Micro-Ultrasound/Magnetic Resonance Imaging 001

NCT03938376 | Completed

• 1 other identifier: 19-5042.0
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Diagnoses Disease

Keywords

Prostatic Disease; Diagnostic Imaging; Micro-Ultrasound

Outcome Measures

Primary Outcomes (1)

• The proportion of csPCa detected for each modality.

  Micro-ultrasound targeted biopsy will provide a non-inferior sensitivity to detect clinically significant prostate cancer compared to multiparametric MRI.

  1.5 years

Secondary Outcomes (1)

• 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.

  1.5 years

Study Arms (1)

Potential Prostate Cancer

Biopsy naïve patients with rising Prostate Specific Antigen (PSA) results referred by their Urologist for a standard of care (SOC) biopsy.

Diagnostic Test: Micro-Ultrasound guided biopsy

Interventions

Micro-Ultrasound guided biopsy DIAGNOSTIC_TEST

High-resolution imaging device

Potential Prostate Cancer

Eligibility Criteria

• Gender Eligibility Details: Based on the individual's biology, must have suspicion for prostate cancer based on Prostate Specific Antigen (PSA) results.
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• University Health Network, Toronto: lead

Study Sites (1)

Princess Margaret Cancer Centre

Toronto, Ontario, Canada

Location

Related Publications (1)

• 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.

  PMID: 35852425 DERIVED

MeSH Terms

Conditions

Prostatic Diseases

Condition Hierarchy (Ancestors)

Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Sangeet Ghai, MD

  University Health Network, Toronto

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 3, 2019
• First Posted: May 6, 2019
• Study Start: May 24, 2019
• Primary Completion: September 14, 2020
• Study Completion: February 1, 2021
• Last Updated: April 1, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)