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68Ga-PSMA PET/CT in Prostate Cancer

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ClinicalTrials.gov Identifier: NCT03001869
Recruitment Status : Enrolling by invitation
First Posted : December 23, 2016
Last Update Posted : April 4, 2019
Sponsor:
Information provided by (Responsible Party):
Stephan Probst, Sir Mortimer B. Davis - Jewish General Hospital

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.

Condition or disease Intervention/treatment Phase
Prostate Cancer Drug: 68Ga-HBED-CC-PSMA PET/CT Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1500 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: The Safety and Efficacy of 68Ga-HBED-CC-PSMA PET/CT in Prostate Cancer
Actual Study Start Date : July 1, 2017
Estimated Primary Completion Date : July 2022
Estimated Study Completion Date : July 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

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 Name: 68Ga-PSMA-11




Primary Outcome Measures :
  1. Safety of Ga68-PSMA PET/CT imaging as measured by the incidence of adverse events (AE) [ Time Frame: 7 days ]
  2. 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 ]
  3. 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 ]


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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

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)

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): NCT03001869


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, Chief of Nuclear Medicine, Sir Mortimer B. Davis - Jewish General Hospital
ClinicalTrials.gov Identifier: NCT03001869     History of Changes
Other Study ID Numbers: 16-293
First Posted: December 23, 2016    Key Record Dates
Last Update Posted: April 4, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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

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