Optimization of prostate biopsy - Micro-Ultrasound versus MRI (OPTIMUM): A 3-arm randomized controlled trial evaluating the role of 29 MHz micro-ultrasound in guiding prostate biopsy in men with clinical suspicion of prostate cancer.

BACKGROUND

Micro-ultrasound (microUS) is a novel ultrasound-based imaging modality which has demonstrated the ability to visualize prostate cancer. Multiparametric MRI/ultrasound (mpMRI/US) fusion has recognized advantages for the performance of prostate biopsy, however, it encompasses additional cost, time and technical expertise to performing prostate biopsy in comparison to conventional trans-rectal ultrasound biopsy. MicroUS may simplify and optimize this pathway.

METHODS

OPTIMUM is a 3-arm randomized controlled trial comparing microUS guided biopsy with MRI/US fusion and MRI/MicroUS "contour-less" fusion. This trial will investigate whether microUS alone, or in combination with mpMRI, provides effective guidance during prostate biopsy for the detection of clinically significant prostate cancer (csPCa) for biopsy naïve subjects. 1200 subjects will be randomized. The economic impact will be evaluated.

RESULTS

The rate of csPCa (defined as Grade Group 2 and above) in each arm will be compared. The primary hypothesis is non-inferiority of csPCa rate between the MRI/US fusion arm and the microUS-only arm (including the blinded microUS-only portion of the MRI/MicroUS arm). As a secondary objective, the csPCa rate between MRI/MicroUS fusion and MRI/US fusion arms will also be compared. Other secondary objectives include the increase in rate of patients diagnosed with csPCa due to each type of sample (mpMRI targeted, microUS targeted, systematic), the negative predictive value of each imaging modality, and a health economic analysis of the procedures in each arm.

CONCLUSIONS

OPTIMUM will determine whether microUS can be used as an alternative to MRI/US fusion biopsy. The trial will also evaluate the efficacy of the simplified "contour-less" MRI/MicroUS fusion procedure. The adoption of the microUS technique will increase the proportion of men who can benefit from modern imaging-centric diagnostic strategies, and may help reduce variability, complexity, waiting time and cost within the diagnostic pathway.