Clinical Trial · NCT05141760

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

Overview

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).

Sponsor

University of Alberta

Phase

Phase 2

ClinicalTrials.gov

NCT05141760

Drug / Compound

PSMA-1007

Isotope(s):

Target(s):

PSMA

Ligand Class: Small Molecules

Linker: 6-fluoronicotinic acid prosthetic group

Eligibility

Inclusion

Appropriate staging investigations have been performed prior to the participation in the study (i.e. CT abdomen/pelvis and 99mTc-MDP bone scan)

Exclusion

Non-MRI compatible pacemaker or hardware
eGFR \< 40 mL/min/1.73 m2 and/or a history of a severe reaction to MRI contrast
Weight \>250 kg (weight limitation of scanners)
Unable to lie flat for 30 minutes to complete the PET or MRI imaging
Prior androgen deprivation therapy
Severe claustrophobia precluding image acquisition
Unable to obtain consent
Lack of intravenous access