Emission Tomography/Computed Tomography (PET/CT). For the scan, they will lie on their back on the scanner table while it takes pictures of the body. This lasts about 50 minutes. On another day, participants will have 18F -NaF injected into a vein. About 1 hour later, they will have a whole-body PET/CT. Participants will be contacted 1 3 days later for follow-up. They may undergo PET/Magnetic Resonance Imaging (MRI) either after having a 18F-DCFPyL PET/CT, or in place of PET/CT imaging. A tube may be placed in the rectum. More coils may be wrapped around the outside of the pelvis. If the 18F-DCFPyL PET/CT is positive participants will be encouraged to undergo a biopsy of one of the tumors. The biopsy will be taken through a needle put through the skin into the tumor. Participants will be followed for 1 year. During this time researchers will collect information about their prostate cancer, such as PSA levels and biopsy results. About 4-6 months after scanning is completed, participants may have a tumor biopsy. The biopsy will be taken through a needle put through the skin into the tumor. ...
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 98 (actual)
- First submitted
- 31 May 2017
- Start date
- 6 Jun 2017
- Primary completion date
- 6 Feb 2028
- Lead sponsor
- National Cancer Institute (NCI)
- Diseases
- Prostate cancer
- NCT number
- NCT03173924
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 98
- From 6 Jun 2017 to the primary completion date, 6 Feb 2028
- 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
- Subjects for whom participating would significantly delay the scheduled standard of care therapy.
Other illness
- Subjects with any coexisting medical or psychiatric condition that is likely to interfere with study procedures and/or results.
- Other medical conditions deemed by the principal investigator (or associates) to make the subject unsafe/ineligible for protocol procedures.
Lab values
- Serum creatinine greater than 2 times the upper limit of normal
Other
- Subjects with severe claustrophobia unresponsive to oral anxiolytics
- Subjects weighing greater than 350 lbs. (weight limit for scanner table), or unable to fit within the imaging gantry
Criteria the registry did not label
- 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.
- Patients must have confirmation of prostate cancer with identifiable metastatic disease on at least 1 clinically indicated imaging modality. If there is only soft tissue metastasis, one lesion must measure at least 6 mm or greater. OR Documented history of metastatic prostate cancer.
- Patients must be co-enrolled on a UOB, GMB or ROB protocol
- Histological confirmation of prostate cancer
- Patients must be willing to undergo mandatory research biopsy
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 | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.