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

NCT ID: NCT02523924

Last Updated: 2020-01-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-06-02
• Study Completion Date: 2019-03-04

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.

Conditions

Adenocarcinoma of the Prostate

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

18F-DCFPyL PET/CT

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

Group Type: EXPERIMENTAL

18F-DCFPyL

Intervention Type: DRUG

18F-DCFPyL PET/CT

Interventions

18F-DCFPyL

18F-DCFPyL PET/CT

Intervention Type: DRUG

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

SKCCC

Baltimore, Maryland, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

IRB00062296

Identifier Type: OTHER

Identifier Source: secondary_id

J1545

Identifier Type: -

Identifier Source: org_study_id