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Prostate CancerPhase 2IGPC-5NCT04053842

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

A Phase 2 study testing PET Scan, [18F]PSMA-1007 Injection and Sodium MRI in people with Prostate Cancer and Prostate Adenocarcinoma, run by Glenn Bauman at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, men only
What is being tested?
PET Scan, [18F]PSMA-1007 Injection and Sodium MRI
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
16 participants
Where
1 siteCanada
Study dates
4 Feb 2021to 24 Jun 2025
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 12Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • London Health Sciences Centre

    London, Ontario, N6A 5W9

Other trials in Canada

About this study

Official title: Multi-modality Prostate Cancer Image Guided Interventions - 5

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).

Read the detailed description

The over-arching goal is to "improve the quality of life for survivors of prostate cancer" through advanced imaging tools for improved pre-treatment detection and characterization of prostate cancer through non-invasive imaging.

Seminal research measuring tissue sodium concentration (TSC) in human PCa with sodium MRI has demonstrated increased TSC in prostate lesions related to tumor aggressiveness. This suggests that the addition of sodium MRI to mpMRI data will enhance the identification and characterization of prostate lesions in men with PCa. This will improve the healthcare of men through better risk stratification and treatment decisions, which will ultimately reduce overtreatment. Radio-labeled PET tracers that target PSMA have demonstrated exceptional sensitivity for molecular imaging of prostate lesions. Lesion-detection specificity of combined PSMA PET and mpMRI is very high (97 - 100%). However, PSMA PET is not practical for active surveillance of prostate cancer within the current healthcare system due to limited access and the fact that its added cost and radiation dose restricts its utility for repeated scans. However, as a tool to develop and validate our imaging assay, it is unparalleled. Compared with hybrid PET/MRI, a single modality imaging assay based only on mpMRI contrasts and endogenous TSC would be more widely available, cost effective and find wider clinical adoption - particularly for AS. The immediate expected outcome from this project is that an MRI assay combining data from mpMRI and sodium MRI will have a similar ability as PSMA PET to accurately discriminate between low- and high-risk PCa for improved treatment decisions and surveillance of low-risk disease.

The transformative potential of a non-invasive, single modality, whole-gland imaging assay comprised of biomarkers from combined TSC and mpMRI could ultimately replace serial biopsies for surveillance of men with low- and intermediate-risk disease. Patients who are educated to understand the typical slow progression of low-risk PCa, surveillance methods and treatment risks are more likely to consider AS. In a systematic approach developed to improve physician counselling of low-risk PCa patients, the acceptance rate for AS was improved to 94% - a relative reduction of approximately 30% in the risk of unnecessary curative treatment. However, it is also important to note that the rate of subsequent treatment for men undergoing AS may be as high as 50% over 10 years of follow-up. The majority of these men are transitioned to treatment within 2-3 years of initial diagnosis. Identification of those men who fit the criteria for AS but are destined to have early progression is an important clinical goal. Those men can be streamed to early treatment through longitudinal assessment of lesion progression with this imaging assay and thus increase the confidence and uptake of AS protocols. AS of PCa (including possible delayed treatment) saves costs over the lifetime of a patient, compared with immediate treatment and provides superior quality of life.

Research Strategy: The investigators will evaluate a non-invasive imaging assay for in vivo characterization of prostate lesions comprised of clinical multi-parametric magnetic resonance imaging (mpMRI) combined with sodium magnetic resonance imaging (sodium MRI) in a cohort of men with biopsy-proven prostate cancer. The use of mpMRI to detect, localize and stage prostate cancer is becoming standard clinical practice. Prior research in ten patients has established that tissue sodium concentration (TSC) assessed by sodium MRI increases significantly with histological grade in prostate lesions. The addition of TSC data to conventional mpMRI data (i.e. ADC values, T2 contrast, contrast agent wash-in/out rates) will be evaluated in a multivariate data analysis to demonstrate that a combination of these imaging protocols improves the characterization of PCa. The resulting predictive tool (imaging assay) will accurately discriminate between low- and high-risk PCa for improved treatment decisions and to assess possible progression of low-risk disease during surveillance.

This imaging assay will be validated against positron emission tomography (PET) using a radio-labeled tracer which binds to prostate-specific membrane antigen (PSMA). PSMA PET is arguably the most sensitive imaging method for detection of intra-prostatic lesions. Importantly, it has a high sensitivity for prostate lesion detection (>90%), even for lower tumor grades where mpMRI has difficulties. Maximum standard uptake value (SUVmax) of this radiotracer has been positively correlated with Gleason grade and as such, is an excellent comparator for TSC assessment of lesion aggressiveness. Unfortunately, the limited accessibility and cost of PET hinders its clinical application.

In this project, the investigators expect to validate that the addition of sodium MRI to mpMRI can provide similar lesion characterization compared to PSMA PET. Data supporting this hypothesis will be acquired using a hybrid PET/MRI system because this is the best imaging platform for this project. If successful, the incorporation of sodium MRI into existing mpMRI protocols would improve characterization of disease and be a more cost effective and generalizable innovation compared to PET-based techniques that require both an expensive probe as well as hybrid imaging platforms.

Being tested
PET Scan, [18F]PSMA-1007 Injection, Sodium MRI, Multiparametric MRI
Keywords
Prostate Cancer, PSMA PET, [18F]PSMA-1007 PET/CT imaging, Radical Prostatectomy, Sodium MRI, Sodium Imaging
Medical subject headings
Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PET ScanDiagnostic test

    Also called PSMA PET

    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.

  • [18F]PSMA-1007 InjectionDrug

    Also called PSMA

    [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.

  • Sodium MRIDiagnostic 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.

  • Multiparametric MRIDiagnostic test

    Also called mpMRI

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

Study groups in NCT04053842
Study groupRoleWhat they receive
Multi-modality prostate cancer imagingExperimentalThe 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).
Receives: Diagnostic Test: PET Scan; Drug: [18F]PSMA-1007 Injection; Diagnostic Test: Sodium MRI; Diagnostic Test: Multiparametric MRI

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 4 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Aug 2019
  2. Study start4 Feb 2021
  3. Primary completion1 Sep 2024
  4. Study completion24 Jun 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Diagnosis
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
16 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04053842
Sponsor's protocol ID
IGPC-5
Other IDs
REB File # 114138
Acronym
IGPC-5
Status last verified
Sep 2026
First submitted
8 Aug 2019
Last updated
18 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Chun FK, Karakiewicz PI, Briganti A, Walz J, Kattan MW, Huland H, Graefen M. A critical appraisal of logistic regression-based nomograms, artificial neural networks, classification and regression-tree models, look-up tables and risk-group stratification models for prostate cancer. BJU Int. 2007 Apr;99(4):794-800. doi: 10.1111/j.1464-410X.2006.06694.x.

    PubMed 17378842

  • Makarov DV, Trock BJ, Humphreys EB, Mangold LA, Walsh PC, Epstein JI, Partin AW. Updated nomogram to predict pathologic stage of prostate cancer given prostate-specific antigen level, clinical stage, and biopsy Gleason score (Partin tables) based on cases from 2000 to 2005. Urology. 2007 Jun;69(6):1095-101. doi: 10.1016/j.urology.2007.03.042.

    PubMed 17572194

  • Hricak H, Choyke PL, Eberhardt SC, Leibel SA, Scardino PT. Imaging prostate cancer: a multidisciplinary perspective. Radiology. 2007 Apr;243(1):28-53. doi: 10.1148/radiol.2431030580.

    PubMed 17392247

  • Chan I, Wells W 3rd, Mulkern RV, Haker S, Zhang J, Zou KH, Maier SE, Tempany CM. Detection of prostate cancer by integration of line-scan diffusion, T2-mapping and T2-weighted magnetic resonance imaging; a multichannel statistical classifier. Med Phys. 2003 Sep;30(9):2390-8. doi: 10.1118/1.1593633.

    PubMed 14528961

  • Barrett T, Turkbey B, Choyke PL. PI-RADS version 2: what you need to know. Clin Radiol. 2015 Nov;70(11):1165-76. doi: 10.1016/j.crad.2015.06.093. Epub 2015 Jul 29.

    PubMed 26231470

  • Kwee SA, Thibault GP, Stack RS, Coel MN, Furusato B, Sesterhenn IA. Use of step-section histopathology to evaluate 18F-fluorocholine PET sextant localization of prostate cancer. Mol Imaging. 2008 Jan-Feb;7(1):12-20.

    PubMed 18384719

  • Ward AD, Crukley C, McKenzie CA, Montreuil J, Gibson E, Romagnoli C, Gomez JA, Moussa M, Chin J, Bauman G, Fenster A. Prostate: registration of digital histopathologic images to in vivo MR images acquired by using endorectal receive coil. Radiology. 2012 Jun;263(3):856-64. doi: 10.1148/radiol.12102294. Epub 2012 Apr 2.

    PubMed 22474671

  • Han W, Johnson C, Gaed M, Gomez JA, Moussa M, Chin JL, et al. Automatic cancer detection and localization on prostatectomy histopathology images. In: Tomaszewski JE, Gurcan MN, editors. Medical Imaging 2018: Digital Pathology. Proceedings of SPIE. 10581. Bellingham: Spie-Int Soc Optical Engineering; 2018

  • Alfano R, Soetemans D, Bauman GS, Gibson E, Gaed M, Moussa M, et al. Development of a Computer Aided Diagnosis Model for Prostate Cancer Classification on Multi-Parametric MRI. In: Petrick N, Mori K, editors. Medical Imaging 2018: Computer-Aided Diagnosis. Proceedings of SPIE. 10575. Bellingham: Spie-Int Soc Optical Engineering; 2018.

  • Evans JD, Jethwa KR, Ost P, Williams S, Kwon ED, Lowe VJ, Davis BJ. Prostate cancer-specific PET radiotracers: A review on the clinical utility in recurrent disease. Pract Radiat Oncol. 2018 Jan-Feb;8(1):28-39. doi: 10.1016/j.prro.2017.07.011. Epub 2017 Jul 20.

    PubMed 29037965

  • Broeke NC, Peterson J, Lee J, Martin PR, Farag A, Gomez JA, Moussa M, Gaed M, Chin J, Pautler SE, Ward A, Bauman G, Bartha R, Scholl TJ. Characterization of clinical human prostate cancer lesions using 3.0-T sodium MRI registered to Gleason-graded whole-mount histopathology. J Magn Reson Imaging. 2019 May;49(5):1409-1419. doi: 10.1002/jmri.26336. Epub 2018 Nov 14.

    PubMed 30430700

  • Bauman G, Martin P, Thiessen JD, Taylor R, Moussa M, Gaed M, Rachinsky I, Kassam Z, Chin J, Pautler S, Lee TY, Valliant JF, Ward A. [18F]-DCFPyL Positron Emission Tomography/Magnetic Resonance Imaging for Localization of Dominant Intraprostatic Foci: First Experience. Eur Urol Focus. 2018 Sep;4(5):702-706. doi: 10.1016/j.euf.2016.10.002. Epub 2016 Oct 26.

    PubMed 28753797

  • Uprimny C, Kroiss AS, Decristoforo C, Fritz J, von Guggenberg E, Kendler D, Scarpa L, di Santo G, Roig LG, Maffey-Steffan J, Horninger W, Virgolini IJ. 68Ga-PSMA-11 PET/CT in primary staging of prostate cancer: PSA and Gleason score predict the intensity of tracer accumulation in the primary tumour. Eur J Nucl Med Mol Imaging. 2017 Jun;44(6):941-949. doi: 10.1007/s00259-017-3631-6. Epub 2017 Jan 31.

    PubMed 28138747

  • Barrett T, Riemer F, McLean MA, Kaggie J, Robb F, Tropp JS, Warren A, Bratt O, Shah N, Gnanapragasam VJ, Gilbert FJ, Graves MJ, Gallagher FA. Quantification of Total and Intracellular Sodium Concentration in Primary Prostate Cancer and Adjacent Normal Prostate Tissue With Magnetic Resonance Imaging. Invest Radiol. 2018 Aug;53(8):450-456. doi: 10.1097/RLI.0000000000000470.

    PubMed 29969108

  • Kozlowski P, Chang SD, Meng R, Madler B, Bell R, Jones EC, Goldenberg SL. Combined prostate diffusion tensor imaging and dynamic contrast enhanced MRI at 3T--quantitative correlation with biopsy. Magn Reson Imaging. 2010 Jun;28(5):621-8. doi: 10.1016/j.mri.2010.03.011. Epub 2010 Apr 13.

    PubMed 20392586

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing PET Scan, [18F]PSMA-1007 Injection and Sodium MRI in people with Prostate Cancer and Prostate Adenocarcinoma, run by Glenn Bauman at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pathologic Validation and Modeling (time frame: 4 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04053842, which also lists 28 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2026.

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