Clinical trial NCT05024162: Can MRI of the Prostate Combined With a Radiomics Evaluation Determine the Invasive Capacity of a Tumour
Official title: Can Magnetic Resonance Imaging of the Prostate Combined With a Radiomics Evaluation Determine the Invasive Capacity of a Tumour (Can MRI-PREDICT)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Prostate Cancer
Keywords: Magnetic Resonance Imaging
Radiomics
Non-invasive
Cancer Diagnosis
Staging
Prostate Cancer
Lead sponsor: Nova Scotia Health Authority
Sponsor class: OTHER
First posted: 2021-08-27
Enrollment: 60
Sex: MALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: MRT Classification Change
timeFrame: Baseline, 8 weeks
measure: MRT Classification: Baseline
timeFrame: Baseline
measure: MRT Classification: Week 8
timeFrame: 8 weeks
Secondary outcomes:
measure: Model optmization with novel radiomic features and clinical covariates
timeFrame: At study completion, 2 years.
Other outcomes:
Locations:
city: Halifax
country: Canada
facility: Victoria General Hospital
state: Nova Scotia
Study officials:
affiliation: Nova Scotia Health Authority
name: Dr. Michael Kucharczyk
role: PRINCIPAL_INVESTIGATOR
References:
citation: Epstein JI, Egevad L, Amin MB, Delahunt B, Srigley JR, Humphrey PA; Grading Committee. The 2014 International Society of Urological Pathology (ISUP) Consensus Conference on Gleason Grading of Prostatic Carcinoma: Definition of Grading Patterns and Proposal for a New Grading System. Am J Surg Pathol. 2016 Feb;40(2):244-52. doi: 10.1097/PAS.0000000000000530.
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