Prostate CancerOPTIMUMNCT05220501
Optimization of Prostate Biopsy - Micro-Ultrasound Versus MRI
A study testing Microultrasonography Targeted Biopsy and MRI Targeted Biopsy in people with Prostate Cancer, run by Sunnybrook Health Sciences Centre at 22 sites in 8 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Microultrasonography Targeted Biopsy and MRI Targeted Biopsy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 804 participants
- Where
- 22 sitesin 8 countries
- Study dates
- 15 Dec 2021to 6 Sep 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- History of prior prostate biopsy
- History of genitourinary cancer, including prostate cancer
- Contraindications to biopsy
- Contraindications to mpMRI
Trial locations and contacts
22 sites in 8 countries.
22 sites in 8 countries
United States5 sites
Johns Hopkins
Baltimore, Maryland, 21205
University of Florida Health
Gainsville, Florida, 32611
UCLA
Los Angeles, California, 90095
Carolina Urologic Research Center
Myrtle Beach, South Carolina, 29572
Yale University
New Haven, Connecticut, 06511
Canada5 sites
University of Alberta
Edmonton, Alberta, T6G1Z1
Hôpital Maisonneuve-Rosemont
Montreal, Quebec, H1T 2M4
Hôpital du Sacré-Cœur de Montréal
Montreal, Quebec, H4J 1C5
Sunnybrook Health Sciences Centre
Toronto, Ontario, M4N3M5
University Health Network - Princess Margaret Hospital
Toronto, Ontario, M5G 2C4
Germany4 sites
ProUro
Berlin
University of Brandenburg
Brandenburg an der Havel, Brandenburg
University of Magdeburg
Magdeburg, Saxony-Anholt, 39120
University of Tuebingen
Tübingen
Spain3 sites
Urologica Clinica Bilbao
Bilbao
Madrid ROC
Madrid, 28010
ICUA Madrid
Madrid
France2 sites
Centre Hospitàlier Martigues, Hôpitaux de Provence
Martigues
L'Institut Mutualiste Montsouris
Paris
About this study
Official title: 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.
Read the 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.
- Conditions
- Prostate Cancer
- Being tested
- Microultrasonography Targeted Biopsy, MRI Targeted Biopsy
- Keywords
- prostate, prostate biopsy, micro-ultrasound
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Microultrasonography Targeted BiopsyDiagnostic test
All subjects will be biopsied no matter their arm randomization. In this group, MicroUS targets will be identified and sampled.
MRI Targeted BiopsyDiagnostic test
All subjects will be biopsied no matter their arm randomization. In this group, mpMRI targets will be identified and sampled.
| Study group | Role | What they receive |
|---|---|---|
| Microultrasonography only | Active comparator | Subjects will undergo biopsy using micro-ultrasound only. Receives: Diagnostic Test: Microultrasonography Targeted Biopsy |
| Microultrasonography + MRI | Active comparator | Subjects will undergo fusion biopsy using mpMRI and micro-ultrasound Receives: 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 Receives: Diagnostic Test: MRI Targeted Biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Post biopsy
Secondary outcomes (1)
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.
Measured: Immediately after biopsy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2022
- Study start15 Dec 2021
- Primary completion6 Sep 2024
- Study completion6 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by Sunnybrook Health Sciences CentreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- All three arms will be active at the same time and subjects will be randomized to one arm.
- Masking
- None (open label)
- Enrolment
- 804 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sunnybrook Health Sciences Centre
- Sponsor type
- University, hospital or other
- Collaborators
- Exact Imaging
- Responsible party
- Principal investigator, Dr. Laurence Klotz, Sunnybrook Health Sciences Centre
- Investigators
- Laurence Klotz, MD, Principal investigator, Sunnybrook Health Sciences Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05220501
- Sponsor's protocol ID
- EVU-2021-001
- Acronym
- OPTIMUM
- Status last verified
- Oct 2025
- First submitted
- 9 Dec 2021
- Last updated
- 10 Nov 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: Contractual limitations
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.
PubMed 40121537Lazarovich A, Guer M, 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, Kinnaird A. External Validation of the PRI-MUS Scoring System: A Secondary Analysis of the OPTIMUM Randomized Controlled Trial. J Urol. 2026 Sep;216(3):352-359. doi: 10.1097/JU.0000000000005082. Epub 2026 Apr 28.
PubMed 42048785
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT05220501
- Acronym / sponsor ID
- OPTIMUM / EVU-2021-001
- Conditions
- Prostate Cancer
- Keywords
- prostate, prostate biopsy, micro-ultrasound
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 804 participants (actual)
- Lead sponsor
- Sunnybrook Health Sciences CentreUniversity, hospital or other
- Collaborators
- Exact Imaging
- Study start
- 15 Dec 2021 (actual)
- Primary completion
- 6 Sep 2024 (actual)
- Study completion
- 6 Sep 2024 (actual)
- First posted
- 2 Feb 2022 (actual)
- Results
- Posted 10 Nov 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- All three arms will be active at the same time and subjects will be randomized to one arm.
| Arm | Type | Receives |
|---|---|---|
| Microultrasonography only | Active comparator | Diagnostic Test: Microultrasonography Targeted BiopsySubjects will undergo biopsy using micro-ultrasound only. |
| Microultrasonography + MRI | Active comparator | Diagnostic Test: Microultrasonography Targeted Biopsy, Diagnostic Test: MRI Targeted BiopsySubjects will undergo fusion biopsy using mpMRI and micro-ultrasound |
| MRI + Conventional Ultrasonography | Active comparator | Diagnostic Test: MRI Targeted BiopsySubjects will undergo biopsy using mpMRI fused with regular ultrasound |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (4 listed)
- History of prior prostate biopsy
- History of genitourinary cancer, including prostate cancer
- Contraindications to biopsy
- Contraindications to mpMRI
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Microultrasonography Targeted BiopsyAll subjects will be biopsied no matter their arm randomization. In this group, MicroUS targets will be identified and sampled. | Diagnostic test | Microultrasonography + MRI, Microultrasonography only |
| MRI Targeted BiopsyAll subjects will be biopsied no matter their arm randomization. In this group, mpMRI targets will be identified and sampled. | Diagnostic test | MRI + Conventional Ultrasonography, Microultrasonography + MRI |
Primary outcome
Difference in Detection of Gleason Grade Group 2 or Higher Cancers Using Microultrasonography Plus Systematic Biopsy vs mpMRI/Conventional Ultrasonography Plus Systematic Biopsy
Time frame: Post 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.
1 secondary outcome
Difference in csPCa Rate Between MicroUS/MRI- Guided Fusion Biopsy and MRI/Conventional Ultrasonography Guided Fusion Biopsy
Time frame: Immediately after biopsy
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Nov 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 40121537Kinnaird 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.
- Derived from this study: PubMed 42048785Lazarovich A, Guer M, 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, Kinnaird A. External Validation of the PRI-MUS Scoring System: A Secondary Analysis of the OPTIMUM Randomized Controlled Trial. J Urol. 2026 Sep;216(3):352-359. doi: 10.1097/JU.0000000000005082. Epub 2026 Apr 28.
- Individual participant dataSharing planned: No. Contractual limitations
Related trials for Prostate Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
Active, not recruitingObservational study
MRI Fusion Biopsy vs. Micro-Ultrasound Guided Biopsy
Prostate Cancer
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer
Recruiting
Rehabilitation and Sex Therapy to Optimize Recovery After Prostate Cancer Treatment
Prostate Cancer, Urinary Incontinence
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Laurence Klotz, MD principal investigator
Sunnybrook Health Sciences Centre
22 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Microultrasonography Targeted Biopsy and MRI Targeted Biopsy in people with Prostate Cancer, run by Sunnybrook Health Sciences Centre at 22 sites in 8 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 sites in United States, Canada, Germany, Spain, France and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Nov 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in Detection of Gleason Grade Group 2 or Higher Cancers Using Microultrasonography Plus Systematic Biopsy vs mpMRI/Conventional Ultrasonography Plus Systematic Biopsy (time frame: Post biopsy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05220501, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Nov 2025.