Clinical trial NCT03938376: Micro-Ultrasound/Magnetic Resonance Imaging 001
Official title: Comparison of Micro-ultrasound Targeted Biopsy to mpMRI of Prostate for Detection of Clinically Significant Prostate Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diagnoses Disease
Keywords: Prostatic Disease
Diagnostic Imaging
Micro-Ultrasound
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
First posted: 2019-05-06
Enrollment: 100
Sex: MALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who are referred to confirm negative or positive for diagnosis of prostate cancer based on SOC biopsy, with superior resolution imaging devices. Referral may be indicated in the setting of increased PSA, abnormal DRE and/or abnormality of other serum or urinary tests specific for prostate cancer, for example PHI (Prostate Health Index) and PCA3. The current golden standard imaging for prostate cancer is mpMRI.

Brief summary: Micro-ultrasound is a novel real-time imaging modality which maintains the clinical workflow of conventional ultrasound-guided prostate biopsy, while potentially maintaining a similar ability to detect clinically significant prostate cancer (csPCa) to MRI. This prospective trial aims to compare micro-ultrasound to mpMRI in detection of csPCa in the biopsy naïve.

Detailed description: Evidence from a large randomized clinical trial (clinical trials.gov ID NCT02079025), suggests that micro-ultrasound system is more sensitive than conventional transrectal-ultrasound (TRUS) to detect prostate cancer (PCa). the PRI-MUS (prostate risk identification using micro-ultrasound) scoring system was developed and validated to assess the risk of prostate cancer for targeted biopsy with the micro-ultrasound platform, similar to the PIRADS scoring system for suspicious areas on mpMRI. This project will compare micro-ultrasound imaging modality to the current gold-standard imaging for prostate cancer, mpMRI. By applying both modalities to the same patients, the investigators will provide a direct comparison of their screening abilities in terms of sensitivity, specificity, negative predictive value and positive predictive value. It will build evidence to demonstrate that micro-ultrasound may replace MRI/Fusion biopsy in these patients.This project aims to demonstrate that the micro-ultrasound 1) provides more sensitive initial biopsy, reducing the need for repeated procedures, thus lowering the rate of severe sepsis and the number of cancers found after local or regional progression, and 2) reduces the need for mpMRI following initial biopsy.

Eligibility criteria: Inclusion Criteria:

* Men with indication for a prostate biopsy will be offered inclusion in the study. Indications for biopsy include clinical suspicion of prostate cancer due to elevated PSA or abnormal digital rectal exam (DRE)

Exclusion Criteria:

* Patients with history of prostate cancer
* Patients with prior prostate biopsies
* Patients who are unwilling or unable to give informed consent
* Patients with contraindication to MRI (i.e. pacemaker, hip prosthesis, severe claustrophobia, brain aneurysm clip, allergy to MRI contrast agent)

Primary outcomes:
measure: The proportion of csPCa detected for each modality.
timeFrame: 1.5 years
Secondary outcomes:
measure: The proportion of zones of PCa correctly predicted by each modality in the whole-mount pathology specimen for the subset of men selecting radical prostatectomy for treatment.
timeFrame: 1.5 years
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Princess Margaret Cancer Centre
state: Ontario
Study officials:
affiliation: University Health Network, Toronto
name: Sangeet Ghai, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ghai S, Perlis N, Atallah C, Jokhu S, Corr K, Lajkosz K, Incze PF, Zlotta AR, Jain U, Fleming H, Finelli A, van der Kwast TH, Haider MA. Comparison of Micro-US and Multiparametric MRI for Prostate Cancer Detection in Biopsy-Naive Men. Radiology. 2022 Nov;305(2):390-398. doi: 10.1148/radiol.212163. Epub 2022 Jul 19.