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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
Sponsor:
Information provided by (Responsible Party):
Stephan Probst, Sir Mortimer B. Davis - Jewish General Hospital

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.


Condition or disease Intervention/treatment Phase
Prostate Cancer Drug: 68Ga-HBED-CC-PSMA (DKFZ-11) PET/CT Phase 2

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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arm Intervention/treatment
Experimental: 68Ga-HBED-CC-PSMA (DKFZ-11) PET/CT Drug: 68Ga-HBED-CC-PSMA (DKFZ-11) PET/CT



Primary Outcome Measures :
  1. SUVmax on 68Ga-PSMA PET/CT in locoregional and metastatic prostate cancer [ Time Frame: Through study completion, one day ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 120 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

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


Locations
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Canada, Quebec
Jewish General Hospital
Montreal, Quebec, Canada, H3T1E2
Sponsors and Collaborators
Sir Mortimer B. Davis - Jewish General Hospital

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Responsible Party: Stephan Probst, MD, Sir Mortimer B. Davis - Jewish General Hospital
ClinicalTrials.gov Identifier: NCT02796807     History of Changes
Other Study ID Numbers: 16-052
First Posted: June 13, 2016    Key Record Dates
Last Update Posted: March 6, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Edetic Acid
Anticoagulants
Calcium Chelating Agents
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action