Recruiting

Radiomics Evaluation

Sponsor:

Nova Scotia Health Authority

Code:

NCT05024162

Conditions

Prostate Cancer

Eligibility Criteria

Sex: Male

Age: 0+

Healthy Volunteers: Not accepted

Interventions

MRT Accuracy

MRT Stability

Study Details

Brief summary:

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.

Conditions

Prostate Cancer

Study ID

NCT05024162

Start date

Jan 4, 2022

Status verified date

Aug, 2024

Completion date

Sep 1, 2025

Anticipated

Primary completion date

Aug 27, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 0+

Healthy Volunteers: Not accepted

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 Design

Enrollment

60 participants

Anticipated

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

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).

Interventions

MRT Accuracy

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

MRT Stability

MRT's predicted GG at second MRI-P.

Primary outcome measure

  • MRT Classification Change [ Time Frame: Baseline, 8 weeks ]
  • MRT Classification: Baseline [ Time Frame: Baseline ]
  • MRT Classification: Week 8 [ Time Frame: 8 weeks ]

Central Contacts and Locations

Central contacts

Beverly A Lieuwen, BSc

9024735315beverly.lieuwen@iwk.nshealth.ca

Dr. Michael Kucharczyk

9024736185

Locations

Victoria General Hospital

Recruiting

Halifax, Nova Scotia, Canada, B3H1V7

Contacts

Michael J Kucharczyk, MB BCh BAO MPH FRCPC

9024736185michael.kucharczyk@medportal.ca

Beverly Lieuwen

Beverly.Lieuwen@iwk.nshealth.ca

More Information

Sponsor

Nova Scotia Health Authority

Last update posted

Aug 21, 2024

Last verified

Aug, 2024

Keywords

  • Magnetic Resonance Imaging
  • Radiomics
  • Non-invasive
  • Cancer Diagnosis
  • Staging
  • Prostate Cancer

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Nova Scotia Health Authority on 2024-08-21.