NCT05141760

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 150 (actual)
• Sponsor: University of Alberta · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
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

Timeline

• Start date: 2022-02-10
• Primary completion: 2023-06-15
• Completion: 2023-06-15
• First posted: 2021-12-02
• Last updated: 2024-06-06

Locations

1 site across 1 country: Canada