Optimization of Prostate Biopsy - Micro-Ultrasound Versus MRI

Not Applicable

Completed

• Conditions: Prostate Cancer
• Interventions: Diagnostic Test: Micro-US Targeted Biopsy; Diagnostic Test: MRI Targeted Biopsy

• Registration Number: NCT05220501
• Lead Sponsor: Sunnybrook Health Sciences Centre

Brief Summary

OPTIMUM is a study designed to compare the ability of ultra-high resolution transrectal micro-ultrasound (microUS) and multiparametric MRI (mpMRI)/US fusion to guide prostate biopsy.

Detailed Description

The purpose of the Clinical Investigation Plan and Study Protocol is to present information for the OPTIMUM clinical investigation, including the scientific basis for the study, the procedural details, the ExactVu High Resolution Micro-Ultrasound System, its safety details, and administrative details. It has been designed in such a way as to optimize the scientific validity and reproducibility of the results of the study in accordance with current clinical knowledge and practice so as to fulfill the objectives of the investigation.

Study Timeline

• Study First Submitted: 2021-12-09
• Study Start: 2021-12-15
• Study First Submitted QC: 2022-01-20
• Study First Posted: 2022-02-02
• Primary Completion: 2024-09-06
• Status Verified: 2024-11
• Study Completion: 2024-11-06
• Last Update Submitted: 2024-11-18
• Last Update Posted: 2024-11-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 804

Inclusion Criteria

• Men indicated for prostate biopsy due to elevated Prostate Specific Antigen and/or abnormal Digital Rectal Examination
• No history of prior prostate biopsy
• No history of genitourinary cancer, including prostate cancer
• 18 years or older
• No contraindications to biopsy
• No contraindications to mpMRI
• No history of mpMRI for clinical investigation of prostate cancer within 12 months prior to screening and enrollment in the study

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Exclusion Criteria

• History of prior prostate biopsy
• History of genitourinary cancer, including prostate cancer
• Contraindications to biopsy
• Contraindications to mpMRI

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Micro-US Only	Micro-US Targeted Biopsy	Subjects will undergo biopsy using micro-ultrasound only.
mpMRI + Micro-US	MRI Targeted Biopsy	Subjects will undergo fusion biopsy using mpMRI and micro-ultrasound
mpMRI Only	MRI Targeted Biopsy	Subjects will undergo biopsy using mpMRI fused with regular ultrasound
mpMRI + Micro-US	Micro-US Targeted Biopsy	Subjects will undergo fusion biopsy using mpMRI and micro-ultrasound

Primary Outcome Measures

Name	Time	Method
Difference in csPCa rate between mpMRI-based and MicroUS-based biopsy techniques	Immediately after biopsy	Difference in detection rate of Grade Group \> 1 Prostate Cancer (csPCa) found during biopsy between the two biopsy interventions tested: mpMRI Biopsy and MicroUS Biopsy.

Secondary Outcome Measures

Name	Time	Method
Difference in csPCa rate between conventional mpMRI/US fusion biopsy and mpMRI/MicroUS fusion biopsy	Immediately after biopsy	Difference in detection rate of Grade Group \> 1 Prostate Cancer (csPCa) found during biopsy between the two fusion biopsy techniques used: conventional mpMRI/US Biopsy (mpMRI+US arm) and mpMRI/MicroUS Biopsy (mpMRI + Micro-US arm).

Trial Locations

Locations (22)

Johns Hopkins; 🇺🇸 Baltimore, Maryland, United States

Sunnybrook Health Sciences Centre; 🇨🇦 Toronto, Ontario, Canada

Hôpital Maisonneuve-Rosemont; 🇨🇦 Montréal, Quebec, Canada

Hôpital du Sacré-Cœur de Montréal; 🇨🇦 Montréal, Quebec, Canada

Centre Hospitàlier Martigues, Hôpitaux de Provence; 🇫🇷 Martigues, France

University of Tuebingen; 🇩🇪 Tuebingen, Germany

Humanitas; 🇮🇹 Milano, Italy

Madrid ROC; 🇪🇸 Madrid, Spain

UCLA; 🇺🇸 Los Angeles, California, United States

Yale University; 🇺🇸 New Haven, Connecticut, United States

University of Florida Health; 🇺🇸 Gainsville, Florida, United States

Carolina Urologic Research Center; 🇺🇸 Myrtle Beach, South Carolina, United States

Ordensklinikum Elisabethinen; 🇦🇹 Linz, Austria

Hopital Delta; 🇧🇪 Brussels, Belgium

University of Alberta; 🇨🇦 Edmonton, Alberta, Canada

University Health Network - Princess Margaret Hospital; 🇨🇦 Toronto, Ontario, Canada

L'Institut Mutualiste Montsouris; 🇫🇷 Paris, France

University of Magdeburg; 🇩🇪 Magdeburg, Saxony-Anholt, Germany

ProUro; 🇩🇪 Berlin, Germany

University of Brandenburg; 🇩🇪 Brandenburg, Germany

Urologica Clinica Bilbao; 🇪🇸 Bilbao, Spain

ICUA Madrid; 🇪🇸 Madrid, Spain