Correlation Between SUV on 68Ga-HBED-CC-PSMA and Gleason Score in Prostate Cancer
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|ClinicalTrials.gov Identifier: NCT02796807|
Recruitment Status : Completed
First Posted : June 13, 2016
Last Update Posted : March 6, 2018
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.
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.
|Condition or disease||Intervention/treatment||Phase|
|Prostate Cancer||Drug: 68Ga-HBED-CC-PSMA (DKFZ-11) PET/CT||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||88 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Basic Science|
|Official Title:||Correlation Between SUV on 68Ga-HBED-CC-PSMA and Gleason Score in Prostate Cancer|
|Actual Study Start Date :||May 2016|
|Actual Primary Completion Date :||December 2017|
|Actual Study Completion Date :||December 2017|
|Experimental: 68Ga-HBED-CC-PSMA (DKFZ-11) PET/CT||
Drug: 68Ga-HBED-CC-PSMA (DKFZ-11) PET/CT
- SUVmax on 68Ga-PSMA PET/CT in locoregional and metastatic prostate cancer [ Time Frame: Through study completion, one day ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02796807
|Jewish General Hospital|
|Montreal, Quebec, Canada, H3T1E2|