Trials / Completed
CompletedNCT02796807
Correlation Between SUV on 68Ga-HBED-CC-PSMA and Gleason Score in Prostate Cancer
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 88 (actual)
- Sponsor
- Sir Mortimer B. Davis - Jewish General Hospital · Academic / Other
- Sex
- Male
- Age
- 18 Years – 120 Years
- Healthy volunteers
- Not accepted
Summary
Prostate cancer is the second leading cause of cancer death in North American men older than 50 years. 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. 68Ga-HBED-CC-PSMA (DKFZ-11) (abbreviated 68Ga-PSMA) is a tracer for prostate cancer PET imaging. The strength of functional imaging methods is in distinguishing tissues according to metabolism rather than structure. Studies have shown that PET/CT imaging with 68Ga-PSMA can detect prostate cancer lesions with excellent contrast and a high detection rate even when the level of prostate specific antigen is low. Study Objectives: The objective of this study is to evaluate if the patient-wide SUVmax on 68Ga-PSMA 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. This will be a single-site JGH-only open label study in which one (1) 68Ga-PSMA PET/CT will be performed on study participants. A PET/CT scan takes 2-3 hours.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | 68Ga-HBED-CC-PSMA (DKFZ-11) PET/CT |
Timeline
- Start date
- 2016-05-01
- Primary completion
- 2017-12-01
- Completion
- 2017-12-01
- First posted
- 2016-06-13
- Last updated
- 2018-03-06
Locations
1 site across 1 country: Canada
Source: ClinicalTrials.gov record NCT02796807. Inclusion in this directory is not an endorsement.