Correlation Between SUV on 18F-DCFPyL PET/CT and Gleason Score in Prostate Cancer
1 other identifier
interventional
120
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 prostate-cancer
Started Jul 2017
Shorter than P25 for phase_2 prostate-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 21, 2016
CompletedFirst Posted
Study publicly available on registry
December 23, 2016
CompletedStudy Start
First participant enrolled
July 1, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 5, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
October 5, 2018
CompletedFebruary 15, 2019
February 1, 2019
1.3 years
December 21, 2016
February 12, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
SUVmax on 18F-DCFPyL PET/CT
Maximum standard uptake value (SUVmax) on 18F-DCFPyL PET/CT in locoregional and metastatic prostate cancer
24 hours
Study Arms (1)
18F-DCFPyL PET/CT
EXPERIMENTAL18F-DCFPyL PET/CT Scan
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Jewish General Hospital
Montreal, Quebec, H3T1E2, Canada
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Chief of Nuclear Medicine
Study Record Dates
First Submitted
December 21, 2016
First Posted
December 23, 2016
Study Start
July 1, 2017
Primary Completion
October 5, 2018
Study Completion
October 5, 2018
Last Updated
February 15, 2019
Record last verified: 2019-02
Data Sharing
- IPD Sharing
- Will not share