{"entity":{"id":"paper-protect-nejm-2016","kind":"paper","name":"ProtecT: 10-year outcomes after monitoring, surgery or radiotherapy for localised prostate cancer","aka":[],"tldr":"In the only randomised trial to compare active monitoring, surgery and radiotherapy for PSA-detected localised prostate cancer, deaths from prostate cancer were rare and equal at ten years in all three groups, though monitoring led to more metastases and progression.","summary":"Phase 3 trial of 1,643 men with PSA-detected localised prostate cancer randomised to active monitoring, radical prostatectomy or radiotherapy with six months of androgen deprivation.\n\nProstate cancer-specific mortality at ten years was about 1 percent in every group (17 deaths in total), while metastases (6.3 versus 2.4 and 3.0 per 1,000 person-years) and clinical progression were more frequent with monitoring; patient-reported outcomes showed distinct side-effect patterns for each treatment.","asOf":"2026-09-17","links":[{"label":"N Engl J Med 2016","url":"https://doi.org/10.1056/NEJMoa1606220"},{"label":"PubMed","url":"https://pubmed.ncbi.nlm.nih.gov/27626136/"}],"tags":[],"related":[],"cancers":["prostate-intermediate-risk","prostate-low-risk"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":["protect"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":["nejm"],"dependsOn":[],"notes":[],"journal":"New England Journal of Medicine","year":2016,"doi":"10.1056/NEJMoa1606220","pmid":"27626136","authors":"Hamdy FC, Donovan JL, Lane JA, et al.","paperType":"rct","findings":["Prostate cancer-specific mortality about 1 percent at ten years in all groups.","Metastases 6.3 per 1,000 person-years with monitoring vs 2.4 (surgery) and 3.0 (radiotherapy)."],"whatItMeans":"Most men with low- and favourable intermediate-risk prostate cancer can safely choose monitoring, and treatment choice should weigh urinary, sexual and bowel side effects against a small difference in progression.","caveats":["Most men had low-risk disease; about 20 percent were intermediate or high risk.","Active monitoring was less intensive than modern active surveillance with MRI."],"changedPractice":true,"participants":1643},"route":"/key-papers/paper-protect-nejm-2016/","neighbours":{"cancer":[{"id":"prostate-intermediate-risk","kind":"cancer","name":"Localised prostate cancer, intermediate risk","route":"/cancers/prostate-intermediate-risk/"},{"id":"prostate-low-risk","kind":"cancer","name":"Localised prostate cancer, very low and low risk","route":"/cancers/prostate-low-risk/"}],"trial":[{"id":"protect","kind":"trial","name":"ProtecT","route":"/trials/protect/"}],"journal":[{"id":"nejm","kind":"journal","name":"New England Journal of Medicine","route":"/journals/nejm/"}]}}