Multi-modality Imaging (PCa) Using Sodium MRI and PSMA PET in Men Pre-prostatectomy

Summary

The study is a non-randomized, prospective trial of men scheduled for radical prostatectomy for treatment of prostate cancer as standard of care and will undergo a series of pre-operative multi-modality imaging studies. Pre-operative imaging will be correlated with actual pathology results and statistical modeling performed to determine the most informative imaging biomarkers in predicting cancer location and aggressiveness (Gleason Score).

Conditions

• Prostate Cancer
• Prostate Adenocarcinoma
• Prostate Neoplasm

Interventions

DIAGNOSTIC_TEST

PET Scan

PET imaging uses small amounts of a radioactive substance called a tracer to look for disease in the body. The radioactive substance used in this study is \[18F\]PSMA-1007.

DRUG

[18F]PSMA-1007 Injection

\[18F\]PSMA-1007 is given by intravenous (IV) injection into the arm. It travels through the blood stream where it is rapidly taken up by prostate cancer cells and emits tiny, positively charged particles (called positrons) that produce signals into the body. These signals are detected by the PET component of the PET/MRI scanner.

DIAGNOSTIC_TEST

Sodium MRI

Sodium MRI uses magnetic waves and a specially-designed rectal probe to measure the sodium concentration (amount of salt) in the prostate. Previous research has shown that higher sodium concentrations in the prostate might be a sign of more aggressive cancer.

DIAGNOSTIC_TEST

Multiparametric MRI

MRI is a common medical diagnostic tool that uses magnetic waves and a contrast agent (dye) called Gadovist to take pictures of body tissue.

Sponsors & Collaborators

• Western University, Canada

  collaborator OTHER

• United States Department of Defense

  collaborator FED

• Centre for Probe Development and Commercialization

  collaborator OTHER

• Glenn Bauman

  lead OTHER

Principal Investigators

• Stephen Pautler, MD, FRCSC · London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Study Design

Allocation

NA

Purpose

DIAGNOSTIC

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

MALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-02-04

Primary Completion

2024-01-23

Completion

2025-09-30

Countries

• Canada

Study Locations