18F-DCFPyL PET/CT in the Evaluation of Patients With Biochemical Recurrence of Prostate Cancer and Non-Contributory CT Scans
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Prostate Adenocarcinoma
- Sponsor
- Andrei Iagaru
- Locations
- 1
- Status
- No Longer Available
- Last Updated
- 4 years ago
Overview
Brief 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.
Detailed 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.
Investigators
Andrei Iagaru
Associate Professor of Radiology
Stanford University
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
Outcomes
Primary Outcomes
Not specified