Prostate Cancer
Conditions
Keywords
prostate, prostate biopsy, micro-ultrasound
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.
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.
Interventions
DIAGNOSTIC_TESTMicroultrasonography Targeted Biopsy
All subjects will be biopsied no matter their arm randomization. In this group, MicroUS targets will be identified and sampled.
DIAGNOSTIC_TESTMRI Targeted Biopsy
All subjects will be biopsied no matter their arm randomization. In this group, mpMRI targets will be identified and sampled.
Sponsors
Exact Imaging
Sunnybrook Health Sciences Centre
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Intervention model description
All three arms will be active at the same time and subjects will be randomized to one arm.
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Difference in Detection of Gleason Grade Group 2 or Higher Cancers Using Microultrasonography Plus Systematic Biopsy vs mpMRI/Conventional Ultrasonography Plus Systematic Biopsy | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Difference in csPCa Rate Between MicroUS/MRI- Guided Fusion Biopsy and MRI/Conventional Ultrasonography Guided Fusion Biopsy | Immediately after biopsy | The secondary outcome, detection of clinically significant prostate cancer by combined microultrasonography/mpMRI-guided fusion biopsy vs mpMRI/conventional ultrasonography-guided fusion biopsy. |
Countries
Austria, Belgium, Canada, France, Germany, Italy, Spain, United States
Participant flow
Recruitment details
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).
Pre-assignment details
Assignment done at point of enrollment
Participants by arm
| Arm | Count |
|---|---|
| Microultrasonography Participants received microultrasonography-guided targeted biopsy and systematic sampling | 121 |
| Microultrasonography/MRI Participants received microultrasonography/MRI-fusion guided targeted biopsy and systematic sampling | 226 |
| MRI/Conventional Ultrasonography Participants received MRI/conventional ultrasonography guided targeted biopsy and systematic sampling | 331 |
| Total | 678 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Awaiting biopsy at time of interim analysis. Study closed. Primary endpoint met | 5 | 16 | 39 |
| Overall Study | Withdrawal by Subject | 11 | 21 | 32 |
Baseline characteristics
| Characteristic | Microultrasonography | Microultrasonography/MRI | MRI/Conventional Ultrasonography | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 66 Participants | 126 Participants | 170 Participants | 362 Participants |
| Age, Categorical Between 18 and 65 years | 55 Participants | 100 Participants | 161 Participants | 316 Participants |
| Digital Rectal Exam (DRE) | 25 Participants | 48 Participants | 81 Participants | 154 Participants |
| Positive family history for prostate cancer | 29 Participants | 55 Participants | 78 Participants | 162 Participants |
| PSA (Prostate Specific Antigen) | 7.2 ng/ml | 7.0 ng/ml | 6.7 ng/ml | 6.8 ng/ml |
| Race/Ethnicity, Customized African descent | 3 Participants | 8 Participants | 16 Participants | 27 Participants |
| Race/Ethnicity, Customized Asian descent | 3 Participants | 9 Participants | 13 Participants | 25 Participants |
| Race/Ethnicity, Customized Caucasian descent | 105 Participants | 180 Participants | 277 Participants | 562 Participants |
| Race/Ethnicity, Customized Hispanic descent | 9 Participants | 20 Participants | 15 Participants | 44 Participants |
| Race/Ethnicity, Customized Not stated/not reported | 1 Participants | 9 Participants | 10 Participants | 20 Participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 121 Participants | 226 Participants | 331 Participants | 678 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 121 | 0 / 226 | 0 / 331 |
| other Total, other adverse events | 0 / 121 | 1 / 226 | 9 / 331 |
| serious Total, serious adverse events | 0 / 121 | 0 / 226 | 0 / 331 |
Outcome results
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.
Time frame: Post biopsy
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Microultrasonography/MRI | Difference in Detection of Gleason Grade Group 2 or Higher Cancers Using Microultrasonography Plus Systematic Biopsy vs mpMRI/Conventional Ultrasonography Plus Systematic Biopsy | 160 Participants |
| MRI/ conventional ultrasonography | Difference in Detection of Gleason Grade Group 2 or Higher Cancers Using Microultrasonography Plus Systematic Biopsy vs mpMRI/Conventional Ultrasonography Plus Systematic Biopsy | 141 Participants |
p-value: <0.001Jeffreys interval
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.
Time frame: Immediately after biopsy
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Microultrasonography/MRI | Difference in csPCa Rate Between MicroUS/MRI- Guided Fusion Biopsy and MRI/Conventional Ultrasonography Guided Fusion Biopsy | 106 Participants |
| MRI/ conventional ultrasonography | Difference in csPCa Rate Between MicroUS/MRI- Guided Fusion Biopsy and MRI/Conventional Ultrasonography Guided Fusion Biopsy | 141 Participants |