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

Status: Recruiting
Location: See location...
Intervention Type: Diagnostic test
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: Male
Healthy Volunteers: f
View:

⁃ 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

Locations
Other Locations
Canada
Victoria General Hospital
RECRUITING
Halifax
Contact Information
Primary
Beverly A Lieuwen, BSc
beverly.lieuwen@iwk.nshealth.ca
9024735315
Backup
Dr. Michael Kucharczyk
9024736185
Time Frame
Start Date: 2022-01-04
Estimated Completion Date: 2025-09-01
Participants
Target number of participants: 60
Treatments
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).
Related Therapeutic Areas
Sponsors
Leads: Nova Scotia Health Authority

This content was sourced from clinicaltrials.gov