Prostate Cancer
Conditions
Brief 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 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).
Interventions
DIAGNOSTIC_TESTPSMA-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
Sponsors
Canadian Urological Association Scholarship Foundation
University of Alberta
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patients or their legal medical decision makers will sign an informed consent prior to entering the study. 2. Adult patient (≥ 18 years old) with a diagnosis of at least Gleason Grade Group 2 prostate cancer. 3. 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
1. Unable to obtain consent 2. Weight \>250 kg (weight limitation of scanners) 3. Unable to lie flat for 30 minutes to complete the PET or MRI imaging 4. Severe claustrophobia precluding image acquisition 5. Lack of intravenous access 6. Non-MRI compatible pacemaker or hardware 7. eGFR \< 40 mL/min/1.73 m2 and/or a history of a severe reaction to MRI contrast 8. Prior androgen deprivation therapy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Tumor T-staging | Through study completion, this is expected to be reviewed within 1 year of imaging | Differentiate Unilateral vs. Bilateral Tumor (i.e. T2a vs. T2b), Identify extracapsular extension (T3a) or Seminal vesicle invasion (T3b) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Sensitivity of MRI | Through study completion, this is expected to be reviewed within 1 year of imaging | Compare final histology against MR imaging |
| Specificity of PSMA-1007 PET | Through study completion, this is expected to be reviewed within 1 year of imaging | Compare final histology against PSMA-1007 PET |
| Specificity of MRI | Through study completion, this is expected to be reviewed within 1 year of imaging | Compare final histology against MR imaging |
| Negative Predictive Value of PSMA-1007 PET | Through study completion, this is expected to be reviewed within 1 year of imaging | Compare final histology against PSMA-1007 PET |
| Negative Predictive Value of MRI | Through study completion, this is expected to be reviewed within 1 year of imaging | Compare final histology against MR imaging |
| Positive Predictive Value of PSMA-1007 PET | Through study completion, this is expected to be reviewed within 1 year of imaging | Compare final histology against PSMA-1007 PET |
| Sensitivity of PSMA-1007 PET | Through study completion, this is expected to be reviewed within 1 year of imaging | Compare final histology against PSMA-1007 PET |
| Nodal Staging | Through study completion, this is expected to be reviewed within 1 year of imaging | Accuracy of nodal disease on PSMA-1007 PET and MRI compared to bone scan + CT |
| Metastatic Staging | Through study completion, this is expected to be reviewed within 1 year of imaging | Accuracy of PSMA-1007 PET and MRI compared to bone scan + CT |
| Longest Tumor diameter | Through study completion, this is expected to be reviewed within 1 year of imaging | Compare final histology against PSMA-1007 PET and MRI measurements |
| Identification of dominant lesion | Through study completion, this is expected to be reviewed within 1 year of imaging | Compare rate of dominant lesion identification of PSMA-1007 PET and MRI against final histology |
| Identification of non-dominant lesion | Through study completion, this is expected to be reviewed within 1 year of imaging | Compare rate of non-dominant lesion identification of PSMA-1007 PET and MRI against final histology |
| Positive Predictive Value of MRI | Through study completion, this is expected to be reviewed within 1 year of imaging | Compare final histology against MRI |
Countries
Canada
Outcome results
None listed