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

NCT04053842 | Active Not Recruiting Phase 2

• 2 other identifiers: IGPC-5REB File # 114138
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Prostate Cancer; PSMA PET; [18F]PSMA-1007 PET/CT imaging; Radical Prostatectomy; Sodium MRI; Sodium Imaging

Outcome Measures

Primary Outcomes (1)

• Pathologic Validation and Modeling

  We will evaluate the ability of simultaneous multiparametric MRI (mpMRI), sodium MRI and positron emission tomography (PET) with a radio-labeled probe for prostate-specific membrane antigen (PSMA) to accurately predict the actual cancer distribution found in the whole mount prostatectomy specimens obtained from the surgery. A variety of statistical methods will be utilized to build predictive models based on the extracted features and to identify a final model that will be used as the predictive tool (i.e. the imaging assay). We will quantify the ability of these models to enhance clinical lesion identification.

  4 years

Study Arms (1)

Multi-modality prostate cancer imaging

EXPERIMENTAL

The study requires eligible patients to complete one imaging session at St. Joseph's Health Care to begin within 6 weeks of the scheduled Radical Prostatectomy. Imaging will consist of simultaneous multiparametric MRI (mpMRI), sodium MRI and positron emission tomography (PET) with a radio-labeled probe for prostate-specific membrane antigen (PSMA).

Diagnostic Test: PET Scan; Drug: [18F]PSMA-1007 Injection; Diagnostic Test: Sodium MRI; Diagnostic Test: Multiparametric MRI

Interventions

PET Scan DIAGNOSTIC_TEST

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.

Also known as: PSMA PET

Multi-modality prostate cancer imaging

[18F]PSMA-1007 Injection DRUG

\[18F\]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.

Also known as: PSMA

Multi-modality prostate cancer imaging

Sodium MRI DIAGNOSTIC_TEST

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.

Multi-modality prostate cancer imaging

Multiparametric MRI DIAGNOSTIC_TEST

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

Also known as: mpMRI

Multi-modality prostate cancer imaging

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Prostate cancer is a male disease.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Provision of informed consent for this study
• Male, aged 18 years or older
• Pathologically confirmed prostate cancer on previous biopsy
• Suitable for and consenting to Radical Prostatectomy for treatment as standard of care

You may not qualify if:

• Prior therapy for prostate cancer (including hormone therapy)
• Use of 5-alpha reductase inhibitors, i.e. finasteride (Proscar) or dutasteride (Avodart) within 6 months of study start. Patients undergoing a 6-month washout period prior to study start will be eligible.
• Inability to comply with the pre-operative imaging panel
• Patients scheduled for radical prostatectomy with prostate size exceeding 65 cc
• Allergy to contrast agents to be used as part of the imaging panel
• Acute kidney injury (AKI), chronic kidney disease (CKD) Stage 4 or 5 (estimated Glomerular Filtration Rate \[eGFR\] \< 30 mL/min/1.73m2) or those on dialysis
• Post-void residual urine volume \> 150 cc (determined by post-void ultrasound)
• Hip prosthesis, vascular grafting that is MRI incompatible or sources of artefact within the pelvis
• Contraindication to MRI
• pacemaker or other electronic implants
• known metal in the orbit
• cerebral aneurysm clips

Sponsors & Collaborators

• Glenn Bauman: lead
• Western University, Canada: collaborator
• United States Department of Defense: collaborator
• Centre for Probe Development and Commercialization: collaborator

Study Sites (1)

London Health Sciences Centre

London, Ontario, N6A 5W9, Canada

Location

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MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Positron-Emission Tomography; Multiparametric Magnetic Resonance Imaging

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Tomography, Emission-Computed; Image Interpretation, Computer-Assisted; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Image Enhancement; Photography; Radionuclide Imaging; Tomography; Diagnostic Techniques, Radioisotope; Magnetic Resonance Imaging

Study Officials

• Stephen Pautler, MD, FRCSC

  London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Overall Principal Investigator

Study Record Dates

• First Submitted: August 8, 2019
• First Posted: August 13, 2019
• Study Start: February 4, 2021
• Primary Completion: January 23, 2024
• Study Completion: September 1, 2025
• Last Updated: March 13, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)