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

  • STATUS
    Recruiting
  • End date
    Dec 31, 2024
  • participants needed
    150
  • sponsor
    University of Alberta
Updated on 30 May 2022

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).

Details
Condition Prostate Cancer
Treatment PSMA-1007 Positron Emission Tomography (PET) scan and 3T Magnetic Resonance Imaging (MRI)
Clinical Study IdentifierNCT05141760
SponsorUniversity of Alberta
Last Modified on30 May 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Patients or their legal medical decision makers will sign an informed consent prior to entering the study
Adult patient (≥ 18 years old) with a diagnosis of at least Gleason Grade Group 2 prostate cancer
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

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