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| Name | Class |
|---|---|
| Canadian Urological Association Scholarship Foundation | UNKNOWN |
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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).
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PSMA-1007 Positron Emission Tomography (PET) scan and 3T Magnetic Resonance Imaging (MRI) | Diagnostic Test | Additional staging PET and MRI scan prior to prostatectomy and lymph node dissection |
| Measure | Description | Time Frame |
|---|---|---|
| Tumor T-staging | Differentiate Unilateral vs. Bilateral Tumor (i.e. T2a vs. T2b), Identify extracapsular extension (T3a) or Seminal vesicle invasion (T3b) | Through study completion, this is expected to be reviewed within 1 year of imaging |
| Measure | Description | Time Frame |
|---|---|---|
| Sensitivity of PSMA-1007 PET | Compare final histology against PSMA-1007 PET | Through study completion, this is expected to be reviewed within 1 year of imaging |
| Sensitivity of MRI | Compare final histology against MR imaging |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alberta | Edmonton | Alberta | T6G 2B7 | Canada |
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D011877 | Radionuclide Imaging |
| ID | Term |
|---|---|
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D003947 | Diagnostic Techniques, Radioisotope |
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| 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 | Through study completion, this is expected to be reviewed within 1 year of imaging |
| Specificity of MRI | Compare final histology against MR imaging | 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 | 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 | 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 | Through study completion, this is expected to be reviewed within 1 year of imaging |
| Positive Predictive Value of MRI | Compare final histology against MRI | 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 | 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 | 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 | 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 | 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 | Through study completion, this is expected to be reviewed within 1 year of imaging |
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |