2025-03-25 イェール大学
<関連情報>
- https://medicine.yale.edu/urology/news-article/breakthrough-study-in-image-guided-prostate-cancer-treatment/
- https://jamanetwork.com/journals/jama/article-abstract/2831985
前立腺癌診断におけるマイクロ超音波ガイド下生検とMRIガイド下生検の比較 OPTIMUMランダム化臨床試験 Microultrasonography-Guided vs MRI-Guided Biopsy for Prostate Cancer Diagnosis The OPTIMUM Randomized Clinical Trial
Adam Kinnaird, MD, PhD; Ferdinand Luger, MD; Hannes Cash, MD; et al
Journal of the American Medical Association Published:March 23, 2025
DOI:10.1001/jama.2025.3579
Key Points
Question Is high-resolution microultrasonography-guided biopsy noninferior to magnetic resonance imaging (MRI) fusion-guided biopsy in the detection of clinically significant prostate cancer?
Findings In this randomized clinical trial that included 678 participants, microultrasonography-guided biopsy was noninferior to MRI fusion-guided biopsy for detection of Gleason Grade Group 2 or higher prostate cancer (difference, 3.52% [95% CI, -3.95% to 10.92%]; noninferiority P < .001).
Meaning Microultrasonography-guided biopsy was noninferior to MRI fusion-guided biopsy and may provide an alternative to MRI for image-guided prostate biopsy.
Abstract
Importance High-resolution microultrasonography-guided biopsy is an alternative to MRI fusion-guided biopsy for prostate cancer diagnosis.
Objective To compare microultrasonography-guided and MRI fusion-guided biopsy.
Design, Setting, and Participants A multicenter, international, open-label, randomized, noninferiority trial of biopsy-naive men from 20 centers (8 countries) with clinical suspicion of prostate cancer (elevated prostate-specific antigen [PSA] and/or abnormal digital rectal examination findings) from December 2021 to September 2024.
Interventions Participants were assigned to receive either microultrasonography-guided biopsy (n = 121), microultrasonography/MRI fusion-guided biopsy (microultrasonography/MRI; n = 226, in which microultrasonography biopsies were performed prior to unblinding the MRI), or MRI/conventional US fusion-guided biopsy (MRI/conventional ultrasonography; n = 331). All participants received synchronous systematic biopsy.
Main Outcomes and Measures The primary outcome was the difference in detection of Gleason Grade Group 2 or higher cancers using microultrasonography plus systematic biopsy vs MRI/conventional ultrasonography plus systematic biopsy. The secondary outcome was the difference in detection of Gleason Grade Group 2 or higher cancers found using microultrasonography/MRI plus systematic biopsy vs MRI/conventional ultrasonography plus systematic biopsy. The noninferiority margin was set at 10%.
Results A total of 802 men underwent randomization and 678 underwent biopsy. Median (IQR) age was 65 (59-70) years and prostate-specific antigen level was 6.9 (5.2-9.8) ng/mL; 83% self-identified as White. Gleason Grade Group 2 or higher cancer was detected in 57 participants (47.1%) in the microultrasonography group, in 141 (42.6%) in the MRI/conventional ultrasonography group, and in 106 (46.9%) in the microultrasonography/MRI group. Microultrasonography-guided biopsy was noninferior to MRI fusion-guided biopsy (difference, 3.52% [95% CI, -3.95% to 10.92%]; noninferiority P < .001). Combined biopsy with microultrasonography/MRI was also noninferior to MRI/conventional ultrasonography software-assisted MRI fusion biopsy using conventional ultrasonography devices (difference, 4.29% [95% CI, -4.06% to 12.63%]; noninferiority P < .001). The rate of Gleason Grade Group 2 or higher cancer diagnosed by targeted biopsy only was 38.0% in the microultrasonography group, 34.1% in the MRI/conventional ultrasonography group, and 40.3% in the microultrasonography/MRI group; these differences were not significant.
Conclusions and Relevance The use of microultrasonography-guided biopsy was noninferior to MRI/conventional ultrasonography fusion-guided biopsy for the detection of Gleason Grade Group 2 or higher prostate cancer in biopsy-naive men. Microultrasonography may provide an alternative to MRI for image-guided prostate biopsy.
Trial Registration ClinicalTrials.gov Identifier: NCT05220501
