18F-PSMA PET and MRI in the Primary Staging of Prostate Cancer Patients
- Conditions
- Prostate Cancer
- Registration Number
- NCT05141760
- Lead Sponsor
- University of Alberta
- 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 150
- 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)
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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
Sensitivity of MRI Through study completion, this is expected to be reviewed within 1 year of imaging Compare final histology against MR imaging
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
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
Specificity 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
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
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 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
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
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 MRI Through study completion, this is expected to be reviewed within 1 year of imaging Compare final histology against MRI
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
Trial Locations
- Locations (1)
University of Alberta
🇨🇦Edmonton, Alberta, Canada