Micro-US Only for Prostate Cancer

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Prostate Cancer+1 More
Micro-US Targeted Biopsy - DiagnosticTest
Eligibility
18+
Male
What conditions do you have?
Select

Study Summary

This trial will compare ultrasounds and MRIs to see which is better at guiding prostate biopsies.

Eligible Conditions
  • Prostate Cancer

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 1 Secondary · Reporting Duration: Immediately after biopsy

7 days after biopsy
Cost of Interventions
Patient Satisfaction using a modified PROBE Questionnaire
Procedure Time of Interventions
Immediately after biopsy
Added cases of csPCa detected by each biopsy technique
Difference in csPCa rate between conventional mpMRI/US fusion biopsy and mpMRI/MicroUS fusion biopsy
Difference in csPCa rate between mpMRI-based and MicroUS-based biopsy techniques
Biopsy

Trial Safety

Trial Design

3 Treatment Groups

Micro-US Only
1 of 3
mpMRI + Micro-US
1 of 3
mpMRI Only
1 of 3

Active Control

1200 Total Participants · 3 Treatment Groups

Primary Treatment: Micro-US Only · No Placebo Group · N/A

Micro-US Only
DiagnosticTest
ActiveComparator Group · 1 Intervention: Micro-US Targeted Biopsy · Intervention Types: DiagnosticTest
mpMRI + Micro-USActiveComparator Group · 2 Interventions: Micro-US Targeted Biopsy, MRI Targeted Biopsy · Intervention Types: DiagnosticTest, DiagnosticTest
mpMRI Only
DiagnosticTest
ActiveComparator Group · 1 Intervention: MRI Targeted Biopsy · Intervention Types: DiagnosticTest

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: immediately after biopsy

Who is running the clinical trial?

Exact ImagingIndustry Sponsor
5 Previous Clinical Trials
1,941 Total Patients Enrolled
5 Trials studying Prostate Cancer
1,941 Patients Enrolled for Prostate Cancer
Sunnybrook Health Sciences CentreLead Sponsor
599 Previous Clinical Trials
1,467,216 Total Patients Enrolled
32 Trials studying Prostate Cancer
9,010 Patients Enrolled for Prostate Cancer
Laurence KlotzPrincipal InvestigatorSunnybrook Hospital
1 Previous Clinical Trials
65 Total Patients Enrolled
1 Trials studying Prostate Cancer
65 Patients Enrolled for Prostate Cancer

Eligibility Criteria

Age 18+ · Male Participants · 6 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You must be at least 18 years old.
You are men with elevated PSA and/or abnormal DRE.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 22nd, 2021

Last Reviewed: November 20th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.