At a glance
ClinicalIndex Comparison RecordN/ACompleted· 804 enrolled
Drug / intervention
Microultrasonography Targeted Biopsy +1 moreother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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.
In Brief
A clinical study evaluating Microultrasonography Targeted Biopsy and MRI Targeted Biopsy for Prostate Cancer. Completed, enrolled 804 participants across 22 sites in 8 countries.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsProstate Cancer
CountriesAustria, Belgium, Canada, France, Germany, Italy, Spain, United States
CollaboratorsExact Imaging
Timeline
N/ACompletedFinished
20222023202420252026
Enrollment StartDec 2021
First PostedFeb 2022
Primary CompletionSep 2024
TodayJul 2026
First PostedFeb 2, 2022
Enrollment StartDec 15, 2021
Primary CompletionSep 6, 2024
TodayJul 2, 2026
Enrollment to primary: 2.7 yearsPosted 4.4 years ago
Interventions
Microultrasonography Targeted Biopsyother
All subjects will be biopsied no matter their arm randomization. In this group, MicroUS targets will be identified and sampled.
MRI Targeted Biopsyother
All subjects will be biopsied no matter their arm randomization. In this group, mpMRI targets will be identified and sampled.