Adam Kinnaird, Ferdinand Luger, Hannes Cash, Sangeet Ghai, L Felipe Urdaneta-Salegui, Christian P Pavlovich, Joseph Brito, Neal D Shore, Julian P Struck, Martin Schostak, Niklas Harland, Moisés Rodriguez-Socarrás, Wayne G Brisbane, Giovanni Lughezzani, Harry Toledano, Mohammed Salah Ouertani, Petr Macek, Christopher Fung, Wendy Tu, Andreas Gusenleitner, Karsten Günzel, Peter F Incze, Arvin K George, José G Pereira, Robert Jansen, Joseph Renzulli, Laurence Klotz
<p><strong>Importance: </strong>High-resolution microultrasonography-guided biopsy is an alternative to MRI fusion-guided biopsy for prostate cancer diagnosis.</p><p><strong>Objective: </strong>To compare microultrasonography-guided and MRI fusion-guided biopsy.</p><p><strong>Design, setting, and participants: </strong>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.</p><p><strong>Interventions: </strong>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.</p><p><strong>Main outcomes and measures: </strong>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%.</p><p><strong>Results: </strong>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.</p><p><strong>Conclusions and relevance: </strong>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
{"title":"Microultrasonography-Guided vs MRI-Guided Biopsy for Prostate Cancer Diagnosis: The OPTIMUM Randomized Clinical Trial.","authors":"Adam Kinnaird, Ferdinand Luger, Hannes Cash, Sangeet Ghai, L Felipe Urdaneta-Salegui, Christian P Pavlovich, Joseph Brito, Neal D Shore, Julian P Struck, Martin Schostak, Niklas Harland, Moisés Rodriguez-Socarrás, Wayne G Brisbane, Giovanni Lughezzani, Harry Toledano, Mohammed Salah Ouertani, Petr Macek, Christopher Fung, Wendy Tu, Andreas Gusenleitner, Karsten Günzel, Peter F Incze, Arvin K George, José G Pereira, Robert Jansen, Joseph Renzulli, Laurence Klotz","doi":"10.1001/jama.2025.3579","DOIUrl":"10.1001/jama.2025.3579","url":null,"abstract":"<p><strong>Importance: </strong>High-resolution microultrasonography-guided biopsy is an alternative to MRI fusion-guided biopsy for prostate cancer diagnosis.</p><p><strong>Objective: </strong>To compare microultrasonography-guided and MRI fusion-guided biopsy.</p><p><strong>Design, setting, and participants: </strong>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.</p><p><strong>Interventions: </strong>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.</p><p><strong>Main outcomes and measures: </strong>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%.</p><p><strong>Results: </strong>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.</p><p><strong>Conclusions and relevance: </strong>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","PeriodicalId":17196,"journal":{"name":"Journal of the American Medical Association","volume":" ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2025-03-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11931425/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143692539","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Rehab.","authors":"Roshni Beeharry","doi":"10.1001/jama.2024.23097","DOIUrl":"10.1001/jama.2024.23097","url":null,"abstract":"","PeriodicalId":17196,"journal":{"name":"Journal of the American Medical Association","volume":" ","pages":"1008"},"PeriodicalIF":0.0,"publicationDate":"2025-03-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143449477","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Can We Omit Surgery for Low-Risk Ductal Carcinoma In Situ of the Breast?","authors":"Seema A Khan, Timothy Whelan","doi":"10.1001/jama.2025.0088","DOIUrl":"10.1001/jama.2025.0088","url":null,"abstract":"","PeriodicalId":17196,"journal":{"name":"Journal of the American Medical Association","volume":" ","pages":"948-949"},"PeriodicalIF":0.0,"publicationDate":"2025-03-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143458511","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Climate Change and Coccidioidomycosis.","authors":"Pamela S Lee, Daniel L Swain, Royce Johnson","doi":"10.1001/jama.2024.27274","DOIUrl":"10.1001/jama.2024.27274","url":null,"abstract":"","PeriodicalId":17196,"journal":{"name":"Journal of the American Medical Association","volume":" ","pages":"997-998"},"PeriodicalIF":0.0,"publicationDate":"2025-03-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143458513","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Incorrect Data in Table.","authors":"","doi":"10.1001/jama.2025.1399","DOIUrl":"10.1001/jama.2025.1399","url":null,"abstract":"","PeriodicalId":17196,"journal":{"name":"Journal of the American Medical Association","volume":" ","pages":"1007"},"PeriodicalIF":0.0,"publicationDate":"2025-03-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11843455/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143458461","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Is It Time to Abandon Surgery for Low-Risk DCIS?","authors":"Monica Morrow, Andrea V Barrio","doi":"10.1001/jama.2024.26723","DOIUrl":"10.1001/jama.2024.26723","url":null,"abstract":"","PeriodicalId":17196,"journal":{"name":"Journal of the American Medical Association","volume":" ","pages":"946-947"},"PeriodicalIF":0.0,"publicationDate":"2025-03-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142813408","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"My Final Respects.","authors":"Faith E Fletcher","doi":"10.1001/jama.2025.0051","DOIUrl":"10.1001/jama.2025.0051","url":null,"abstract":"","PeriodicalId":17196,"journal":{"name":"Journal of the American Medical Association","volume":" ","pages":"941-942"},"PeriodicalIF":0.0,"publicationDate":"2025-03-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143458465","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Where My Hair Went.","authors":"Laura Paul Watson","doi":"10.1001/jama.2024.23341","DOIUrl":"10.1001/jama.2024.23341","url":null,"abstract":"","PeriodicalId":17196,"journal":{"name":"Journal of the American Medical Association","volume":" ","pages":"1009"},"PeriodicalIF":0.0,"publicationDate":"2025-03-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143458420","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Regulation of Artificial Intelligence in Health Care and Biomedicine.","authors":"Nikhil Jaiswal, Konrad Samsel, Leo Anthony Celi","doi":"10.1001/jama.2024.26609","DOIUrl":"10.1001/jama.2024.26609","url":null,"abstract":"","PeriodicalId":17196,"journal":{"name":"Journal of the American Medical Association","volume":" ","pages":"1003"},"PeriodicalIF":0.0,"publicationDate":"2025-03-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143458467","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Chelsea L Shover, Morgan E Godvin, Meghan Appley, Elise M Pyfrom, Fernando Montero Castrillo, Karli Hochstatter, Talia Nadel, Neil Garg, Adam Koncsol, Joseph R Friedman, Caitlin A Molina, Ruby Romero, Brendan Harshberger, Jordan A M Gonzalez, Jordan Spoliansky, Sarah Laurel, Elham Jalayer, Juan Ruelas, John Gonzales, Soma Snakeoil, Sonya Guerra, Oscar Arellano, Candace Winstead, Margaret Rybak, Joanna Champney, Brent Waninger, Rafael Torruella, Edward Sisco
{"title":"UV Stabilizer BTMPS in the Illicit Fentanyl Supply in 9 US Locations.","authors":"Chelsea L Shover, Morgan E Godvin, Meghan Appley, Elise M Pyfrom, Fernando Montero Castrillo, Karli Hochstatter, Talia Nadel, Neil Garg, Adam Koncsol, Joseph R Friedman, Caitlin A Molina, Ruby Romero, Brendan Harshberger, Jordan A M Gonzalez, Jordan Spoliansky, Sarah Laurel, Elham Jalayer, Juan Ruelas, John Gonzales, Soma Snakeoil, Sonya Guerra, Oscar Arellano, Candace Winstead, Margaret Rybak, Joanna Champney, Brent Waninger, Rafael Torruella, Edward Sisco","doi":"10.1001/jama.2024.27550","DOIUrl":"10.1001/jama.2024.27550","url":null,"abstract":"","PeriodicalId":17196,"journal":{"name":"Journal of the American Medical Association","volume":" ","pages":"1000-1003"},"PeriodicalIF":0.0,"publicationDate":"2025-03-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11800118/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143189794","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
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