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Trial record 1 of 26 for:    psma | Prostate Cancer | Canada
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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

Tracking Information
First Submitted Date  ICMJE December 21, 2016
First Posted Date  ICMJE December 23, 2016
Last Update Posted Date April 4, 2019
Actual Study Start Date  ICMJE July 1, 2017
Estimated Primary Completion Date July 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 21, 2016)
  • Safety of Ga68-PSMA PET/CT imaging as measured by the incidence of adverse events (AE) [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 12 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03001869 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 68Ga-PSMA PET/CT in Prostate Cancer
Official Title  ICMJE The Safety and Efficacy of 68Ga-HBED-CC-PSMA PET/CT in Prostate Cancer
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE Prostate Cancer
Intervention  ICMJE Drug: 68Ga-HBED-CC-PSMA PET/CT
68Ga-HBED-CC-PSMA PET/CT Scan
Other Name: 68Ga-PSMA-11
Study Arms  ICMJE Experimental: 68Ga-PSMA PET/CT
68Ga-HBED-CC-PSMA PET/CT
Intervention: Drug: 68Ga-HBED-CC-PSMA PET/CT
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Enrolling by invitation
Estimated Enrollment  ICMJE
 (submitted: December 21, 2016)
1500
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 2023
Estimated Primary Completion Date July 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years to 120 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03001869
Other Study ID Numbers  ICMJE 16-293
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Stephan Probst, Sir Mortimer B. Davis - Jewish General Hospital
Study Sponsor  ICMJE Sir Mortimer B. Davis - Jewish General Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Sir Mortimer B. Davis - Jewish General Hospital
Verification Date April 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP