68Ga-PSMA PET/CT in Prostate Cancer

The Safety and Efficacy of 68Ga-HBED-CC-PSMA PET/CT in Prostate Cancer

The objectives of this study are to replicate the safety and efficacy of 68Ga-PSMA PET/CT and as a diagnostic and decision making tool in the management prostate cancer patients.The primary endpoints of the study are the incidence of adverse events (AE) in the study population up to 7 days following the scan, and the sensitivity and specificity of 68Ga-PSMA PET/CT vs CT on a per-patient and per-lesion basis.

Study Overview

• Status: Completed
• Conditions: Prostate Cancer
• Intervention / Treatment: Drug: 68Ga-HBED-CC-PSMA PET/CT

Detailed Description

Positron emission tomography / computer tomography (PET/CT) is a nuclear medicine diagnostic imaging procedure based on the measurement of positron emission from radiolabeled tracer molecules in vivo. A radiotracer in use today is 68Ga-HBED-CC-PSMA (DKFZ-11) - hereinafter abbreviated 68Ga-PSMA - which is a radiolabeled urea-based ligand for prostate specific membrane antigen (PSMA) PET/CT. Imaging with 68Ga-PSMA PET is used to characterize and localize prostate cancer in humans in vivo. There is extensive data in the literature showing the value of 68Ga-PSMA PET/CT imaging in accurately staging and restaging prostate cancer. The objectives of this study are to replicate the safety and efficacy of 68Ga-PSMA PET/CT and to establish our ability to reproduce results from the literature using 68Ga-PSMA PET/CT as a diagnostic and decision making tool in the management prostate cancer patients. During the study eligible prostate cancer patients will undergo one 68Ga-PSMA PET/CT. The primary endpoints of the study are the incidence of adverse events (AE) in the study population up to 7 days following the scan, and the sensitivity and specificity of 68Ga-PSMA PET/CT vs CT on a per-patient and per-lesion basis.

• Study Type: Interventional
• Enrollment (Actual): 540
• Phase: Phase 3

Contacts and Locations

Study Locations

• Canada
  • Quebec
    • Montreal, Quebec, Canada, H3T1E2
      • Jewish General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 120 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Global Inclusion Criteria:

• Resident of Canada
• Male sex
• Age 18 years or older
• Previously diagnosed with prostate cancer, under referring physician's care
• ECOG performance status 0 - 3, inclusive
• Able to understand and provide written informed consent
• Able to tolerate the physical/logistical requirements of a PET/CT scan including lying supine (or prone) for up to 40 minutes and tolerating intravenous cannulation

Global Exclusion Criteria:

• Patients who are medically unstable (e.g. acute cardiac or respiratory distress or hypotensive)
• Patients who exceed the safe weight limit of the PET/CT bed (usually approximately 400 lbs.) or who cannot fit through the PET/CT bore (usually approximately 70 cm diameter)
• Patients with unmanageable claustrophobia

Clinical Indication Criteria Subgroups:

• BCR: Biochemical recurrence as defined by serum PSA > 0.1 ng/ml following either radical prostatectomy or curative-intent radiotherapy or other prostate-ablative definitive management

• HRS: Staging of high risk patients as defined by any one of the following:

  • Gleason score > 7
  • Serum PSA > 10 ng/ml
  • T stage of T3 or greater on TNM staging
  • Equivocal conventional staging such as CT, MRI or bone scan
  • Clinical suspicion of advance stage disease (e.g. bone pain)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 68Ga-PSMA PET/CT; 68Ga-HBED-CC-PSMA PET/CT	Drug: 68Ga-HBED-CC-PSMA PET/CT; 68Ga-HBED-CC-PSMA PET/CT Scan; Other Names: 68Ga-PSMA-11

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Safety of Ga68-PSMA PET/CT imaging as measured by the incidence of adverse events (AE)	7 days
Efficacy of Ga68-PSMA PET/CT imaging as measured by sensitivity and specificity vs CT on a per patient basis as compared to standard of truth	12 months
Efficacy of Ga68-PSMA PET/CT imaging as measured by sensitivity and specificity vs CT on a per lesion basis as compared to standard of truth	12 months

Collaborators and Investigators

• Sponsor: Sir Mortimer B. Davis - Jewish General Hospital

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2017
• Primary Completion (Actual): July 1, 2023
• Study Completion (Actual): July 1, 2023

Study Registration Dates

• First Submitted: December 21, 2016
• First Submitted That Met QC Criteria: December 21, 2016
• First Posted (Estimated): December 23, 2016

Study Record Updates

• Last Update Posted (Actual): November 27, 2023
• Last Update Submitted That Met QC Criteria: November 22, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Urogenital Diseases; Male Urogenital Diseases; Genital Diseases, Male; Genital Diseases; Prostatic Neoplasms; Molecular Mechanisms of Pharmacological Action; Radiopharmaceuticals; Gallium 68 PSMA-11
• Other Study ID Numbers: 16-293

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No