18F-DCFPyL PSMA- Versus 18F-NaF-PET Imaging for Detection of Metastatic Prostate Cancer
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|ClinicalTrials.gov Identifier: NCT03173924|
Recruitment Status : Recruiting
First Posted : June 2, 2017
Last Update Posted : September 5, 2021
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.
To see if 18F-DCFPyL can identify sites of prostate cancer in people with the disease.
People ages 18 and older who have metastatic prostate cancer
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.
|Condition or disease||Intervention/treatment||Phase|
|Metastatic Prostate Cancer Prostatic Neoplasms Prostate Cancer Prostatic Cancer Prostate Neoplasms||Drug: 18F-NaF Drug: 18F-DCFPyL Drug: 18F-FDG||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||180 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Evaluation of 18F-DCFPyL PSMA- Versus 18F-NaF-PET Imaging for Detection of Metastatic Prostate Cancer|
|Actual Study Start Date :||June 6, 2017|
|Estimated Primary Completion Date :||December 30, 2022|
|Estimated Study Completion Date :||June 30, 2025|
Experimental: 1/Experimental intervention
18F-DCFPyL is administered to cohorts
Baseline IV followed by PET/CT IMAGING
Baseline IV followed by PET/CT IMAGING. Additional 18F-DCFPyL PET/CTs might be performed during the subject s follow up period if, in the opinion of the referring clinician, there has been a considerable change in patient status (progression or response) based on clinical grounds/PSA value or to help assess changes of standard of care therapy.
Baseline IV followed by PET/CT IMAGING. Additional 18F-FDG PET/CTs may be obtained per PI discretion within a 21-day window relative to each 18F-DCFPyL PET/CTs.
- Accuracy of DCFPyL-PET/CT diagnostics [ Time Frame: 36 months ]Accuracy of DCFPyL-PET/CT diagnostics
- PSMA expression in lesion samples from patients with presumed stable disease and actively expanding disease [ Time Frame: 36 months ]Correlation between PSMA expression and PSA levels
- Association between PSA parameters and the number of metastases identified with DCFPyL- PET/CT (or PET/MRI imaging if available). [ Time Frame: 36 months ]Correlation between PSA parameters and the number of metastases identified with DCFPyL- PET/CT
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03173924
|Contact: Yolanda McKinney, R.N.||(240) firstname.lastname@example.org|
|United States, Maryland|
|National Institutes of Health Clinical Center||Recruiting|
|Bethesda, Maryland, United States, 20892|
|Contact: For more information at the NIH Clinical Center contact National Cancer Institute Referral Office 888-624-1937|
|Principal Investigator:||Peter L Choyke, M.D.||National Cancer Institute (NCI)|