Correlation Between SUV on 18F-DCFPyL PET/CT and Gleason Score in Prostate Cancer
Primary Purpose
Prostate Cancer
Status
Completed
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
18F-DCFPyL PET/CT
Sponsored by
About this trial
This is an interventional diagnostic trial for Prostate Cancer
Eligibility Criteria
Inclusion Criteria:
- Resident of Canada
- Male sex
- Age 18 years or older
- Previous diagnosis of prostate cancer with Gleason Score available
- ECOG performance status 0 - 3, inclusive
- Able to understand and provide written informed consent
- Under referring physician's care
- Able to tolerate the physical/logistical requirements of a PET/CT scan including lying supine for up to 40 minutes with the arms above the head and tolerating intravenous cannulation
Exclusion Criteria:
- Medically unstable patients (e.g. acute cardiac or respiratory distress or hypotensive, etc.)
- Patients who exceed the safe weight limit of the PET/CT bed (200 kg) or who cannot fit through the PET/CT bore (70 cm diameter)
- Patients with unmanageable claustrophobia
Sites / Locations
- Jewish General Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
18F-DCFPyL PET/CT
Arm Description
18F-DCFPyL PET/CT Scan
Outcomes
Primary Outcome Measures
SUVmax on 18F-DCFPyL PET/CT
Maximum standard uptake value (SUVmax) on 18F-DCFPyL PET/CT in locoregional and metastatic prostate cancer
Secondary Outcome Measures
Full Information
NCT ID
NCT03001895
First Posted
December 21, 2016
Last Updated
February 12, 2019
Sponsor
Sir Mortimer B. Davis - Jewish General Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03001895
Brief Title
Correlation Between SUV on 18F-DCFPyL PET/CT and Gleason Score in Prostate Cancer
Official Title
Correlation Between SUV on 18F-DCFPyL PET/CT and Gleason Score in Prostate Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
July 1, 2017 (Actual)
Primary Completion Date
October 5, 2018 (Actual)
Study Completion Date
October 5, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sir Mortimer B. Davis - Jewish General Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Prostate specific membrane antigen (PSMA) is a unique membrane bound glycoprotein, which is overexpressed manifold on prostate cancer cells and is well-characterized as an imaging biomarker of prostate cancer. Positron emission tomography / computer tomography (PET/CT) is a nuclear medicine procedure based on the measurement of positron emission from radiolabeled tracer molecules. 18F-DCFPyL is a tracer for prostate cancer PET imaging which binds to PSMA. The strength of functional imaging methods is in distinguishing tissues according to metabolism rather than structure. Studies have shown that PET/CT imaging with 18F-DCFPyL can detect prostate cancer lesions with excellent contrast and a high detection rate even when the level of prostate specific antigen is low.
The objective of this study is to evaluate if the patient-wide SUVmax on 18F-DCFPyL PET/CT in locoregional and metastatic prostate cancer correlates with histopathologic Gleason score at initial biopsy. It is hypothesized that SUVmax will correlate positively with Gleason score. This is of interest because non-invasive risk stratification may be possible in the future.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
120 (Actual)
8. Arms, Groups, and Interventions
Arm Title
18F-DCFPyL PET/CT
Arm Type
Experimental
Arm Description
18F-DCFPyL PET/CT Scan
Intervention Type
Drug
Intervention Name(s)
18F-DCFPyL PET/CT
Intervention Description
18F-DCFPyL PET/CT
Primary Outcome Measure Information:
Title
SUVmax on 18F-DCFPyL PET/CT
Description
Maximum standard uptake value (SUVmax) on 18F-DCFPyL PET/CT in locoregional and metastatic prostate cancer
Time Frame
24 hours
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
120 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Resident of Canada
Male sex
Age 18 years or older
Previous diagnosis of prostate cancer with Gleason Score available
ECOG performance status 0 - 3, inclusive
Able to understand and provide written informed consent
Under referring physician's care
Able to tolerate the physical/logistical requirements of a PET/CT scan including lying supine for up to 40 minutes with the arms above the head and tolerating intravenous cannulation
Exclusion Criteria:
Medically unstable patients (e.g. acute cardiac or respiratory distress or hypotensive, etc.)
Patients who exceed the safe weight limit of the PET/CT bed (200 kg) or who cannot fit through the PET/CT bore (70 cm diameter)
Patients with unmanageable claustrophobia
Facility Information:
Facility Name
Jewish General Hospital
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3T1E2
Country
Canada
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Correlation Between SUV on 18F-DCFPyL PET/CT and Gleason Score in Prostate Cancer
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