Correlation Between SUV on 68Ga-HBED-CC-PSMA and Gleason Score in Prostate Cancer

Study Overview
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Brief Summary
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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.

Official Title
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Correlation Between SUV on 68Ga-HBED-CC-PSMA and Gleason Score in Prostate Cancer

Conditions
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Prostate Cancer

Intervention / Treatment
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* Drug: 68Ga-HBED-CC-PSMA (DKFZ-11) PET/CT


Participation Criteria
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Eligibility Criteria
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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 Referred by a treating physician Able to tolerate the physical/logistical requirements of a PET/CT scan including lying supine for up to 45 minutes with the arms above the head and tolerating intravenous cannulation for injection of the study drug 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 who are claustrophobic

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 120 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 68Ga-HBED-CC-PSMA (DKFZ-11) PET/CT<br> | Drug: 68Ga-HBED-CC-PSMA (DKFZ-11) PET/CT<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SUVmax on 68Ga-PSMA PET/CT in locoregional and metastatic prostate cancer |  | Through study completion, one day |