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

Official Title

Assessing 18F-PSMA-1007 Positron Emission Tomography and Magnetic Resonance Imaging in the Primary Staging of Prostate Cancer Patients


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 multicentre 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).

Trial Description

Primary Outcome:

  • Tumour T-staging
Secondary Outcome:
  • Sensitivity of PSMA-1007 PET
  • Sensitivity of MRI
  • Specificity of PSMA-1007 PET
  • Specificity of MRI
  • Negative Predictive Value of PSMA-1007 PET
  • Negative Predictive Value of MRI
  • Positive Predictive Value of PSMA-1007 PET
  • Positive Predictive Value of MRI
  • Nodal Staging
  • Metastatic Staging
  • Longest Tumour diameter
  • Identification of dominant lesion
  • Identification of non-dominant lesion

View this trial on ClinicalTrials.gov

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Canadian Cancer Society

These resources are provided in partnership with the Canadian Cancer Society