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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

Tracking Information
First Submitted Date  ICMJE November 9, 2021
First Posted Date  ICMJE December 2, 2021
Last Update Posted Date May 11, 2022
Actual Study Start Date  ICMJE February 10, 2022
Estimated Primary Completion Date July 31, 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 18, 2021)
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)
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 18, 2021)
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 18F-PSMA PET and MRI in the Primary Staging of Prostate Cancer Patients
Official Title  ICMJE Assessing 18F-PSMA-1007 Positron Emission Tomography and Magnetic Resonance Imaging in the Primary Staging of Prostate Cancer Patients
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).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE Prostate Cancer
Intervention  ICMJE 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
Study Arms  ICMJE Not Provided
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 Recruiting
Estimated Enrollment  ICMJE
 (submitted: November 18, 2021)
150
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2024
Estimated Primary Completion Date July 31, 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
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
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05141760
Other Study ID Numbers  ICMJE HREBA.CC-21-0073
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party University of Alberta
Original Responsible Party Same as current
Current Study Sponsor  ICMJE University of Alberta
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Canadian Urological Association Scholarship Foundation
Investigators  ICMJE Not Provided
PRS Account University of Alberta
Verification Date November 2021

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