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NCT Number: NCT05024162

Can MRI of the Prostate Combined With a Radiomics Evaluation Determine the Invasive Capacity of a Tumour

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.

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Key information

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Victoria General Hospital

Halifax, Nova Scotia, B3H1V7, Canada

Location status: Recruiting

Location contact

Beverly Lieuwen

CONTACT

[email protected]

Michael J Kucharczyk, MB BCh BAO MPH FRCPC

CONTACT

[email protected]

9024736185

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MRT Accuracy

Diagnostic Test

Predicted Grade Group (GG) by the MRI-based Radiomics Tool (MRT) at each Magnetic Resonance Imaging of the Prostate (MRI-P)

MRT Stability

Diagnostic Test

MRT's predicted GG at second MRI-P.

Primary outcomes

  1. MRT Classification Change

    Time frame: Baseline, 8 weeks

    Stability of participants' MRT classification (each of the five GG groups) between two shortly spaced MRIs.

  2. 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.

  3. 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.

Secondary outcomes

  1. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Beverly A Lieuwen, BSc

CONTACT

[email protected]

9024735315

Dr. Michael Kucharczyk

CONTACT

9024736185

Sponsors and collaborators

Lead sponsor

Nova Scotia Health Authority

Other

Registry information

Official study title

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

Acronym: MRI-PREDICT

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Aug 27, 2021
Registry last updated
Aug 21, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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