Multi-modality Prostate Cancer Image Guided Interventions (IGPC-2)

February 26, 2024 updated by: Lawson Health Research Institute
This is a non-randomized, prospective trial of men who are scheduled for radical prostatectomy for treatment of prostate cancer, or repeat biopsy for localized prostate cancer as standard of care and who will undergo a series of pre-operative multi-modality imaging studies. Post intervention, hybrid imaging maps (HIM) will be generated and the predictions of the HIM (3D location, volume and grade of cancer) will be correlated with actual pathology results to gauge the performance of the HIM in both radical prostatectomy and biopsy settings.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This study was built on our first study (IGPC-1, REB number 15551) which acquired multi-modality imaging in 36 patients undergoing radical prostatectomy. We successfully demonstrated the ability to accurately co-register pre-operative multi-modality images (MRI: T1, T2, Diffusion Weighed (DW), Dynamic Contrast enhanced (DCE); Dynamic Contrast Enhanced CT, 3D Ultrasound with post-operative whole mount pathology specimens. We have developed a platform for the segmentation of prostate cancer on the whole mount pathology specimens and are in the process of analyzing the data to develop a hybrid imaging map (HIM) of prostate cancer distribution (location and grade) based on the correlation of the pre-operative imaging signals and the post-operative pathology (citation provided below). The HIM will need subsequent validation in a separate cohort of radical prostatectomy patients and evaluated as to its ability to be incorporated as a targeting tool for prostate interventions such as prostate biopsy and this is the purpose of this follow-up study.

On the IGPC-2 study, pre-operative imaging panels were successfully obtained in 24 patients accrued to cohort 1. The protocol was then amended to include [18-F]-DCFPyl instead of [18F]-FCH. [18-F]-DCFPyl was a newer PET probe that may possess superior performance because it is directed against prostate specific membrane antigen (PSMA), a protein commonly expressed on prostate cancer cells. Imaging-pathology correlations in the first 6 patients imaged with [18-F]-DCFPyl were compared to the correlations obtained with [18F]-FCH imaging in the first 24 patients.

IGPC-2 Cohort 1 (Radical Prostatectomy) was expanded to provide an additional 20 men imaged with [18-F]-DCFPyl as part of the imaging panel. The goal was to acquire 24 complete imaging datasets with [18-F]-DCFPyl as the PET imaging agent to enable us to draw comparisons with the 24 [18F]-FCH imaging data sets acquired.

Study Type

Interventional

Enrollment (Actual)

52

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • London, Ontario, Canada, N6A 5W9
        • London Health Sciences Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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, or repeat biopsy as standard of care

Exclusion Criteria:

  • Prior therapy for prostate cancer (including hormone therapy), with the exception of radiation therapy for Cohort 2 only
  • 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 dimensions for whole mount pathology slides
  • Allergy to contrast agents to be used as part of the imaging panel
  • Sickle cell disease or other anemias
  • Insufficient renal function (eGFR < 60 mL/min/1.73 m2)
  • Residual bladder volume > 150 cc (determined by post-void ultrasound)
  • Hip prosthesis, vascular grafting that is MRI incompatible or sources of artifact within the pelvis

  • Contraindication to MRI

    • pacemaker or other electronic implants
    • known metal in the orbit
    • cerebral aneurysm clips

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Imaging Panel
Patients who provided written informed consent and found to be eligible for study were asked to complete Positron Emission Tomography (PET) + Dynamic CT imaging, PET/MRI (with endorectal coil) and 3D-Transrectal ultrasound prior to standard of care radical prostatectomy.
Other: Imaging Panel

Initial Protocol (REB approval date 08-Sept-2011)

Pre-operative Imaging Panel

  • [18F]-FCH PET + Dynamic CT
  • MRI of the pelvis with endorectal coil (T1, T2, DW, DCE, MRS)
  • 3D-Transrectal ultrasound
  • Optional PET/MRI (added with Protocol Amend 1, REB approval date 22-Aug-2012)
  • Optional Sodium (23Na) MRI (added with Protocol Amend 2, REB approval date 25-Feb-2013)

Protocol Amendment #3, REB approval date 20-Oct-2015:

Pre-operative Imaging Panel

  • [18-F]-DCFPyL PET+Dynamic CT
  • PET/MRI with endorectal coil
  • 3D-Transrectal Ultrasound
  • Optional Sodium (23Na) MRI

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hybrid Imaging Map (HIM) Validation
Time Frame: Within two years of study completion.
We will determine if individualized hybrid imaging maps (HIMs) based on a pre-operative imaging panel accurately predicts the actual cancer distribution found in the whole mount prostatectomy specimens obtained from the surgery.
Within two years of study completion.

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
MRI Prostate Sodium Imaging Validation
Time Frame: Within two years of study completion
We will determine if sodium levels in the prostate based on a pre-operative sodium MRI accurately predicts the actual cancer distribution found in the whole mount prostatectomy specimens obtained from the surgery.
Within two years of study completion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lawson Health Research Institute

Collaborators

Canadian Institutes of Health Research (CIHR)

Investigators

  • Principal Investigator: Dr. Glenn Bauman, MD, Lawson Health Research Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 12, 2012

Primary Completion (Actual)

June 30, 2018

Study Completion (Actual)

June 21, 2023

Study Registration Dates

First Submitted

October 24, 2018

First Submitted That Met QC Criteria

July 3, 2019

First Posted (Actual)

July 5, 2019

Study Record Updates

Last Update Posted (Actual)

February 28, 2024

Last Update Submitted That Met QC Criteria

February 26, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 101038

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Fully anonymized study data such as de-identified images, digital pathology slides, prostate tissue slides and prostate cancer diagnosis information can be available for data analysis.

IPD Sharing Access Criteria

Institutionally approved material sharing agreement.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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