Optimization of Prostate Biopsy - Micro-Ultrasound Versus MRI
NCT ID: NCT05220501
Last Updated: 2025-11-10
Study Results
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View full resultsBasic Information
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COMPLETED
NA
804 participants
INTERVENTIONAL
2021-12-15
2024-09-06
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
DIAGNOSTIC
NONE
Study Groups
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Microultrasonography only
Subjects will undergo biopsy using micro-ultrasound only.
Microultrasonography Targeted Biopsy
All subjects will be biopsied no matter their arm randomization. In this group, MicroUS targets will be identified and sampled.
Microultrasonography + MRI
Subjects will undergo fusion biopsy using mpMRI and micro-ultrasound
Microultrasonography Targeted Biopsy
All subjects will be biopsied no matter their arm randomization. In this group, MicroUS targets will be identified and sampled.
MRI Targeted Biopsy
All subjects will be biopsied no matter their arm randomization. In this group, mpMRI targets will be identified and sampled.
MRI + Conventional Ultrasonography
Subjects will undergo biopsy using mpMRI fused with regular ultrasound
MRI Targeted Biopsy
All subjects will be biopsied no matter their arm randomization. In this group, mpMRI targets will be identified and sampled.
Interventions
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Microultrasonography Targeted Biopsy
All subjects will be biopsied no matter their arm randomization. In this group, MicroUS targets will be identified and sampled.
MRI Targeted Biopsy
All subjects will be biopsied no matter their arm randomization. In this group, mpMRI targets will be identified and sampled.
Eligibility Criteria
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Inclusion Criteria
* 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 genitourinary cancer, including prostate cancer
* Contraindications to biopsy
* Contraindications to mpMRI
18 Years
MALE
Yes
Sponsors
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Exact Imaging
INDUSTRY
Sunnybrook Health Sciences Centre
OTHER
Responsible Party
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Dr. Laurence Klotz
Affiliate Scientist
Principal Investigators
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Laurence Klotz, MD
Role: PRINCIPAL_INVESTIGATOR
Sunnybrook Health Sciences Centre
Locations
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UCLA
Los Angeles, California, United States
Yale University
New Haven, Connecticut, United States
University of Florida Health
Gainsville, Florida, United States
Johns Hopkins
Baltimore, Maryland, 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
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada
University Health Network - Princess Margaret Hospital
Toronto, Ontario, Canada
Hôpital Maisonneuve-Rosemont
Montreal, Quebec, Canada
Hôpital du Sacré-Cœur de Montréal
Montreal, Quebec, Canada
Centre Hospitàlier Martigues, Hôpitaux de Provence
Martigues, , France
L'Institut Mutualiste Montsouris
Paris, , France
University of Brandenburg
Brandenburg, Brandenburg, Germany
University of Magdeburg
Magdeburg, Saxony-Anholt, Germany
ProUro
Berlin, , Germany
University of Tuebingen
Tübingen, , Germany
Humanitas
Milan, , Italy
Urologica Clinica Bilbao
Bilbao, , Spain
Madrid ROC
Madrid, , Spain
ICUA Madrid
Madrid, , Spain
Countries
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References
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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.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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EVU-2021-001
Identifier Type: -
Identifier Source: org_study_id