Optimization of Prostate Biopsy - Micro-Ultrasound Versus MRI

Study Overview
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Brief Summary
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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
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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.

Official Title
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Optimization of Prostate Biopsy - Micro-Ultrasound Versus MRI: A 3-arm Randomized Controlled Trial Evaluating the Role of 29MHz Micro-ultrasound in Guiding Prostate Biopsy in Men With Clinical Suspicion of Prostate Cancer.

Conditions
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Prostate Cancer

Intervention / Treatment
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* Diagnostic Test: Micro-US Targeted Biopsy
* Diagnostic Test: MRI Targeted Biopsy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Men indicated for prostate biopsy due to elevated PSA and/or abnormal DRE 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 Exclusion Criteria: History of prior prostate biopsy History of genitourinary cancer, including prostate cancer Contraindications to biopsy Contraindications to mpMRI

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: All three arms will be active at the same time and subjects will be randomized to one arm.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Micro-US Only<br>Subjects will undergo biopsy using micro-ultrasound only. | Diagnostic Test: Micro-US Targeted Biopsy<br>* All subjects will be biopsied no matter their arm randomization. In this group, MicroUS targets will be identified and sampled.<br>|
| Active Comparator: mpMRI + Micro-US<br>Subjects will undergo fusion biopsy using mpMRI and micro-ultrasound | Diagnostic Test: Micro-US Targeted Biopsy<br>* All subjects will be biopsied no matter their arm randomization. In this group, MicroUS targets will be identified and sampled.<br>Diagnostic Test: MRI Targeted Biopsy<br>* All subjects will be biopsied no matter their arm randomization. In this group, MRI targets will be identified and sampled.<br>|
| Active Comparator: mpMRI Only<br>Subjects will undergo biopsy using mpMRI fused with regular ultrasound | Diagnostic Test: MRI Targeted Biopsy<br>* All subjects will be biopsied no matter their arm randomization. In this group, MRI targets will be identified and sampled.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference in csPCa rate between mpMRI-based and MicroUS-based biopsy techniques | 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. | Immediately after biopsy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference in csPCa rate between conventional mpMRI/US fusion biopsy and mpMRI/MicroUS fusion 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). | Immediately after biopsy | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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prostate, prostate biopsy, micro-ultrasound