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| Name | Class |
|---|---|
| Exact Imaging | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Microultrasonography only | Active Comparator | Subjects will undergo biopsy using micro-ultrasound only. |
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| Microultrasonography + MRI | Active Comparator | Subjects will undergo fusion biopsy using mpMRI and micro-ultrasound |
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| MRI + Conventional Ultrasonography | Active Comparator | Subjects will undergo biopsy using mpMRI fused with regular ultrasound |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
Participants need to have a prostate and have been referred to a urologist
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| Name | Affiliation | Role |
|---|---|---|
| Laurence Klotz, MD | Sunnybrook Health Sciences Centre | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCLA | Los Angeles | California | 90095 | United States | ||
| Yale University |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40121537 | Background | 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. |
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Contractual limitations
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Assignment done at point of enrollment
Enrollment opened Dec 2021. Study closed September 6, 2024 after interim analysis endpoints were met for primary outcome. 804 participants recruited, 802 patients randomized. 2 participants withdrew consent prior to randomization. 678 participants were biopsied from 20 centres (hospital and clinics).
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| ID | Title | Description |
|---|---|---|
| FG000 | Microultrasonography | Participants received microultrasonography-guided targeted biopsy and systematic sampling |
| FG001 | Microultrasonography/MRI | Participants received microultrasonography/mpMRI-fusion guided targeted biopsy and systematic sampling |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 26, 2023 |
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All three arms will be active at the same time and subjects will be randomized to one arm.
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| 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. |
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| New Haven |
| Connecticut |
| 06511 |
| United States |
| University of Florida Health | Gainsville | Florida | 32611 | United States |
| Johns Hopkins | Baltimore | Maryland | 21205 | United States |
| Carolina Urologic Research Center | Myrtle Beach | South Carolina | 29572 | United States |
| Ordensklinikum Elisabethinen | Linz | Austria |
| Hopital Delta | Brussels | Belgium |
| University of Alberta | Edmonton | Alberta | T6G1Z1 | Canada |
| Sunnybrook Health Sciences Centre | Toronto | Ontario | M4N3M5 | Canada |
| University Health Network - Princess Margaret Hospital | Toronto | Ontario | M5G 2C4 | Canada |
| Hôpital Maisonneuve-Rosemont | Montreal | Quebec | H1T 2M4 | Canada |
| Hôpital du Sacré-Cœur de Montréal | Montreal | Quebec | H4J 1C5 | Canada |
| Centre Hospitàlier Martigues, Hôpitaux de Provence | Martigues | France |
| L'Institut Mutualiste Montsouris | Paris | France |
| University of Brandenburg | Brandenburg an der Havel | Brandenburg | Germany |
| University of Magdeburg | Magdeburg | Saxony-Anholt | 39120 | Germany |
| ProUro | Berlin | Germany |
| University of Tuebingen | Tübingen | Germany |
| Humanitas | Milan | Italy |
| Urologica Clinica Bilbao | Bilbao | Spain |
| Madrid ROC | Madrid | 28010 | Spain |
| ICUA Madrid | Madrid | Spain |
| FG002 | MRI/conventional ultrasonography | Participants received mpMRI/conventional ultrasonography guided targeted biopsy and systematic sampling |
| COMPLETED |
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| NOT COMPLETED |
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678 participants were randomized and received intervention at the time of interim analysis and study close. 804 participants were enrolled, 2 withdrew prior to randomization leavin
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| ID | Title | Description |
|---|---|---|
| BG000 | Microultrasonography | Participants received microultrasonography-guided targeted biopsy and systematic sampling |
| BG001 | Microultrasonography/MRI | Participants received microultrasonography/MRI-fusion guided targeted biopsy and systematic sampling |
| BG002 | MRI/Conventional Ultrasonography | Participants received MRI/conventional ultrasonography guided targeted biopsy and systematic sampling |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Male participants greater than or equal to 18 years of age | Count of Participants | Participants |
| |||||||||||||||
| Sex: Female, Male | Study only applicable to those at risk for prostate cancer | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| PSA (Prostate Specific Antigen) | PSA (Prostate Specific Antigen) at time of enrollment | Median | Inter-Quartile Range | ng/ml |
| ||||||||||||||
| Digital Rectal Exam (DRE) | Count of participants where DRE was suspicous at the time of enrollment | Count of Participants | Participants |
| |||||||||||||||
| Positive family history for prostate cancer | Positive family history for prostate cancer at the time of enrollment | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Secondary | 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. | Posted | Count of Participants | Participants | Immediately after biopsy |
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| Primary | 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. | As per protocol, the rate of clinically significant prostate cancer found, was compared between participants who underwent microultrasonography (57 of 121 from microultrasonography group and 103 of 226 from the MRI blinded portion of the microultrasonography/mpMRI group) from those participants who underwent mpMRI/conventional ultrasonography-guided biopsy. | Posted | Count of Participants | Participants | Post biopsy |
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7-days post biopsy
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Microultrasonography | Participants received microultrasonography-guided targeted biopsy and systematic sampling | 0 | 121 | 0 | 121 | 0 | 121 |
| EG001 | Microultrasonography/MRI | Participants received microultrasonography-guided targeted biopsy and systematic sampling | 0 | 226 | 0 | 226 | 1 | 226 |
| EG002 | MRI/conventional ultrasonography | Participants received MRI/conventional ultrasonography guided targeted biopsy and systematic sampling | 0 | 331 | 0 | 331 | 9 | 331 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Infection | Surgical and medical procedures | Non-systematic Assessment |
| ||
| Urinary Tract Disorders | Renal and urinary disorders | Non-systematic Assessment | Hematuria, Increase in LUTS (lower urinary tract symptoms) and urinary retention |
| |
| Skin irritation | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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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).
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Laurence Klotz | Sunnybrook Health Sciences Centre | +1. 416 480 4673 | Laurence.Klotz@sunnybrook.ca |
| Aug 6, 2025 |
| Prot_SAP_001.pdf |
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
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| Between 18 and 65 years |
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| >=65 years |
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| Male |
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| Asian descent |
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| Caucasian descent |
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| Hispanic descent |
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| Not stated/not reported |
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| MRI/Conventional ultrasonography |
mpMRI/conventional ultrasonography-guided biopsy, including targeted and systematic samples from the mpMRI/conventional ultrasonography group |
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