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

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

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).

Study Overview

• Status: Active, not recruiting
• Conditions: Prostate Cancer
• Intervention / Treatment: Diagnostic test: PSMA-1007 Positron Emission Tomography (PET) scan and 3T Magnetic Resonance Imaging (MRI)

• Study Type: Interventional
• Enrollment (Estimated): 150
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Alexander Tamm, MD, FRCPC; Phone Number: 780-407-6907; Email: astamm@ualberta.ca
• Study Contact Backup: Name: Adam Kinnaird, MD, PhD, FRCSC; Phone Number: 321 780-407-5800; Email: ask@ualberta.ca

Study Locations

• Canada
  • Alberta
    • Edmonton, Alberta, Canada, T6G 2B7
      • University of Alberta

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Alberta
• Collaborators: Canadian Urological Association Scholarship Foundation

Study record dates

Study Major Dates

• Study Start (Actual): February 10, 2022
• Primary Completion (Estimated): July 31, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: November 9, 2021
• First Submitted That Met QC Criteria: November 18, 2021
• First Posted (Actual): December 2, 2021

Study Record Updates

• Last Update Posted (Actual): June 1, 2023
• Last Update Submitted That Met QC Criteria: May 30, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Urogenital Diseases; Male Urogenital Diseases; Genital Diseases, Male; Genital Diseases; Prostatic Neoplasms
• Other Study ID Numbers: HREBA.CC-21-0073

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No