TY - JOUR
T1 - Optimization of prostate biopsy - Micro-Ultrasound versus MRI (OPTIMUM)
T2 - 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
AU - Klotz, Laurence
AU - Andriole, Gerald
AU - Cash, Hannes
AU - Cooperberg, Matthew
AU - Crawford, E. David
AU - Emberton, Mark
AU - Gomez-Sancha, Fernando
AU - Klein, Eric
AU - Lughezzani, Giovanni
AU - Marks, Leonard
AU - Montorsi, Francesco
AU - Salomon, Georg
AU - Sanchez-Salas, Rafael
AU - Shore, Neal
AU - Taneja, Samir
N1 - Publisher Copyright:
© 2021
PY - 2022/1
Y1 - 2022/1
N2 - 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.
AB - 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.
KW - Magnetic resonance imaging
KW - Micro-ultrasound
KW - Multiparametric MRI
KW - Prostate cancer
KW - Transrectal ultrasound
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U2 - 10.1016/j.cct.2021.106618
DO - 10.1016/j.cct.2021.106618
M3 - Article
C2 - 34728381
AN - SCOPUS:85121255955
SN - 1551-7144
VL - 112
JO - Contemporary Clinical Trials
JF - Contemporary Clinical Trials
M1 - 106618
ER -