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Diagnostic Test

Micro-Ultrasound vs MRI-Guided Biopsy for Prostate Cancer (OPTIMUM Trial)

N/A
Recruiting
Led By Laurence Klotz
Research Sponsored by Sunnybrook Health Sciences Centre
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
No history of genitourinary cancer, including prostate cancer
Men indicated for prostate biopsy due to elevated PSA and/or abnormal DRE
Must not have
Contraindications to biopsy
History of genitourinary cancer, including prostate cancer
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 7 days after biopsy
Awards & highlights
No Placebo-Only Group

Summary

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

Who is the study for?
This trial is for men who need a prostate biopsy because of high PSA levels or abnormal DRE results. They must be over 18, have no history of genitourinary cancer including prostate cancer, and no previous prostate biopsies. They also shouldn't have any conditions that would prevent them from having an MRI or a biopsy.
What is being tested?
The OPTIMUM study is comparing two methods to guide prostate biopsies: micro-ultrasound (microUS) and multiparametric MRI (mpMRI)/US fusion. The goal is to see which one is better at detecting abnormalities during the biopsy process.
What are the potential side effects?
Potential side effects may include discomfort or pain at the biopsy site, bleeding, infection risk from the procedure, and possible allergic reactions to materials used in either micro-US or mpMRI.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have never had cancer in my urinary or reproductive organs.
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I am a man recommended for a prostate biopsy because of high PSA or an abnormal exam.
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I am 18 years old or older.
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I can safely undergo a biopsy.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I cannot undergo a biopsy due to health risks.
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I have had cancer in my urinary system or prostate.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~7 days after biopsy
This trial's timeline: 3 weeks for screening, Varies for treatment, and 7 days after biopsy for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Difference in csPCa rate between mpMRI-based and MicroUS-based biopsy techniques
Secondary study objectives
Difference in csPCa rate between conventional mpMRI/US fusion biopsy and mpMRI/MicroUS fusion biopsy
Other study objectives
Added cases of csPCa detected by each biopsy technique
Cost of Interventions
Patient Satisfaction using a modified PROBE Questionnaire
+2 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups
Active Control
Group I: Micro-US OnlyActive Control1 Intervention
Subjects will undergo biopsy using micro-ultrasound only.
Group II: mpMRI + Micro-USActive Control2 Interventions
Subjects will undergo fusion biopsy using mpMRI and micro-ultrasound
Group III: mpMRI OnlyActive Control1 Intervention
Subjects will undergo biopsy using mpMRI fused with regular ultrasound

Find a Location

Who is running the clinical trial?

Sunnybrook Health Sciences CentreLead Sponsor
674 Previous Clinical Trials
1,564,655 Total Patients Enrolled
31 Trials studying Prostate Cancer
10,881 Patients Enrolled for Prostate Cancer
Exact ImagingIndustry Sponsor
5 Previous Clinical Trials
1,941 Total Patients Enrolled
4 Trials studying Prostate Cancer
1,855 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

Media Library

Micro-US Targeted Biopsy (Diagnostic Test) Clinical Trial Eligibility Overview. Trial Name: NCT05220501 — N/A
Prostate Cancer Research Study Groups: Micro-US Only, mpMRI + Micro-US, mpMRI Only
Prostate Cancer Clinical Trial 2023: Micro-US Targeted Biopsy Highlights & Side Effects. Trial Name: NCT05220501 — N/A
Micro-US Targeted Biopsy (Diagnostic Test) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05220501 — N/A
~253 spots leftby Nov 2025
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