Pilot Study of 18F-DCFPyL PET/CT in the Evaluation of Men With an Elevated PSA Following Radical Prostatectomy
Overview
- Phase
- Not Applicable
- Intervention
- 18F-DCFPyL
- Conditions
- Adenocarcinoma of the Prostate
- Sponsor
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- Number of Putative Sites of Metastatic Disease as Determined by 18F-DCFPyL PET/CT
- Status
- Completed
- Last Updated
- 6 years ago
Overview
Brief Summary
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
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.
Investigators
Eligibility Criteria
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)
Arms & Interventions
18F-DCFPyL PET/CT
Men with an elevated PSA following radical prostatectomy imaged with 18F-DCFPyL PET/CT
Intervention: 18F-DCFPyL
Outcomes
Primary Outcomes
Number of Putative Sites of Metastatic Disease as Determined by 18F-DCFPyL PET/CT
Time Frame: 6 months
Number of sites with 18F-DCFPyL uptake consistent with prostate cancer.
Location of Putative Sites of Metastatic Disease as Determined by 18F-DCFPyL PET/CT
Time Frame: 6 months
Location of uptake of 18F-DCFPyL consistent with prostate cancer.
Secondary Outcomes
- Correlation of Findings on 18FDCFPyL PET/CT With Those Found on Conventional Imaging (Bone Scan and Cross-sectional Imaging)(6 months)
- Correlation of 18F-DCFPyL PET/CT Findings With Prostate Specific Antigen (PSA) Levels(6 months)
- Correlation of Findings on 18F-DCFPyL PET/CT With Tissue Histology and PSMA Expression of Biopsied/Resected Pathology Specimens(6 months)