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

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.

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Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year–120 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 2

Primary location

Jewish General Hospital

Montreal, Quebec, H3T1E2, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Drug

Primary outcomes

SUVmax on 68Ga-PSMA PET/CT in locoregional and metastatic prostate cancer

Time frame: Through study completion, one day

Sponsors and collaborators

Lead sponsor

Sir Mortimer B. Davis - Jewish General Hospital

Other

Registry information

Important dates

Study start: 2016
Primary completion: 2017
Study completion: 2017
First posted: Jun 13, 2016
Registry last updated: Mar 6, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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