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

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.

Study Overview

• Status: Completed
• Conditions: Adenocarcinoma of the Prostate
• Intervention / Treatment: Drug: 18F-DCFPyL

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 Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21287
      • SKCCC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

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

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Time Frame
Correlation of 18F-DCFPyL PET/CT Findings With Time to Disease Progression	6 months
Assessment of Treatment Response by 18F-DCFPyL PET/CT	6 months

Collaborators and Investigators

• Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Study record dates

Study Major Dates

• Study Start (Actual): June 2, 2015
• Primary Completion (Actual): November 4, 2016
• Study Completion (Actual): March 4, 2019

Study Registration Dates

• First Submitted: May 28, 2015
• First Submitted That Met QC Criteria: August 12, 2015
• First Posted (Estimate): August 14, 2015

Study Record Updates

• Last Update Posted (Actual): January 31, 2020
• Last Update Submitted That Met QC Criteria: January 22, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Carcinoma; Neoplasms, Glandular and Epithelial; Adenocarcinoma
• Other Study ID Numbers: J1545; IRB00062296 (Other Identifier: JHMIRB)