Prostate Cancer Clinical Trial
F18 DCFPyL PET/CT in Imaging Participants With Recurrent Prostate Cancer
Summary
This study provides fluorine F 18 DCFPyL positron emission tomography/computed tomography (PET/CT) to participants with prostate cancer that has come back. Diagnostic procedures, such as fluorine F 18 DCFPyL PET/CT, may help find and diagnose prostate cancer and find out how far the disease has spread.
Full Description
PRIMARY OBJECTIVES:
I. To evaluate fluorine F 18 DCFPyL (18F-DCFPyL) PET/CT for detection of recurrent prostate cancer after initial therapy in patients with elevated prostate-specific antigen (PSA).
OUTLINE:
Participants receive fluorine F 18 DCFPyL intravenously (IV). After 60-120 minutes, participants undergo whole body PET/CT. Immediately after the first scan, participants may undergo a second PET/CT without receiving fluorine F 18 DCFPyL.
After completion of study, participants are followed up at 24-72 hours.
Eligibility Criteria
Inclusion Criteria:
Biopsy proven prostate adenocarcinoma
Rising PSA after definitive therapy with prostatectomy or radiation therapy (external beam or brachytherapy)
Post radical prostatectomy (RP) - American Urological Association (AUA) recommendation
PSA greater than 0.2 ng/mL measured after at least 6 weeks from radical prostatectomy
Confirmatory persistent PSA greater than 0.2 ng/mL (total of two PSA measurements greater than 0.2 ng/mL)
Post-radiation therapy - American Society for Radiation Oncology (ASTRO) - Phoenix consensus definition
A rise of PSA measurement of 2 or more ng/mL over the nadir
Able to provide written consent
Karnofsky performance status of > 50 (or Eastern Cooperative Oncology Group [ECOG] / World Health Organization [WHO] equivalent)
Exclusion Criteria:
Unable to provide informed consent
Inability to lie still for the entire imaging time
Inability to complete the needed investigational and standard-of-care imaging examinations due to other reasons (severe claustrophobia, radiation phobia, etc.)
Any additional medical condition, serious intercurrent illness, or other extenuating circumstance that, in the opinion of the Investigator, may significantly interfere with study compliance
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There is 1 Location for this study
Palo Alto California, 94304, United States
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