{"entity":{"id":"paper-wilt-pivot-prostatectomy-observation-nejm-2017","kind":"paper","name":"PIVOT: follow-up of prostatectomy versus observation for early prostate cancer","aka":["PIVOT","Wilt 2017","Prostate Cancer Intervention Versus Observation Trial"],"tldr":"In men whose prostate cancer was mostly found by a blood test, surgery did not significantly reduce deaths after nearly twenty years. It did cause more incontinence and sexual problems, and it did reduce later treatment for the cancer growing.","summary":"Timothy Wilt and the PIVOT investigators randomised 731 men with localised prostate cancer to radical prostatectomy or observation between November 1994 and January 2002 in the United States Department of Veterans Affairs system, and extended follow-up to August 2014, a median of 12.7 years.\n\nPIVOT is the counterweight to SPCG-4 and it enrolled in the prostate-specific antigen era. Neither all-cause nor prostate-cancer mortality reached significance, both at P equals 0.06, and the subgroup analysis suggested benefit in intermediate-risk disease and none in low-risk disease. The harms are unambiguous: urinary incontinence and erectile and sexual dysfunction were greater with surgery through 10 years. Most of the progression that surgery prevented was asymptomatic, local or biochemical.","asOf":"2026-09-25","links":[{"label":"N Engl J Med 2017","url":"https://doi.org/10.1056/nejmoa1615869"},{"label":"PubMed","url":"https://pubmed.ncbi.nlm.nih.gov/28700844/"},{"label":"ClinicalTrials.gov NCT00007644","url":"https://clinicaltrials.gov/study/NCT00007644"}],"tags":["prostate-evidence"],"related":["paper-bill-axelson-spcg-4-29-year-nejm-2018","paper-protect-15-year-nejm-2023","paper-klotz-active-surveillance-jco-2015","prostate-roadmap"],"cancers":["prostate","prostate-low-risk","prostate-intermediate-risk"],"sections":["surgery","early-detection"],"technologies":["active-surveillance"],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":["prostatectomy","psa","overdiagnosis","quality-of-life","other-cause-mortality","overtreatment"],"trials":[],"people":[],"bottlenecks":["b-overdiagnosis","b-toxicity-qol","b-trial-enrolment"],"keyPapers":[],"journals":["nejm"],"dependsOn":[],"notes":[],"journal":"New England Journal of Medicine","year":2017,"doi":"10.1056/nejmoa1615869","pmid":"28700844","authors":"Wilt TJ, Jones KM, Barry MJ, et al.","paperType":"rct","findings":["Over 19.5 years of follow-up (median 12.7 years), death occurred in 223 of 364 men (61.3 percent) assigned to surgery and 245 of 367 (66.8 percent) assigned to observation: hazard ratio 0.84 (95 percent confidence interval 0.70 to 1.01; P equals 0.06).","Death attributed to prostate cancer or its treatment occurred in 27 men (7.4 percent) assigned to surgery and 42 (11.4 percent) assigned to observation: hazard ratio 0.63 (0.39 to 1.02; P equals 0.06).","Surgery may have been associated with lower all-cause mortality in intermediate-risk disease (absolute difference 14.5 percentage points, 2.8 to 25.6) but not in low-risk (0.7 points, minus 10.5 to 11.8) or high-risk disease (2.3 points, minus 11.5 to 16.1); P equals 0.08 for interaction.","Treatment for disease progression was less frequent with surgery (absolute difference 26.2 percentage points, 19.0 to 32.9), primarily for asymptomatic, local or biochemical progression.","Urinary incontinence and erectile and sexual dysfunction were each greater with surgery than with observation through 10 years."],"whatItMeans":"The trial that made observation a defensible choice for low-risk prostate cancer found by a blood test, and that supplied the number a man needs when weighing surgery: the progression it prevents is mostly progression on a scan or a blood test, and the harms it causes are felt every day.","caveats":["Under-recruited against its own target, which is the main reason two clinically meaningful differences both landed at P equals 0.06 rather than below 0.05.","A Veterans Affairs population with substantial comorbidity, which raises competing mortality and dilutes any cancer-specific benefit.","Observation in PIVOT is not active surveillance: there was no protocol-driven magnetic resonance imaging or repeat biopsy triggering radical treatment."],"changedPractice":true,"participants":731},"route":"/key-papers/paper-wilt-pivot-prostatectomy-observation-nejm-2017/","neighbours":{"paper":[{"id":"paper-klotz-active-surveillance-jco-2015","kind":"paper","name":"Long-term follow-up of a large active surveillance cohort of patients with prostate cancer (Sunnybrook)","route":"/key-papers/paper-klotz-active-surveillance-jco-2015/"},{"id":"paper-protect-nejm-2016","kind":"paper","name":"ProtecT: 10-year outcomes after monitoring, surgery or radiotherapy for localised prostate cancer","route":"/key-papers/paper-protect-nejm-2016/"},{"id":"paper-protect-15-year-nejm-2023","kind":"paper","name":"ProtecT: fifteen-year outcomes after monitoring, surgery or radiotherapy for prostate cancer","route":"/key-papers/paper-protect-15-year-nejm-2023/"},{"id":"paper-bill-axelson-spcg-4-29-year-nejm-2018","kind":"paper","name":"SPCG-4: radical prostatectomy or watchful waiting in prostate cancer, 29-year follow-up","route":"/key-papers/paper-bill-axelson-spcg-4-29-year-nejm-2018/"}],"roadmap":[{"id":"prostate-roadmap","kind":"roadmap","name":"Prostate cancer roadmap: from Huggins and the discovery that a cancer can depend on a hormone, through the PSA epidemic and what it cost, the androgen receptor drugs, the DNA repair subset and PSMA, to a 2032 registry watch","route":"/roadmaps/prostate-roadmap/"}],"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/"},{"id":"prostate","kind":"cancer","name":"Prostate cancer","route":"/cancers/prostate/"}],"section":[{"id":"early-detection","kind":"section","name":"Early Detection & Screening","route":"/fronts/early-detection/"},{"id":"surgery","kind":"section","name":"Surgery & Interventional","route":"/fronts/surgery/"}],"technology":[{"id":"active-surveillance","kind":"technology","name":"Active surveillance","route":"/technologies/active-surveillance/"}],"term":[{"id":"other-cause-mortality","kind":"term","name":"Other-cause mortality","route":"/terms/other-cause-mortality/"},{"id":"overdiagnosis","kind":"term","name":"Overdiagnosis","route":"/terms/overdiagnosis/"},{"id":"overtreatment","kind":"term","name":"Overtreatment","route":"/terms/overtreatment/"},{"id":"psa","kind":"term","name":"PSA (prostate-specific antigen)","route":"/terms/psa/"},{"id":"quality-of-life","kind":"term","name":"Quality of life","route":"/terms/quality-of-life/"},{"id":"prostatectomy","kind":"term","name":"Radical prostatectomy","route":"/terms/prostatectomy/"}],"bottleneck":[{"id":"b-overdiagnosis","kind":"bottleneck","name":"Overdiagnosis and false alarms","route":"/bottlenecks/b-overdiagnosis/"},{"id":"b-toxicity-qol","kind":"bottleneck","name":"Toxicity and quality of life are undervalued","route":"/bottlenecks/b-toxicity-qol/"},{"id":"b-trial-enrolment","kind":"bottleneck","name":"Trials enrol too few, too slowly","route":"/bottlenecks/b-trial-enrolment/"}],"journal":[{"id":"nejm","kind":"journal","name":"New England Journal of Medicine","route":"/journals/nejm/"}]}}