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

Study Overview
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Brief Summary
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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).

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

Conditions
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Prostate Cancer

Intervention / Treatment
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* Diagnostic Test: PSMA-1007 Positron Emission Tomography (PET) scan and 3T Magnetic Resonance Imaging (MRI)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: PSMA-1007 Positron Emission Tomography (PET) scan and 3T Magnetic Resonance Imaging (MRI)|Additional staging PET and MRI scan prior to prostatectomy and lymph node dissection|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 |