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68Ga-PSMA PET/CT in Prostate Cancer

Primary Purpose

Prostate Cancer

Status
Enrolling by invitation
Phase
Phase 3
Locations
Canada
Study Type
Interventional
Intervention
68Ga-HBED-CC-PSMA PET/CT
Sponsored by
Sir Mortimer B. Davis - Jewish General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Prostate Cancer

Eligibility Criteria

18 Years - 120 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

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)

Sites / Locations

  • Jewish General Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

68Ga-PSMA PET/CT

Arm Description

68Ga-HBED-CC-PSMA PET/CT

Outcomes

Primary Outcome Measures

Safety of Ga68-PSMA PET/CT imaging as measured by the incidence of adverse events (AE)
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
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

Secondary Outcome Measures

Full Information

First Posted
December 21, 2016
Last Updated
October 24, 2022
Sponsor
Sir Mortimer B. Davis - Jewish General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03001869
Brief Title
68Ga-PSMA PET/CT in Prostate Cancer
Official Title
The Safety and Efficacy of 68Ga-HBED-CC-PSMA PET/CT in Prostate Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Enrolling by invitation
Study Start Date
July 1, 2017 (Actual)
Primary Completion Date
July 2025 (Anticipated)
Study Completion Date
July 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sir Mortimer B. Davis - Jewish General Hospital

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
1500 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
68Ga-PSMA PET/CT
Arm Type
Experimental
Arm Description
68Ga-HBED-CC-PSMA PET/CT
Intervention Type
Drug
Intervention Name(s)
68Ga-HBED-CC-PSMA PET/CT
Other Intervention Name(s)
68Ga-PSMA-11
Intervention Description
68Ga-HBED-CC-PSMA PET/CT Scan
Primary Outcome Measure Information:
Title
Safety of Ga68-PSMA PET/CT imaging as measured by the incidence of adverse events (AE)
Time Frame
7 days
Title
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
Time Frame
12 months
Title
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
Time Frame
12 months

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
120 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Facility Information:
Facility Name
Jewish General Hospital
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3T1E2
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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68Ga-PSMA PET/CT in Prostate Cancer

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