Clinical trial NCT05141760: 18F-PSMA PET and MRI in the Primary Staging of Prostate Cancer Patients
Official title: Assessing 18F-PSMA-1007 Positron Emission Tomography and Magnetic Resonance Imaging in the Primary Staging of Prostate Cancer Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Prostate Cancer
Lead sponsor: University of Alberta
Sponsor class: OTHER
Collaborators: name: Canadian Urological Association Scholarship Foundation
First posted: 2021-12-02
Enrollment: 150
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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).


Eligibility criteria: 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

Primary outcomes:
measure: Tumor T-staging
timeFrame: Through study completion, this is expected to be reviewed within 1 year of imaging
Secondary outcomes:
measure: Sensitivity of PSMA-1007 PET
timeFrame: Through study completion, this is expected to be reviewed within 1 year of imaging
measure: Sensitivity of MRI
timeFrame: Through study completion, this is expected to be reviewed within 1 year of imaging
measure: Specificity of PSMA-1007 PET
timeFrame: Through study completion, this is expected to be reviewed within 1 year of imaging
measure: Specificity of MRI
timeFrame: Through study completion, this is expected to be reviewed within 1 year of imaging
measure: Negative Predictive Value of PSMA-1007 PET
timeFrame: Through study completion, this is expected to be reviewed within 1 year of imaging
measure: Negative Predictive Value of MRI
timeFrame: Through study completion, this is expected to be reviewed within 1 year of imaging
measure: Positive Predictive Value of PSMA-1007 PET
timeFrame: Through study completion, this is expected to be reviewed within 1 year of imaging
measure: Positive Predictive Value of MRI
timeFrame: Through study completion, this is expected to be reviewed within 1 year of imaging
measure: Nodal Staging
timeFrame: Through study completion, this is expected to be reviewed within 1 year of imaging
measure: Metastatic Staging
timeFrame: Through study completion, this is expected to be reviewed within 1 year of imaging
measure: Longest Tumor diameter
timeFrame: Through study completion, this is expected to be reviewed within 1 year of imaging
measure: Identification of dominant lesion
timeFrame: Through study completion, this is expected to be reviewed within 1 year of imaging
measure: Identification of non-dominant lesion
timeFrame: Through study completion, this is expected to be reviewed within 1 year of imaging
Other outcomes:
Locations:
city: Edmonton
country: Canada
facility: University of Alberta
state: Alberta
Study officials:
References: