OPTIMUM (micro-US vs. MRI/US)
Trial question
Is micro-ultrasound-guided biopsy noninferior to MRI/conventional ultrasonography fusion-guided biopsy in biopsy-naïve men with clinical suspicion of prostate cancer?
Study design
Multi-center
Open label
RCT
Population
452 male patients.
Inclusion criteria: biopsy-naïve men with clinical suspicion of prostate cancer.
Key exclusion criteria: prior prostate biopsy; genitourinary cancer, including prostate cancer; contraindications to biopsy; contraindications to multiparametric MRI.
Interventions
N=121 micro-ultrasound (subjects will undergo biopsy using micro-ultrasound only).
N=331 MRI/conventional ultrasound (subjects will undergo biopsy using MRI fused with regular ultrasound).
Primary outcome
Detection of Gleason Grade Group ≥ 2 prostate cancer
46.1%
42.6%
46.1 %
34.6 %
23.1 %
11.5 %
0.0 %
Micro-ultrasound
MRI/conventional
ultrasound
Difference not exceeding
non-inferiority
margin ✓
Difference not exceeding non-inferiority margin in detection of Gleason Grade Group ≥ 2 prostate cancer (46.1% vs. 42.6%; AD 3.52%, 95% CI -3.95 to 10.92).
Secondary outcomes
No significant difference in targeted biopsy-only detection rate of grade group ≥ 2 cancer (38% vs. 34%; AD 3.88%, 95% CI -6.12 to 13.89).
No significant difference in detection of Gleason Grade Group ≥ 3 prostate cancer (23% vs. 27%; ARD -3, 95% CI -10 to 3).
No significant difference in detection of benign cancer (39% vs. 42%; ARD -3, 95% CI -11 to 4).
Safety outcomes
No significant difference in adverse events.
Conclusion
In biopsy-naïve men with clinical suspicion of prostate cancer, micro-ultrasound was noninferior to MRI/conventional ultrasound with respect to detection of Gleason Grade Group ≥ 2 prostate cancer.
Reference
Adam Kinnaird, Ferdinand Luger, Hannes Cash et al. Microultrasonography-Guided vs MRI-Guided Biopsy for Prostate Cancer Diagnosis: The OPTIMUM Randomized Clinical Trial. JAMA. 2025 Mar 23. Online ahead of print.
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