Jama OncologyPub Date : 2026-08-01DOI: 10.1001/jamaoncol.2026.2245
Zhihao Lei
{"title":"Notice of Retraction: Lei Z. Rethinking End Points in Modern Oncology Trials-Beyond the P Value. JAMA Oncol. 2025;11(12):1553-1554.","authors":"Zhihao Lei","doi":"10.1001/jamaoncol.2026.2245","DOIUrl":"10.1001/jamaoncol.2026.2245","url":null,"abstract":"","PeriodicalId":48661,"journal":{"name":"Jama Oncology","volume":" ","pages":"895"},"PeriodicalIF":20.1,"publicationDate":"2026-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148228788","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Jama OncologyPub Date : 2026-08-01DOI: 10.1001/jamaoncol.2026.1577
Jules Lansu, Judith V M G Bovée, Pètra M Braam, Aisha B Miah, Øyvind S Bruland, Elizabeth H Baldini, Astrid N Scholten, Olga Hamming-Vrieze, Jolien Heukelom, Lisette M Wiltink, Florine Foppele, Jan F Ubbels, Vincent van der Noort, Rick L Haas
{"title":"Dose Reduction of Preoperative Radiotherapy in Myxoid Liposarcoma: The Phase 2 DOREMY Nonrandomized Clinical Trial.","authors":"Jules Lansu, Judith V M G Bovée, Pètra M Braam, Aisha B Miah, Øyvind S Bruland, Elizabeth H Baldini, Astrid N Scholten, Olga Hamming-Vrieze, Jolien Heukelom, Lisette M Wiltink, Florine Foppele, Jan F Ubbels, Vincent van der Noort, Rick L Haas","doi":"10.1001/jamaoncol.2026.1577","DOIUrl":"10.1001/jamaoncol.2026.1577","url":null,"abstract":"<p><strong>Importance: </strong>Prospective data from 2 phase 2 trials showed favorable wound complication rates and promising local control after a reduced preoperative radiotherapy dose for myxoid liposarcoma (MLS). However, long-term follow-up data are currently lacking.</p><p><strong>Objective: </strong>To determine the efficacy and toxicity profile of a reduced preoperative radiotherapy dose in patients with MLS with long-term follow-up.</p><p><strong>Design, setting, and participants: </strong>The Dose Reduction of Preoperative Radiotherapy in Myxoid Liposarcoma (DOREMY) trial is a prospective, single-group, phase 2 nonrandomized clinical trial conducted in 9 tertiary sarcoma centers in Europe and the US. Eligible patients were adults with biopsy-proven and translocation-confirmed localized MLS of the trunk or extremity who were enrolled from November 24, 2010, to May 14, 2020. Data were analyzed from January to December 2025.</p><p><strong>Intervention: </strong>Preoperative radiotherapy to a reduced dose of 36 Gy in once-daily 2-Gy fractions followed by resection.</p><p><strong>Main outcomes and measures: </strong>Long-term local recurrence-free survival, progression-free survival, disease-specific survival, overall survival, and late toxic effects.</p><p><strong>Results: </strong>Ninety patients (mean [SD] age, 47 [13.1] years; 50 [56%] male) were included and followed up for a median (IQR) of 66.4 (48.8-87.5) months. Preoperative radiotherapy was delivered according to protocol in all patients. Surgery was not performed in 3 patients (3%) due to intercurrent metastatic disease. Local recurrence-free survival, progression-free survival, disease-specific survival, and overall survival rates at 5 years were 97.4% (95% CI, 93.9%-100%), 81.0% (95% CI, 72.6%-89.4%), 89.5% (95% CI, 82.6%-96.4%), and 88.5% (95% CI, 81.2%-95.8%), respectively. In total, 18 patients (21%) experienced a wound complication, and 14 (16%) required intervention. Any grade 2 or grade 3 late toxic effects were seen among 13 patients (15%) and 3 patients (3%), respectively.</p><p><strong>Conclusions and relevance: </strong>This long-term analysis of the DOREMY nonrandomized clinical trial demonstrated excellent local control and a favorable toxicity profile following dose reduction of preoperative radiotherapy in patients with MLS. These compelling phase 2 findings support adoption of this regimen as an appropriate treatment option through shared decision-making with the patient, given the impracticality of conducting a phase 3 trial for a rare cancer.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov Identifier: NCT02106312.</p>","PeriodicalId":48661,"journal":{"name":"Jama Oncology","volume":" ","pages":"863-867"},"PeriodicalIF":20.1,"publicationDate":"2026-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13180261/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147949925","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Fovinaciclib for First-Line Therapy of Advanced Breast Cancer: A Randomized Clinical Trial.","authors":"Peng Yuan, Yunjiang Liu, Wei Li, Huiping Li, Zhongsheng Tong, Jing Cheng, Mingjuan Zhang, Jinlu Shan, Jincai Zhong, Tienan Yi, Jian Liu, Huihui Li, Zhen Huang, Jinsheng Wu, Sijuan Ding, Liang Li, Hong Zong, Hongyan Jia, Shusen Wang, Kun Wang, Hongqiang Guo, Lixia Ma, Zhong Ouyang, Hongtao Li, Tao Sun, Ping Lu, Xiaoran Yang, Xingli Wang, Yuhui Peng, Lize Li, Binghe Xu","doi":"10.1001/jamaoncol.2026.1938","DOIUrl":"10.1001/jamaoncol.2026.1938","url":null,"abstract":"<p><strong>Importance: </strong>Approximately 70% of patients with breast cancer (BC) have hormone receptor-positive, human epidermal growth factor receptor 2 (ERBB2; formerly HER2)-negative disease.</p><p><strong>Objective: </strong>To evaluate the efficacy and safety of fovinaciclib plus an aromatase inhibitor as first-line treatment for hormone receptor-positive, ERBB2-negative advanced BC.</p><p><strong>Design, setting, and participants: </strong>This double-blind, phase 3 randomized clinical trial enrolled patients from March 2, 2022, to June 28, 2023, from 63 centers in China. Eligible patients were adult women with hormone receptor-positive, ERBB2-negative advanced BC and no history of systemic therapy for advanced disease. The data cutoff date was June 25, 2024. Data were analyzed from September to October 2024.</p><p><strong>Intervention: </strong>Patients were randomized (1:1) to receive fovinaciclib, 200 mg (orally once daily on days 1 to 21), or placebo plus letrozole, 2.5 mg, or anastrozole, 1 mg (orally once daily on days 1 to 28), in 28-day cycles. Premenopausal or perimenopausal patients also received goserelin, 3.6 mg (subcutaneously on day 1).</p><p><strong>Main outcomes and measures: </strong>The primary end point was progression-free survival (PFS) per blinded independent central review (BICR). Secondary end points included other efficacy end points and safety. Exploratory end points included overall survival (OS) and quality of life.</p><p><strong>Results: </strong>Of 417 randomized female patients, the median (range) age was 57.0 (32-84) years. A total of 208 were randomized to the fovinaciclib arm and 209 to the placebo arm. At prespecified interim analysis (median [range] follow-up, 16.6 [0.3-27.8] months), a significantly prolonged median PFS was observed with fovinaciclib compared with placebo (not reached vs 20.2 months [95% CI, 16.4 months to not evaluable]; hazard ratio, 0.55; 95% CI, 0.38-0.77; 1-sided P < .001) per BICR assessments. Consistent PFS benefit was observed in most patient subgroups. Fovinaciclib was also favored across secondary efficacy end points. OS data were immature, with only 40 events (9.6%). The most common treatment-emergent adverse events were hematologic toxic effects, none of which led to serious adverse events or study drug discontinuation. Incidence of discontinuation due to treatment-emergent adverse events was only 1.4% in both arms (3 of 208 receiving fovinaciclib and 3 of 209 receiving placebo). Longitudinal changes in global health status, function domains, and symptom domains of European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 were similar between the 2 arms.</p><p><strong>Conclusions and relevance: </strong>In this randomized clinical trial, adding fovinaciclib to first-line aromatase inhibitor conferred significant and clinically meaningful PFS benefit and consistent improvements in other efficacy outcomes, along with manageable safety","PeriodicalId":48661,"journal":{"name":"Jama Oncology","volume":" ","pages":"855-862"},"PeriodicalIF":20.1,"publicationDate":"2026-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13227336/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148145173","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Jama OncologyPub Date : 2026-08-01DOI: 10.1001/jamaoncol.2026.2091
Yiwey Shieh, Rachel S Heise, Lisa Madlensky, Leah P Sabacan, Irene A Soto, Allison S Fiscalini, Katherine Ross, Deborah Goodman, Amie Blanco, Susie Brain, Diane Marie Heditsian, Jackelyn Moya, Kirkpatrick B Fergus, Olufunmilayo I Olopade, Maren T Scheuner, Martin Eklund, Elad Ziv, Jeffrey A Tice, Laura van 't Veer, Laura J Esserman
{"title":"Impact of Population-Based Pathogenic Variant Testing on Risk-Based Breast Screening Recommendations: A Secondary Analysis of the WISDOM Study.","authors":"Yiwey Shieh, Rachel S Heise, Lisa Madlensky, Leah P Sabacan, Irene A Soto, Allison S Fiscalini, Katherine Ross, Deborah Goodman, Amie Blanco, Susie Brain, Diane Marie Heditsian, Jackelyn Moya, Kirkpatrick B Fergus, Olufunmilayo I Olopade, Maren T Scheuner, Martin Eklund, Elad Ziv, Jeffrey A Tice, Laura van 't Veer, Laura J Esserman","doi":"10.1001/jamaoncol.2026.2091","DOIUrl":"10.1001/jamaoncol.2026.2091","url":null,"abstract":"<p><strong>Importance: </strong>Risk-based breast cancer screening has emerged as a viable alternative to annual mammography. To guide implementation, knowledge is needed on the contribution of testing for pathogenic variants (PVs) beyond clinical risk factors and common genetic variants for population-based risk stratification.</p><p><strong>Objective: </strong>To evaluate how many PV carriers in a risk-based breast cancer screening trial would have been recommended for high-risk screening based on clinical risk or clinical plus polygenic risk.</p><p><strong>Design, setting, and participants: </strong>This cohort study used retrospective data from the WISDOM Study, a national clinical trial of risk-based vs annual breast cancer screening, to compare screening assignments informed by PV status vs those based on a clinical risk model alone or a clinical risk model combined with a polygenic risk score. WISDOM participants aged 40 to 74 years who tested positive for a PV as part of risk-based screening were included. Data were collected from September 2016 to February 2023, with follow-up to September 2025. Data were analyzed from January to May 2026.</p><p><strong>Main outcomes and measures: </strong>Concordance between actual (considering participants' PV status) and hypothetical screening assignments based on a clinical (Breast Cancer Surveillance Consortium) risk model or a clinical model plus polygenic risk score.</p><p><strong>Results: </strong>Of 712 included women with a PV, the median (IQR) age was 53 (46-62) years. A total of 232 PVs (33%) were high penetrance, 278 (39%) were moderate penetrance, and 202 (28%) were CHEK2 low penetrance. There was little overlap between actual screening assignments based on PV status and hypothetical assignments based on a clinical model plus polygenic risk score. Among high-penetrance PV carriers (a group recommended high-risk screening with magnetic resonance imaging alternating with mammography every 6 months), 2 of 232 (0.9%) would have received the same screening assignment based on clinical plus polygenic risk. Overall, 178 of 279 PV carriers aged 40 to 49 years (63.8%) would have otherwise been recommended to defer screening until age 50 years based on clinical plus polygenic risk, whereas 385 of 433 carriers aged 50 to 74 years (88.9%) would have been recommended biennial mammography. Results were similar when comparing assignments based on a clinical model alone.</p><p><strong>Conclusions and relevance: </strong>In this cohort study, most participants with PVs in breast cancer genes would not have been recommended for high-risk screening based on their clinical or clinical plus polygenic risk. PV testing therefore may identify different subsets of high-risk women than clinical risk factors and polygenic risk scores. These findings highlight the importance of population-based PV testing in risk-based screening.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov Identifier: NCT02620852.</p","PeriodicalId":48661,"journal":{"name":"Jama Oncology","volume":" ","pages":"875-880"},"PeriodicalIF":20.1,"publicationDate":"2026-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13224042/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148101975","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Jama OncologyPub Date : 2026-08-01DOI: 10.1001/jamaoncol.2026.2264
{"title":"Error in Open Access License.","authors":"","doi":"10.1001/jamaoncol.2026.2264","DOIUrl":"10.1001/jamaoncol.2026.2264","url":null,"abstract":"","PeriodicalId":48661,"journal":{"name":"Jama Oncology","volume":" ","pages":"895"},"PeriodicalIF":20.1,"publicationDate":"2026-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13280753/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148273591","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"First-Line Serplulimab in Extensive-Stage Small Cell Lung Cancer: Secondary Analysis of the ASTRUM-005 Phase 3 Randomized Clinical Trial.","authors":"Jingjing Liu, Liang Han, Lin Wu, Jun Chen, Hongmei Sun, Guilan Wen, Yinghua Ji, Jianhua Shi, Zhijie Pan, Jinsheng Shi, Xicheng Wang, Yuansong Bai, Yueyin Pan, Xuhong Min, Maksym Viguro, Xingya Li, Yanqiu Zhao, Junquan Yang, Tamta Makharadze, Ekaterine Arkania, Haoyu Yu, Jing Li, Xinyi Yang, Qingyu Wang, Jun Zhu","doi":"10.1001/jamaoncol.2026.1645","DOIUrl":"10.1001/jamaoncol.2026.1645","url":null,"abstract":"<p><strong>Importance: </strong>The ASTRUM-005 phase 3 randomized clinical trial showed substantial survival benefit from adding serplulimab to chemotherapy for previously untreated extensive-stage small cell lung cancer (ES-SCLC). However, the long-term outcomes are unclear.</p><p><strong>Objective: </strong>To investigate the efficacy, safety, patient-reported outcomes (PROs), and exploratory biomarker findings from ASTRUM-005 at an extended follow-up.</p><p><strong>Design, setting, and participants: </strong>This international, double-blind, phase 3 randomized clinical trial enrolled patients from September 12, 2019, to April 27, 2021 in China, Russia, Ukraine, Poland, Turkey, and Georgia. Eligible patients had histologically or cytologically confirmed ES-SCLC with no prior systemic therapy. Patients were followed up through May 7, 2024, and the data analysis of this prespecified, secondary analysis lasted from August to September 2024. The median follow-up duration was 42.4 months (range, 0.2-55.2).</p><p><strong>Exposures: </strong>Patients were randomized in a 2:1 ratio to receive intravenous serplulimab (4.5 mg/kg; serplulimab group) or placebo (placebo group), which was combined with up to 4 cycles of carboplatin and etoposide every 3 weeks.</p><p><strong>Main outcomes and measures: </strong>The primary end point was overall survival (OS). Secondary end points included other efficacy end points, safety, and PROs.</p><p><strong>Results: </strong>A total of 585 patients (median [range] age was 63 [28-76] years in the serplulimab group and 62 [31-83] years in the placebo group) with previously untreated ES-SCLC, and 389 (66.5%) were randomly assigned to the serplulimab group and 196 (33.5%) to the placebo group. Baseline characteristics were balanced across treatment groups. At data cutoff, 280 OS events (72.0%) in the serplulimab group and 166 (84.7%) in the placebo group were observed. Compared with the placebo group, the serplulimab group showed more favorable efficacy (median OS, 15.8 [95% CI, 13.9-17.4] vs 11.1 [95% CI, 10.0-12.4] months; hazard ratio, 0.60; 95% CI, 0.49-0.73; P < .001). The serplulimab group showed improved OS rates at 4 years compared with the placebo group (21.9% vs 7.2%). Grade 3 or higher serplulimab-related or placebo-related treatment-emergent adverse events occurred for 136 (35.0%) and 57 patients (29.1%) in the respective groups. A PRO analysis revealed consistent trends of improved overall health, dyspnea, and pain in both groups and faster recovery from alopecia in the serplulimab group.</p><p><strong>Conclusions and relevance: </strong>This secondary analysis of a randomized clinical trial demonstrated long-term benefit from adding serplulimab to chemotherapy for previously untreated patients with ES-SCLC, supporting this therapy as a first-line standard of care for this patient population.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov Identifier: NCT04063163.</p>","PeriodicalId":48661,"journal":{"name":"Jama Oncology","volume":" ","pages":"810-818"},"PeriodicalIF":20.1,"publicationDate":"2026-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13237708/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148158649","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Jama OncologyPub Date : 2026-08-01DOI: 10.1001/jamaoncol.2026.1915
Hongbo Li
{"title":"Survival in the SONIA Trial.","authors":"Hongbo Li","doi":"10.1001/jamaoncol.2026.1915","DOIUrl":"10.1001/jamaoncol.2026.1915","url":null,"abstract":"","PeriodicalId":48661,"journal":{"name":"Jama Oncology","volume":" ","pages":"893"},"PeriodicalIF":20.1,"publicationDate":"2026-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148273559","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Jama OncologyPub Date : 2026-08-01DOI: 10.1001/jamaoncol.2026.1711
Nikhil Mayor, Alexander Light, Archana Gopalakrishnan, Emma Cullen, Francesca Rawlins, Varsha Sonigra-Patel, Natasha Thorley, Tristan Barrett, Ola Bratt, Tim Dudderidge, Mark Emberton, Francesco Giganti, Aiman Haider, Masoom A Haider, Oliver Hulson, Amish Lakhani, Caroline Moore, Tobias Nordstrom, Anwar R Padhani, Ivo G Schoots, Andrew Smith, Henry Tam, Massimo Valerio, Sadhna Verma, Samuel J Withey, Shonit Punwani, Taimur T Shah, Jan van der Meulen, Hashim U Ahmed
{"title":"Prostate Imaging Standards for Screening Magnetic Resonance Imaging (PRISM): International Consensus Recommendations.","authors":"Nikhil Mayor, Alexander Light, Archana Gopalakrishnan, Emma Cullen, Francesca Rawlins, Varsha Sonigra-Patel, Natasha Thorley, Tristan Barrett, Ola Bratt, Tim Dudderidge, Mark Emberton, Francesco Giganti, Aiman Haider, Masoom A Haider, Oliver Hulson, Amish Lakhani, Caroline Moore, Tobias Nordstrom, Anwar R Padhani, Ivo G Schoots, Andrew Smith, Henry Tam, Massimo Valerio, Sadhna Verma, Samuel J Withey, Shonit Punwani, Taimur T Shah, Jan van der Meulen, Hashim U Ahmed","doi":"10.1001/jamaoncol.2026.1711","DOIUrl":"10.1001/jamaoncol.2026.1711","url":null,"abstract":"<p><strong>Importance: </strong>Magnetic resonance imaging (MRI) is routinely used in prostate cancer diagnosis, but there is uncertainty about its optimal use in population-level screening.</p><p><strong>Objective: </strong>To provide consensus recommendations on the acquisition, interpretation, and reporting of prostate MRI for cancer screening.</p><p><strong>Evidence review: </strong>A systematic review and meta-analysis of randomized clinical trials and prospective cohort studies evaluating MRI for prostate cancer screening was conducted for these international consensus recommendations. A search of PubMed, CENTRAL, Scopus, Web of Science, and ClinicalTrials.gov, citation searching, and consultation with experts was performed in September 2024. Studies performing upfront MRI for the purpose of prostate cancer screening were included.</p><p><strong>Findings: </strong>A total of 6 studies were identified and included 1919 participants, of whom 1426 underwent upfront screening MRI. Most studies used 3.0-T non-contrast-enhanced MRI. The pooled biopsy recommendation rate was 19.2% (95% CI, 11.7-26.7), with grade group (GG) 2 or higher prostate cancer detection of 6.0% (95% CI, 3.1-9.0) and GG1 cancer detection of 1.4% (95% CI, 0.7-2.2). The positive predictive value for GG2 or higher cancer was 36.3% (95% CI, 21.1-51.4). Findings informed a RAND/UCLA Appropriateness Method consensus exercise used to produce the Prostate Imaging Standards for Screening Magnetic Resonance Imaging (PRISM) recommendations. A total of 21 experts (8 urologists, 11 radiologists, and 2 pathologists from 6 countries) were included on the panel. Among 323 consensus statements, 235 (72.8%) reached agreement. If MRI is used in screening, it is recommended for men with an estimated life expectancy greater than 10 years and aged 50 to 70 years or from age 45 years in Black men. Screening MRI should be performed in men after a prostate-specific antigen (PSA) test, but there was no consensus on the optimal PSA threshold. Non-contrast-enhanced MRI with only T2-weighted and diffusion-weighted imaging was considered appropriate, with a maximum acceptable acquisition time of 15 minutes. The stage-gated (2-step) approach to reporting, where all MRI sequences are only revealed (second step) if a concordant focal lesion is identified on axial T2-weighted and high b-value diffusion imaging (first step), was recommended. Repeat screening should be risk stratified according to patient characteristics. Screening MRI should only be performed in accredited centers with radiologists meeting minimum reporting requirements and quality standards.</p><p><strong>Conclusions and relevance: </strong>The PRISM consensus recommendations provide standardized expert guidance on the use of MRI in prostate cancer screening trials and future screening programs, including abbreviated non-contrast-enhanced MRI protocols, recommended screening intervals, stage-gated reporting, and quality assurance standards.<","PeriodicalId":48661,"journal":{"name":"Jama Oncology","volume":" ","pages":"881-889"},"PeriodicalIF":20.1,"publicationDate":"2026-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148220319","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}