Prostate Cancer Clinical Trial
Official title:
Correlation Between SUV on 18F-DCFPyL PET/CT and Gleason Score in Prostate Cancer
NCT number | NCT03001895 |
Other study ID # | 16-291 |
Secondary ID | |
Status | Completed |
Phase | Phase 2 |
First received | |
Last updated | |
Start date | July 1, 2017 |
Est. completion date | October 5, 2018 |
Verified date | February 2019 |
Source | Sir Mortimer B. Davis - Jewish General Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 120 |
Est. completion date | October 5, 2018 |
Est. primary completion date | October 5, 2018 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 18 Years to 120 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Canada | Jewish General Hospital | Montreal | Quebec |
Lead Sponsor | Collaborator |
---|---|
Sir Mortimer B. Davis - Jewish General Hospital |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | SUVmax on 18F-DCFPyL PET/CT | Maximum standard uptake value (SUVmax) on 18F-DCFPyL PET/CT in locoregional and metastatic prostate cancer | 24 hours |
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