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

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 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

• 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