Optimization of Prostate Biopsy - Micro-Ultrasound Versus MRI (OPTIMUM)

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.

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.

Study Overview

• Status: Completed
• Conditions: Prostate Cancer
• Intervention / Treatment: Diagnostic test: Microultrasonography Targeted Biopsy; Diagnostic test: MRI Targeted 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 Type: Interventional
• Enrollment (Actual): 804
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Austria
  • Linz, Austria
    • Ordensklinikum Elisabethinen
• Belgium
  • Brussels, Belgium
    • Hopital Delta
• Canada
  • Alberta
    • Edmonton, Alberta, Canada, T6G1Z1
      • University of Alberta
  • Ontario
    • Toronto, Ontario, Canada, M4N3M5
      • Sunnybrook Health Sciences Centre
    • Toronto, Ontario, Canada, M5G 2C4
      • University Health Network - Princess Margaret Hospital
  • Quebec
    • Montreal, Quebec, Canada, H4J 1C5
      • Hopital du Sacre-Coeur de Montreal
    • Montreal, Quebec, Canada, H1T 2M4
      • Hôpital Maisonneuve-Rosemont
• France
  • Martigues, France
    • Centre Hospitàlier Martigues, Hôpitaux de Provence
  • Paris, France
    • L'Institut Mutualiste Montsouris
• Germany
  • Berlin, Germany
    • ProUro
  • Tübingen, Germany
    • University of Tuebingen
  • Brandenburg
    • Brandenburg, Brandenburg, Germany
      • University of Brandenburg
  • Saxony-Anholt
    • Magdeburg, Saxony-Anholt, Germany, 39120
      • University of Magdeburg
• Italy
  • Milan, Italy
    • Humanitas
• Spain
  • Bilbao, Spain
    • Urologica Clinica Bilbao
  • Madrid, Spain, 28010
    • Madrid ROC
  • Madrid, Spain
    • ICUA Madrid
• United States
  • California
    • Los Angeles, California, United States, 90095
      • UCLA
  • Connecticut
    • New Haven, Connecticut, United States, 06511
      • Yale University
  • Florida
    • Gainsville, Florida, United States, 32611
      • University of Florida Health
  • Maryland
    • Baltimore, Maryland, United States, 21205
      • Johns Hopkins
  • South Carolina
    • Myrtle Beach, South Carolina, United States, 29572
      • Carolina Urologic Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Microultrasonography only; Subjects will undergo biopsy using micro-ultrasound only.	Diagnostic test: Microultrasonography Targeted Biopsy; All subjects will be biopsied no matter their arm randomization. In this group, MicroUS targets will be identified and sampled.
Active Comparator: Microultrasonography + MRI; Subjects will undergo fusion biopsy using mpMRI and micro-ultrasound	Diagnostic test: Microultrasonography Targeted Biopsy; All subjects will be biopsied no matter their arm randomization. In this group, MicroUS targets will be identified and sampled.; Diagnostic test: MRI Targeted Biopsy; All subjects will be biopsied no matter their arm randomization. In this group, mpMRI targets will be identified and sampled.
Active Comparator: MRI + Conventional Ultrasonography; Subjects will undergo biopsy using mpMRI fused with regular ultrasound	Diagnostic test: MRI Targeted Biopsy; All subjects will be biopsied no matter their arm randomization. In this group, mpMRI targets will be identified and sampled.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Difference in Detection of Gleason Grade Group 2 or Higher Cancers Using Microultrasonography Plus Systematic Biopsy vs mpMRI/Conventional Ultrasonography Plus Systematic Biopsy	As per protocol, the microultrasonography group for the primary outcome is defined as the microultrasonography-guided biopsy group and the blinded portion (microultrasound targets are identified prior to the unblinding of the MRI targets identified in the microultrasonography/mpMRI group). Difference in the detection rate of clinically significant prostate cancer (defined as equal to Gleason Grade Group 2 or higher) found using microultrasonography-guided biopsy, including targeted and systematic samples from the microultrasonography group and the mpMRI-blinded portion of the microultrasonography/mpMRI group, versus mpMRI/conventional ultrasonography-guided biopsy, including targeted and systematic samples from the mpMRI/conventional ultrasonography group.	Post biopsy

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Difference in csPCa Rate Between MicroUS/MRI- Guided Fusion Biopsy and MRI/Conventional Ultrasonography Guided Fusion Biopsy	The secondary outcome, detection of clinically significant prostate cancer by combined microultrasonography/mpMRI-guided fusion biopsy vs mpMRI/conventional ultrasonography-guided fusion biopsy.	Immediately after biopsy

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Prediction of biopsy outcome using imaging risk scores	Difference in negative predictive value of highest risk score per patient for prediction of csPCa on biopsy	Immediately after biopsy
Cost of Interventions	Comparison of cost, in dollars, of interventions in each arm.	7 days after biopsy
Procedure Time of Interventions	Comparison of procedure time, in minutes, of interventions in each arm.	7 days after biopsy
Number of Clinically Significant Prostate Cancer (csPCa) cases found exclusively by each biopsy strategy	Added value (in additional cases of csPCa detected) of each biopsy technique (mpMRI Targeted, MicroUS Targeted, Systematic) when added to the others to optimize the biopsy protocol.	Immediately after biopsy
Patient Satisfaction using a modified Prostate Biopsy Effects (ProBE) Questionnaire	Comparison of patient satisfaction using the Perception subset of questions from the PROBE Questionnaire of the ProTect study. Range from six to twenty-four.	7 days after biopsy

Collaborators and Investigators

• Sponsor: Sunnybrook Health Sciences Centre
• Collaborators: Exact Imaging
• Investigators: Principal Investigator: Laurence Klotz, MD, Sunnybrook Health Sciences Centre

Publications and helpful links

General Publications

• Kinnaird A, Luger F, Cash H, Ghai S, Urdaneta-Salegui LF, Pavlovich CP, Brito J, Shore ND, Struck JP, Schostak M, Harland N, Rodriguez-Socarras M, Brisbane WG, Lughezzani G, Toledano H, Ouertani MS, Macek P, Fung C, Tu W, Gusenleitner A, Gunzel K, Incze PF, George AK, Pereira JG, Jansen R, Renzulli J 2nd, Klotz L; OPTIMUM Investigators. Microultrasonography-Guided vs MRI-Guided Biopsy for Prostate Cancer Diagnosis: The OPTIMUM Randomized Clinical Trial. JAMA. 2025 May 20;333(19):1679-1687. doi: 10.1001/jama.2025.3579.

Study record dates

Study Major Dates

• Study Start (Actual): December 15, 2021
• Primary Completion (Actual): September 6, 2024
• Study Completion (Actual): September 6, 2024

Study Registration Dates

• First Submitted: December 9, 2021
• First Submitted That Met QC Criteria: January 20, 2022
• First Posted (Actual): February 2, 2022

Study Record Updates

• Last Update Posted (Estimated): November 7, 2025
• Last Update Submitted That Met QC Criteria: October 22, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Keywords: prostate biopsy; prostate; micro-ultrasound
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Prostatic Diseases; Male Urogenital Diseases; Prostatic Neoplasms
• Other Study ID Numbers: EVU-2021-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Contractual limitations

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No