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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 7 days after biopsy

Awards & highlights

OPTIMUM Trial 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.Check my eligibility

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.See study design

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.

OPTIMUM Trial 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.

OPTIMUM Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ immediately after biopsy

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~immediately after biopsy

This trial's timeline: 3 weeks for screening, Varies for treatment, and immediately after biopsy for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Difference in csPCa rate between mpMRI-based and MicroUS-based biopsy techniques

Secondary outcome measures

Difference in csPCa rate between conventional mpMRI/US fusion biopsy and mpMRI/MicroUS fusion biopsy

Other outcome measures

Added cases of csPCa detected by each biopsy technique

Cost of Interventions

Patient Satisfaction using a modified PROBE Questionnaire

+2 more

OPTIMUM 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

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Sunnybrook Health Sciences CentreLead Sponsor

656 Previous Clinical Trials

1,550,108 Total Patients Enrolled

34 Trials studying Prostate Cancer

11,438 Patients Enrolled for Prostate Cancer

Exact ImagingIndustry Sponsor

5 Previous Clinical Trials

1,941 Total Patients Enrolled

5 Trials studying Prostate Cancer

1,941 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this research project continue to accept new participants?

"The clinical trial that was originally posted on February 1st 2022 is not currently enrolling patients. The last edit to the study occurred January 20th 2022, but 1322 other medical trials are actively recruiting at this time."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Optimization of Prostate Biopsy - Micro-Ultrasound Versus MRI

Dr. Laurence Klotz 2021. "Optimization of Prostate Biopsy - Micro-Ultrasound Versus MRI". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05220501.

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