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Sodium MRI + PSMA PET for Prostate Cancer (IGPC-5 Trial)

Phase 2
Recruiting
Led By Stephen Pautler, MD, FRCSC
Research Sponsored by Glenn Bauman
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 years
Awards & highlights

IGPC-5 Trial Summary

This trial will help determine which imaging methods are most effective in predicting the location and aggressiveness of prostate cancer.

Who is the study for?
Men aged 18+ with confirmed prostate cancer who are planning to have their prostates surgically removed. They must be able to undergo multiple pre-surgery imaging tests and not have severe kidney disease, metal in the eye area, recent use of certain medications for urinary issues, or any condition that makes MRI unsafe.Check my eligibility
What is being tested?
The trial is testing a combination of advanced imaging techniques (Multiparametric MRI, Sodium MRI, and PET scans using [18F]PSMA-1007) before prostate removal surgery. The goal is to see how well these images predict the exact location and severity of the cancer compared to actual surgical findings.See study design
What are the potential side effects?
Potential side effects may include allergic reactions to contrast agents used during imaging procedures. There's also a risk of discomfort or complications from lying still during long scans and exposure to radiation from PET scans.

IGPC-5 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Pathologic Validation and Modeling

IGPC-5 Trial Design

1Treatment groups
Experimental Treatment
Group I: Multi-modality prostate cancer imagingExperimental Treatment4 Interventions
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).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Multiparametric MRI
2013
N/A
~110
PET Scan
2006
Completed Phase 3
~590

Find a Location

Who is running the clinical trial?

University of Western Ontario, CanadaOTHER
164 Previous Clinical Trials
319,201 Total Patients Enrolled
Western University, CanadaOTHER
239 Previous Clinical Trials
56,876 Total Patients Enrolled
Centre for Probe Development and CommercializationOTHER
6 Previous Clinical Trials
3,268 Total Patients Enrolled

Media Library

Multiparametric MRI Clinical Trial Eligibility Overview. Trial Name: NCT04053842 — Phase 2
Prostate Adenocarcinoma Research Study Groups: Multi-modality prostate cancer imaging
Prostate Adenocarcinoma Clinical Trial 2023: Multiparametric MRI Highlights & Side Effects. Trial Name: NCT04053842 — Phase 2
Multiparametric MRI 2023 Treatment Timeline for Medical Study. Trial Name: NCT04053842 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
New England Journal of MedicineJournal
10-year Outcomes After Monitoring, Surgery, or Radiotherapy for Localized Prostate Cancer
Hamdy, Freddie C., Jenny L. Donovan, J. Athene Lane, Malcolm Mason, Chris Metcalfe, Peter Holding, Michael Davis, et al.. 2016. “10-year Outcomes After Monitoring, Surgery, or Radiotherapy for Localized Prostate Cancer”. New England Journal of Medicine. Massachusetts Medical Society. doi:10.1056/nejmoa1606220.
UrologyJournal
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
Makarov, Danil V., Bruce J. Trock, Elizabeth B. Humphreys, Leslie A. Mangold, Patrick C. Walsh, Jonathan I. Epstein, and Alan W. Partin. 2007. “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. Elsevier BV. doi:10.1016/j.urology.2007.03.042.
European RadiologyJournal
ESUR Prostate MR Guidelines 2012
Barentsz, Jelle O., Jonathan Richenberg, Richard Clements, Peter Choyke, Sadhna Verma, Geert Villeirs, Olivier Rouviere, Vibeke Logager, and Jurgen J. Fütterer. 2012. “ESUR Prostate MR Guidelines 2012”. European Radiology. Springer Science and Business Media LLC. doi:10.1007/s00330-011-2377-y.
RadiologyJournal
Prostate Cancer: Multiparametric MR Imaging for Detection, Localization, and Staging
Hoeks, Caroline M. A., Jelle O. Barentsz, Thomas Hambrock, Derya Yakar, Diederik M. Somford, Stijn W. T. P. J. Heijmink, Tom W. J. Scheenen, et al.. 2011. “Prostate Cancer: Multiparametric MR Imaging for Detection, Localization, and Staging”. Radiology. Radiological Society of North America (RSNA). doi:10.1148/radiol.11091822.
All > Canada Prostate Cancer
~3 spots leftby Jul 2024
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