Can MRI of the Prostate Combined With a Radiomics Evaluation Determine the Invasive Capacity of a Tumour (MRI-PREDICT)

August 19, 2024 updated by: Nova Scotia Health Authority

Can Magnetic Resonance Imaging of the Prostate Combined With a Radiomics Evaluation Determine the Invasive Capacity of a Tumour (Can MRI-PREDICT)

Prostate cancer is the most common cancer diagnosed in men in Canada. Magnetic resonance imaging (MRI) may become a valuable tool to non-invasively identify prostate cancer and assess its biological aggressiveness, which in turn will help doctors make better decisions about how to treat an individual patient's prostate cancer.

Despite the promise of MRI for detecting and characterizing prostate cancer, there are several recognized limitations and challenges. These include lack of standardized interpretation and reporting of prostate MRI exams.

The investigators propose to validate and improve a computer program computerized prediction tool that will use information from MR images to inform us how aggressive a prostate cancer is. The hypothesis is that this computer-aided approach will increase the reproducibility and accuracy of MRI in predicting the tumor biology information about the imaged prostate cancer.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Prostate biopsies are the gold standard assessment of how prostate cancer is diagnosed and how low risk prostate cancers are surveilled. The investigators have produced a machine-learning based algorithm which uses MRI characteristics (radiomic features or textures) to predict the results of a prostate biopsy. The field has numerous concerns that such radiomic based predictions will not be reproducible, as there as so many subtle changes between MRI scans of different patients.

The interventions are the use of the MRT and the use of a second MRI of the prostate (MRI-P).

Two primary outcomes will be investigated. First, the existing radiomics predictive model, labeled as the MRI-P based Radiomics Tool (MRT) will predict the Grade Group (GG) and compare it to the gold standard, pathologist's evaluation of the Grade Group (GG). Second, the stability of the predicted GG between two shortly spaced MRI-Ps will be compared.

Patients with a detectable prostate nodule on MRI-P which localizes to a biopsy confirmed prostate cancer will be approached for enrollment. If enrolled, participants will attend for a subsequent MRI-P in a brief time frame relative to the acquisition of the first MRI-P. Attempts will be made to obtain participants that allow for even distribution among all GGs.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

  • Name: Dr. Michael Kucharczyk
  • Phone Number: 9024736185

Study Locations

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

An appropriate diagnostic MRI-P, defined as:

  • Being performed on 3T MRI at the Halifax Infirmary Building
  • Taken place within 5 weeks of study enrolment
  • Having a detectable nodule which anatomically localizes to prostate cancer (PCa) identified in diagnostic biopsy specimen
  • Acquired T1+contrast, T2, and attenuated diffusion coefficient (ADC) series axial images of the prostate

An appropriate diagnostic biopsy, defined as:

  • Taken place within 2 months of the participant's MRI-P 1
  • Taken place within 3 months of participant's study enrolment
  • Reports diagnosis of PCa
  • Reports a systematic assessment of the biopsy, assessing at least 12 cores
  • Reports at least on core involved with PCa and this core must anatomically localise to a nodule seen on MRI-P 1

Exclusion Criteria:

  • Past prostatic interventions which would influence the prostate's structure
  • Alterations to physiological testosterone levels
  • Inability to position one's self in a reproducible fashion for an MRI-P
  • Patient factors reported to produce significant artifact on MRI-P 1

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Prospective Cohort
Sixty patients with a new diagnosis of prostate cancer that meet eligibility criteria. The group will have two standard MRI-P's completed. The first MRI-P will be acquired as standard of care and the second will be an additional investigation for the purposes of this study. The efficacy of the MRT will be compared at both time points, evaluating if the MRT demonstrates clinically sufficient stability in its findings (i.e., does the MRT report an accurate and similar result at both time points).
Diagnostic test: MRT Accuracy
Predicted Grade Group (GG) by the MRI-based Radiomics Tool (MRT) at each Magnetic Resonance Imaging of the Prostate (MRI-P)
Diagnostic test: MRT Stability
MRT's predicted GG at second MRI-P.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
MRT Classification Change
Time Frame: Baseline, 8 weeks
Stability of participants' MRT classification (each of the five GG groups) between two shortly spaced MRIs.
Baseline, 8 weeks
MRT Classification: Baseline
Time Frame: Baseline
The accuracy of the GG classification from the MRT. Will be compared to the Gold Standard - prostate biopsy results. The percentage of MRT classifications that show agreement between the two methods (i.e. Gold Standard and MRT) in terms of GG classification will be reported.
Baseline
MRT Classification: Week 8
Time Frame: 8 weeks
The accuracy of the GG classification from the MRT. Will be compared to the Gold Standard - prostate biopsy results. The percentage of MRT classifications that show agreement between the two methods (i.e. Gold Standard and MRT) in terms of GG classification will be reported.
8 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Model optmization with novel radiomic features and clinical covariates
Time Frame: At study completion, 2 years.

Gwet's first order agreement coefficient; McNemar's test to test agreement across the two time points, regarding GG classification agreement.

Intra-class correlation coefficient (ICC) will to test the reliability of individual radiomic features at time points 1 and 2. Stability will be defined as an ICC ≥0.85.

Ordinal logistic regression with a cumulative logic link will be used to model GG classification. Clinical covariates, PIRADS scores, and exclusively "reliable" radiomic features will be explored in secondary analyses.
At study completion, 2 years.

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Nova Scotia Health Authority

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Dr. Michael Kucharczyk, Nova Scotia Health Authority

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 4, 2022

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 27, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 14, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 26, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 27, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 21, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 19, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 1026856

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Sharing Time Frame

Will be reported at study completion, expected in 2023.

IPD Sharing Access Criteria

The study protocol and SAP will be shared in the publication. Analytic code and images will be shared with collaborating institutions and groups that have agreed to a data sharing agreement with the investigators.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE

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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Conditions

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