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).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
150
Additional staging PET and MRI scan prior to prostatectomy and lymph node dissection
University of Alberta
Edmonton, Alberta, Canada
Tumor T-staging
Differentiate Unilateral vs. Bilateral Tumor (i.e. T2a vs. T2b), Identify extracapsular extension (T3a) or Seminal vesicle invasion (T3b)
Time frame: Through study completion, this is expected to be reviewed within 1 year of imaging
Sensitivity of PSMA-1007 PET
Compare final histology against PSMA-1007 PET
Time frame: Through study completion, this is expected to be reviewed within 1 year of imaging
Sensitivity of MRI
Compare final histology against MR imaging
Time frame: Through study completion, this is expected to be reviewed within 1 year of imaging
Specificity of PSMA-1007 PET
Compare final histology against PSMA-1007 PET
Time frame: Through study completion, this is expected to be reviewed within 1 year of imaging
Specificity of MRI
Compare final histology against MR imaging
Time frame: Through study completion, this is expected to be reviewed within 1 year of imaging
Negative Predictive Value of PSMA-1007 PET
Compare final histology against PSMA-1007 PET
Time frame: Through study completion, this is expected to be reviewed within 1 year of imaging
Negative Predictive Value of MRI
Compare final histology against MR imaging
Time frame: Through study completion, this is expected to be reviewed within 1 year of imaging
Positive Predictive Value of PSMA-1007 PET
Compare final histology against PSMA-1007 PET
Time frame: Through study completion, this is expected to be reviewed within 1 year of imaging
Positive Predictive Value of MRI
Compare final histology against MRI
Time frame: Through study completion, this is expected to be reviewed within 1 year of imaging
Nodal Staging
Accuracy of nodal disease on PSMA-1007 PET and MRI compared to bone scan + CT
Time frame: Through study completion, this is expected to be reviewed within 1 year of imaging
Metastatic Staging
Accuracy of PSMA-1007 PET and MRI compared to bone scan + CT
Time frame: Through study completion, this is expected to be reviewed within 1 year of imaging
Longest Tumor diameter
Compare final histology against PSMA-1007 PET and MRI measurements
Time frame: Through study completion, this is expected to be reviewed within 1 year of imaging
Identification of dominant lesion
Compare rate of dominant lesion identification of PSMA-1007 PET and MRI against final histology
Time frame: Through study completion, this is expected to be reviewed within 1 year of imaging
Identification of non-dominant lesion
Compare rate of non-dominant lesion identification of PSMA-1007 PET and MRI against final histology
Time frame: Through study completion, this is expected to be reviewed within 1 year of imaging
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