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

Primary Purpose

Adenocarcinoma of the Prostate

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
18F-DCFPyL
Sponsored by
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Adenocarcinoma of the Prostate

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

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)

Sites / Locations

  • SKCCC

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

18F-DCFPyL PET/CT

Arm Description

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

Outcomes

Primary Outcome Measures

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.
Location of Putative Sites of Metastatic Disease as Determined by 18F-DCFPyL PET/CT
Location of uptake of 18F-DCFPyL consistent with prostate cancer.

Secondary Outcome Measures

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.
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.
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.

Full Information

First Posted
May 28, 2015
Last Updated
January 22, 2020
Sponsor
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
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1. Study Identification

Unique Protocol Identification Number
NCT02523924
Brief Title
Pilot Study of 18F-DCFPyL PET/CT in the Evaluation of Men With an Elevated PSA Following Radical Prostatectomy
Official Title
Pilot Study of 18F-DCFPyL PET/CT in the Evaluation of Men With an Elevated PSA Following Radical Prostatectomy
Study Type
Interventional

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
June 2, 2015 (Actual)
Primary Completion Date
November 4, 2016 (Actual)
Study Completion Date
March 4, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adenocarcinoma of the Prostate

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
18F-DCFPyL PET/CT
Arm Type
Experimental
Arm Description
Men with an elevated PSA following radical prostatectomy imaged with 18F-DCFPyL PET/CT
Intervention Type
Drug
Intervention Name(s)
18F-DCFPyL
Intervention Description
18F-DCFPyL PET/CT
Primary Outcome Measure Information:
Title
Number of Putative Sites of Metastatic Disease as Determined by 18F-DCFPyL PET/CT
Description
Number of sites with 18F-DCFPyL uptake consistent with prostate cancer.
Time Frame
6 months
Title
Location of Putative Sites of Metastatic Disease as Determined by 18F-DCFPyL PET/CT
Description
Location of uptake of 18F-DCFPyL consistent with prostate cancer.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Correlation of 18F-DCFPyL PET/CT Findings With Prostate Specific Antigen (PSA) Levels
Description
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
Title
Correlation of Findings on 18FDCFPyL PET/CT With Those Found on Conventional Imaging (Bone Scan and Cross-sectional Imaging)
Description
Number of sites with uptake on 18F-DCFPyL PET/CT and corresponding lesions identified on conventional imaging.
Time Frame
6 months
Title
Correlation of Findings on 18F-DCFPyL PET/CT With Tissue Histology and PSMA Expression of Biopsied/Resected Pathology Specimens
Description
Number of sites with 18F-DCFPyL uptake from which biopsy specimens show PSMA expression.
Time Frame
6 months
Other Pre-specified Outcome Measures:
Title
Correlation of 18F-DCFPyL PET/CT Findings With Time to Disease Progression
Time Frame
6 months
Title
Assessment of Treatment Response by 18F-DCFPyL PET/CT
Time Frame
6 months

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
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)
Facility Information:
Facility Name
SKCCC
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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