Pilot Study of 18F-DCFPyL PET/CT in the Evaluation of Men With an Elevated PSA Following Radical Prostatectomy

Study Overview
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Brief Summary
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This pilot study aims to investigate the diagnostic utility of 18F-DCFPyL, a novel low-molecular weight PSMA PET/CT imaging agent, in men with an elevated PSA following radical prostatectomy.

Detailed Description
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18F-DCFPyL is a novel low-molecular weight PSMA imaging agent. A recent study of patients with metastatic prostate cancer found that PSMA PET/CT identified more sites of disease than conventional imaging with CT, MRI and bone scan. In this study we aim to investigate 18F-DCFPyL PET/CT in patients with an elevated PSA following radical prostatectomy. During the course of this study, patients will undergo two 18F-DCPyL PET/CT scans. The first scan will take place within 45 days of staging imaging and the second will take place following six months of standard of care therapy.

Official Title
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Pilot Study of 18F-DCFPyL PET/CT in the Evaluation of Men With an Elevated PSA Following Radical Prostatectomy

Conditions
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Adenocarcinoma of the Prostate

Intervention / Treatment
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* Drug: 18F-DCFPyL


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥18 years History of adenocarcinoma of the prostate treated with radical prostatectomy Serum PSA level ≥0.2 ng/mL at least 45 days prior to study enrollment Completed staging evaluation with bone scan as well as CT or MRI of the abdomen and pelvis at least 45 days prior to study enrollment Exclusion Criteria: Intention to enroll in a blinded therapeutic clinical trial History of other malignancy diagnosed within the last three years (the exception of squamous cell or basal cell carcinoma of the skin)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 18F-DCFPyL PET/CT<br>Men with an elevated PSA following radical prostatectomy imaged with 18F-DCFPyL PET/CT | Drug: 18F-DCFPyL<br>* 18F-DCFPyL PET/CT<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Putative Sites of Metastatic Disease as Determined by 18F-DCFPyL PET/CT | Number of sites with 18F-DCFPyL uptake consistent with prostate cancer. | 6 months | 
| Location of Putative Sites of Metastatic Disease as Determined by 18F-DCFPyL PET/CT | Location of uptake of 18F-DCFPyL consistent with prostate cancer. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation of 18F-DCFPyL PET/CT Findings With Prostate Specific Antigen (PSA) Levels | Number of participants with PSA 0.2-1.0ng/mL OR PSA >1.0ng/mL with at least 1 site of uptake of 18F-DCFPyL consistent with prostate cancer. | 6 months | 
| Correlation of Findings on 18FDCFPyL PET/CT With Those Found on Conventional Imaging (Bone Scan and Cross-sectional Imaging) | Number of sites with uptake on 18F-DCFPyL PET/CT and corresponding lesions identified on conventional imaging. | 6 months | 
| Correlation of Findings on 18F-DCFPyL PET/CT With Tissue Histology and PSMA Expression of Biopsied/Resected Pathology Specimens | Number of sites with 18F-DCFPyL uptake from which biopsy specimens show PSMA expression. | 6 months |