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

NCT ID: NCT02796807

Last Updated: 2018-03-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 88 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-05-31
• Study Completion Date: 2017-12-31

Brief 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

Prostate Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

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

Intervention Type: DRUG

Interventions

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

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 120 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Sir Mortimer B. Davis - Jewish General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Stephan Probst

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Jewish General Hospital

Montreal, Quebec, Canada

Countries

Canada

Other Identifiers

16-052

Identifier Type: -

Identifier Source: org_study_id