F18 DCFPyL PET/CT in Imaging Participants With Recurrent Prostate Cancer

Study Overview
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Brief Summary
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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
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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.

Official Title
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18F-DCFPyL PET/CT in the Evaluation of Patients With Biochemical Recurrence of Prostate Cancer and Non-Contributory CT Scans

Conditions
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Prostate Adenocarcinoma, PSA Level Greater Than 0.2, PSA Level Greater Than or Equal to Two, PSA Progression, Recurrent Prostate Carcinoma

Intervention / Treatment
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* Procedure: Computed Tomography
* Radiation: Fluorine F 18 DCFPyL
* Other: Laboratory Biomarker Analysis
* Procedure: Positron Emission Tomography


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Computed Tomography|Undergo 18F-DCFPyL PET/CT|
|Radiation: Fluorine F 18 DCFPyL|Given IV|
|Other: Laboratory Biomarker Analysis|Correlative studies|
|Procedure: Positron Emission Tomography|Undergo 18F-DCFPyL PET/CT|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |