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18F-PSMA PET and MRI in the Primary Staging of Prostate Cancer Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05141760
Recruitment Status : Recruiting
First Posted : December 2, 2021
Last Update Posted : May 11, 2022
Sponsor:
Collaborator:
Canadian Urological Association Scholarship Foundation
Information provided by (Responsible Party):
University of Alberta

Brief Summary:
This prospective phase II study assesses the accuracy of second generation prostate specific membrane antigen (PSMA) positron emission tomography (PET; utilizing 18F-PSMA-1007)) and multiparametric magnetic resonance imaging (MRI) for locoregional staging of clinically significant prostate cancer in men undergoing radical prostatectomy and bilateral pelvic lymph node dissection. The design will be a multicenter validating-paired cohort study using radical prostatectomy and pelvic lymph node dissection as the gold standard comparator. Each patient will undergo both 18F-PSMA-1007 PET and 3T MRI allowing comparison of each imaging modality within each subject. Furthermore, PET and MRI will be compared to standard-of-care imaging techniques (CT abdomen/pelvis and 99mTc-MDP Bone scan).

Condition or disease Intervention/treatment Phase
Prostate Cancer Diagnostic Test: PSMA-1007 Positron Emission Tomography (PET) scan and 3T Magnetic Resonance Imaging (MRI) Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Assessing 18F-PSMA-1007 Positron Emission Tomography and Magnetic Resonance Imaging in the Primary Staging of Prostate Cancer Patients
Actual Study Start Date : February 10, 2022
Estimated Primary Completion Date : July 31, 2024
Estimated Study Completion Date : December 31, 2024

Resource links provided by the National Library of Medicine



Intervention Details:
  • Diagnostic Test: PSMA-1007 Positron Emission Tomography (PET) scan and 3T Magnetic Resonance Imaging (MRI)
    Additional staging PET and MRI scan prior to prostatectomy and lymph node dissection


Primary Outcome Measures :
  1. Tumor T-staging [ Time Frame: Through study completion, this is expected to be reviewed within 1 year of imaging ]
    Differentiate Unilateral vs. Bilateral Tumor (i.e. T2a vs. T2b), Identify extracapsular extension (T3a) or Seminal vesicle invasion (T3b)


Secondary Outcome Measures :
  1. Sensitivity of PSMA-1007 PET [ Time Frame: Through study completion, this is expected to be reviewed within 1 year of imaging ]
    Compare final histology against PSMA-1007 PET

  2. Sensitivity of MRI [ Time Frame: Through study completion, this is expected to be reviewed within 1 year of imaging ]
    Compare final histology against MR imaging

  3. Specificity of PSMA-1007 PET [ Time Frame: Through study completion, this is expected to be reviewed within 1 year of imaging ]
    Compare final histology against PSMA-1007 PET

  4. Specificity of MRI [ Time Frame: Through study completion, this is expected to be reviewed within 1 year of imaging ]
    Compare final histology against MR imaging

  5. Negative Predictive Value of PSMA-1007 PET [ Time Frame: Through study completion, this is expected to be reviewed within 1 year of imaging ]
    Compare final histology against PSMA-1007 PET

  6. Negative Predictive Value of MRI [ Time Frame: Through study completion, this is expected to be reviewed within 1 year of imaging ]
    Compare final histology against MR imaging

  7. Positive Predictive Value of PSMA-1007 PET [ Time Frame: Through study completion, this is expected to be reviewed within 1 year of imaging ]
    Compare final histology against PSMA-1007 PET

  8. Positive Predictive Value of MRI [ Time Frame: Through study completion, this is expected to be reviewed within 1 year of imaging ]
    Compare final histology against MRI

  9. Nodal Staging [ Time Frame: Through study completion, this is expected to be reviewed within 1 year of imaging ]
    Accuracy of nodal disease on PSMA-1007 PET and MRI compared to bone scan + CT

  10. Metastatic Staging [ Time Frame: Through study completion, this is expected to be reviewed within 1 year of imaging ]
    Accuracy of PSMA-1007 PET and MRI compared to bone scan + CT

  11. Longest Tumor diameter [ Time Frame: Through study completion, this is expected to be reviewed within 1 year of imaging ]
    Compare final histology against PSMA-1007 PET and MRI measurements

  12. Identification of dominant lesion [ Time Frame: Through study completion, this is expected to be reviewed within 1 year of imaging ]
    Compare rate of dominant lesion identification of PSMA-1007 PET and MRI against final histology

  13. Identification of non-dominant lesion [ Time Frame: Through study completion, this is expected to be reviewed within 1 year of imaging ]
    Compare rate of non-dominant lesion identification of PSMA-1007 PET and MRI against final histology



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients or their legal medical decision makers will sign an informed consent prior to entering the study.
  2. Adult patient (≥ 18 years old) with a diagnosis of at least Gleason Grade Group 2 prostate cancer.
  3. Appropriate staging investigations have been performed prior to the participation in the study (i.e. CT abdomen/pelvis and 99mTc-MDP bone scan)

Exclusion Criteria:

  1. Unable to obtain consent
  2. Weight >250 kg (weight limitation of scanners)
  3. Unable to lie flat for 30 minutes to complete the PET or MRI imaging
  4. Severe claustrophobia precluding image acquisition
  5. Lack of intravenous access
  6. Non-MRI compatible pacemaker or hardware
  7. eGFR < 40 mL/min/1.73 m2 and/or a history of a severe reaction to MRI contrast
  8. Prior androgen deprivation therapy

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): NCT05141760


Contacts
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Contact: Alexander Tamm, MD, FRCPC 780-407-6907 astamm@ualberta.ca
Contact: Adam Kinnaird, MD, PhD, FRCSC 780-407-5800 ext 321 ask@ualberta.ca

Locations
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Canada, Alberta
University of Alberta Recruiting
Edmonton, Alberta, Canada, T6G 2B7
Contact: Alexander Tamm, MD FRCPC       astamm@ualberta.ca   
Contact: Adam Kinnaird, MD PhD FRCSC       ask@ualberta.ca   
Sponsors and Collaborators
University of Alberta
Canadian Urological Association Scholarship Foundation
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Responsible Party: University of Alberta
ClinicalTrials.gov Identifier: NCT05141760    
Other Study ID Numbers: HREBA.CC-21-0073
First Posted: December 2, 2021    Key Record Dates
Last Update Posted: May 11, 2022
Last Verified: November 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Prostatic Diseases