Optimization of Prostate Biopsy - Micro-Ultrasound Versus MRI

NCT05220501 | Completed Results FDA Device

• 1 other identifier: EVU-2021-001
• Study Type: interventional
• Target: 804
• Locations: 8 countries
• Sites: 22

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.

Conditions

Prostate Cancer

Keywords

prostate; prostate biopsy; micro-ultrasound

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Difference in csPCa Rate Between MicroUS/MRI- Guided Fusion Biopsy and MRI/Conventional Ultrasonography Guided Fusion Biopsy

  Immediately after biopsy

Study Arms (3)

Microultrasonography only

ACTIVE COMPARATOR

Subjects will undergo biopsy using micro-ultrasound only.

Diagnostic Test: Microultrasonography Targeted Biopsy

Microultrasonography + MRI

ACTIVE COMPARATOR

Subjects will undergo fusion biopsy using mpMRI and micro-ultrasound

Diagnostic Test: Microultrasonography Targeted Biopsy; Diagnostic Test: MRI Targeted Biopsy

MRI + Conventional Ultrasonography

ACTIVE COMPARATOR

Subjects will undergo biopsy using mpMRI fused with regular ultrasound

Diagnostic Test: MRI Targeted Biopsy

Interventions

Microultrasonography Targeted Biopsy DIAGNOSTIC_TEST

All subjects will be biopsied no matter their arm randomization. In this group, MicroUS targets will be identified and sampled.

Microultrasonography + MRI; Microultrasonography only

MRI Targeted Biopsy DIAGNOSTIC_TEST

All subjects will be biopsied no matter their arm randomization. In this group, mpMRI targets will be identified and sampled.

MRI + Conventional Ultrasonography; Microultrasonography + MRI

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Participants need to have a prostate and have been referred to a urologist
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

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

Sponsors & Collaborators

• Sunnybrook Health Sciences Centre: lead
• Exact Imaging: collaborator

Study Sites (22)

UCLA

Los Angeles, California, 90095, United States

Location

Yale University

New Haven, Connecticut, 06511, United States

Location

University of Florida Health

Gainsville, Florida, 32611, United States

Location

Johns Hopkins

Baltimore, Maryland, 21205, United States

Location

Carolina Urologic Research Center

Myrtle Beach, South Carolina, 29572, United States

Location

Ordensklinikum Elisabethinen

Linz, Austria

Location

Hopital Delta

Brussels, Belgium

Location

University of Alberta

Edmonton, Alberta, T6G1Z1, Canada

Location

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N3M5, Canada

Location

University Health Network - Princess Margaret Hospital

Toronto, Ontario, M5G 2C4, Canada

Location

Hôpital Maisonneuve-Rosemont

Montreal, Quebec, H1T 2M4, Canada

Location

Hôpital du Sacré-Cœur de Montréal

Montreal, Quebec, H4J 1C5, Canada

Location

Centre Hospitàlier Martigues, Hôpitaux de Provence

Martigues, France

Location

L'Institut Mutualiste Montsouris

Paris, France

Location

University of Brandenburg

Brandenburg, Brandenburg, Germany

Location

University of Magdeburg

Magdeburg, Saxony-Anholt, 39120, Germany

Location

ProUro

Berlin, Germany

Location

University of Tuebingen

Tübingen, Germany

Location

Humanitas

Milan, Italy

Location

Urologica Clinica Bilbao

Bilbao, Spain

Location

Madrid ROC

Madrid, 28010, Spain

Location

ICUA Madrid

Madrid, Spain

Location

Related Publications (1)

• 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.

  PMID: 40121537 BACKGROUND

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Limitations and Caveats

Study mandated biopsy for all men in the trial. Currently, many men with PI-RAD 1 or 2 scores and favorable PSA density avoid biopsy. Trial design was open-label so no study member was blinded to biopsy technique. MRI/ultrasonography fusion device was not standardized across sites. Investigators used the device they were most comfortable with. Study restricted to biopsy naive men, therefore did not address microultrasonography in other clinical scenarios (i.e. active surveillance).

Results Point of Contact

• Title: Dr. Laurence Klotz
• Organization: Sunnybrook Health Sciences Centre

Laurence.Klotz@sunnybrook.ca

+1. 416 480 4673

Study Officials

• Laurence Klotz, MD

  Sunnybrook Health Sciences Centre

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Affiliate Scientist

Model Details: All three arms will be active at the same time and subjects will be randomized to one arm.

Study Record Dates

• First Submitted: December 9, 2021
• First Posted: February 2, 2022
• Study Start: December 15, 2021
• Primary Completion: September 6, 2024
• Study Completion: September 6, 2024
• Last Updated: November 10, 2025
• Results First Posted: November 10, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1); DE (4); CA (5); ES (3); AU (1); BE (1); US (5); FR (2)