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

NCT02796807 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 88

Last updated 2018-03-06

No results posted yet for this study

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

DRUG

68Ga-HBED-CC-PSMA (DKFZ-11) PET/CT

Sponsors & Collaborators

  • Sir Mortimer B. Davis - Jewish General Hospital

    lead OTHER

Study Design

Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
120 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-05-31
Primary Completion
2017-12-31
Completion
2017-12-31

Countries

  • Canada

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02796807 on ClinicalTrials.gov