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

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins50 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Adenocarcinoma of the Prostate

Interventions

18F-DCFPyLDRUG

18F-DCFPyL PET/CT

Eligibility

Sex: MALEMin age: 18 YearsMax age: 100 Years

Medical Language ↔ Plain English

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)

Locations (1)

SKCCC

Baltimore, Maryland, United States

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: 6 months

Secondary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: 6 months

Data from ClinicalTrials.gov

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