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

Not Applicable

Completed

• Conditions: Adenocarcinoma of the Prostate
• Interventions: Drug: 18F-DCFPyL

• Registration Number: NCT02523924
• Lead Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

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.

Study Timeline

• Study First Submitted: 2015-05-28
• Study Start: 2015-06-02
• Study First Submitted QC: 2015-08-12
• Study First Posted: 2015-08-14
• Primary Completion: 2016-11-04
• Study Completion: 2019-03-04
• Status Verified: 2020-01
• Results First Submitted: 2020-01-22
• Results First Submitted QC: 2020-01-22
• Last Update Submitted: 2020-01-22
• Results First Posted: 2020-01-31
• Last Update Posted: 2020-01-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 50

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
18F-DCFPyL PET/CT	18F-DCFPyL	Men with an elevated PSA following radical prostatectomy imaged with 18F-DCFPyL PET/CT

Primary Outcome Measures

Name	Time	Method
Number of Putative Sites of Metastatic Disease as Determined by 18F-DCFPyL PET/CT	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	6 months	Location of uptake of 18F-DCFPyL consistent with prostate cancer.

Secondary Outcome Measures

Name	Time	Method
Correlation of Findings on 18FDCFPyL PET/CT With Those Found on Conventional Imaging (Bone Scan and Cross-sectional Imaging)	6 months	Number of sites with uptake on 18F-DCFPyL PET/CT and corresponding lesions identified on conventional imaging.
Correlation of 18F-DCFPyL PET/CT Findings With Prostate Specific Antigen (PSA) Levels	6 months	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.
Correlation of Findings on 18F-DCFPyL PET/CT With Tissue Histology and PSMA Expression of Biopsied/Resected Pathology Specimens	6 months	Number of sites with 18F-DCFPyL uptake from which biopsy specimens show PSMA expression.

Trial Locations

Locations (1)

SKCCC; 🇺🇸 Baltimore, Maryland, United States