18F-DCFPyL PSMA- Versus 18F-NaF-PET Imaging for Detection of Metastatic Prostate Cancer
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|ClinicalTrials.gov Identifier: NCT03173924|
Recruitment Status : Enrolling by invitation
First Posted : June 2, 2017
Last Update Posted : May 30, 2023
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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 31, 2023|
|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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||Male|
|Accepts Healthy Volunteers:||No|
- 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
- Subjects for whom participating would significantly delay the scheduled standard of care therapy.
- Subjects with any coexisting medical or psychiatric condition that is likely to interfere with study procedures and/or results.
- Subjects with severe claustrophobia unresponsive to oral anxiolytics
- Other medical conditions deemed by the principal investigator (or associates) to make the subject unsafe/ineligible for protocol procedures.
- Subjects weighing greater than 350 lbs. (weight limit for scanner table), or unable to fit within the imaging gantry
- Serum creatinine greater than 2 times the upper limit of normal
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
|United States, Maryland|
|National Institutes of Health Clinical Center|
|Bethesda, Maryland, United States, 20892|
|Principal Investigator:||Peter L Choyke, M.D.||National Cancer Institute (NCI)|
|Responsible Party:||National Cancer Institute (NCI)|
|Other Study ID Numbers:||
|First Posted:||June 2, 2017 Key Record Dates|
|Last Update Posted:||May 30, 2023|
|Last Verified:||May 25, 2023|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||Yes|
|Plan Description:||.All IPD recorded in the medical record will be shared with intramural investigators upon request. In addition, all large scale genomic sequencing data will be shared with subscribers to dbGaP.|
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
|Time Frame:||Clinical data available during the study and indefinitely.@@@@@@Genomic data are available once genomic data are uploaded per protocol GDS plan for as long as database is active.|
|Access Criteria:||Clinical data will be made available via subscription to BTRIS and with the permission of the study PI. @@@@@@Genomic data are made available via dbGaP through requests to the data custodians.|
|Studies a U.S. FDA-regulated Drug Product:||Yes|
|Studies a U.S. FDA-regulated Device Product:||No|
Genital Neoplasms, Male
Neoplasms by Site
Genital Diseases, Male
Male Urogenital Diseases
Molecular Mechanisms of Pharmacological Action