Clinical trial NCT02796807: Correlation Between SUV on 68Ga-HBED-CC-PSMA and Gleason Score in Prostate Cancer
Official title: Correlation Between SUV on 68Ga-HBED-CC-PSMA and Gleason Score in Prostate Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Prostate Cancer
Lead sponsor: Sir Mortimer B. Davis - Jewish General Hospital
Sponsor class: OTHER
First posted: 2016-06-13
Enrollment: 88
Sex: MALE
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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.


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

Primary outcomes:
measure: SUVmax on 68Ga-PSMA PET/CT in locoregional and metastatic prostate cancer
timeFrame: Through study completion, one day
Secondary outcomes:
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: Jewish General Hospital
state: Quebec
Study officials:
References: