{"entity":{"id":"pivot","kind":"trial","name":"PIVOT (Prostate Cancer Intervention Versus Observation Trial)","aka":["PIVOT","Prostate Cancer Intervention Versus Observation Trial","CSP #407"],"tldr":"In men whose prostate cancer was found by a blood test, having the operation did not clearly help them live longer, and it left many more of them incontinent or unable to get an erection.","summary":"PIVOT randomised 731 men with localised prostate cancer, most of it detected by PSA testing, to radical prostatectomy or observation between November 1994 and January 2002, and followed them through August 2014.\n\nOver 19.5 years of follow-up (median 12.7 years), 223 of 364 men (61.3 percent) assigned surgery and 245 of 367 (66.8 percent) assigned observation died: absolute difference 5.5 percentage points (95 percent confidence interval -1.5 to 12.4), hazard ratio 0.84 (0.70 to 1.01), p=0.06. Death attributed to prostate cancer or its treatment occurred in 27 men (7.4 percent) after surgery and 42 (11.4 percent) under observation: absolute difference 4.0 percentage points (-0.2 to 8.3), hazard ratio 0.63 (0.39 to 1.02), p=0.06. Neither reached significance.\n\nThe subgroup signal was in intermediate-risk disease, where surgery was associated with an absolute reduction in all-cause mortality of 14.5 percentage points (2.8 to 25.6), against 0.7 points (-10.5 to 11.8) in low-risk and 2.3 points (-11.5 to 16.1) in high-risk disease (p=0.08 for interaction).\n\nWhat surgery reliably did was reduce treatment for progression, by 26.2 percentage points (19.0 to 32.9), almost all of it for asymptomatic local or PSA progression. What it reliably cost was continence and erections: urinary incontinence and erectile and sexual dysfunction were each more frequent after surgery through 10 years, and limitations in activities of daily living were greater through 2 years.","status":"mixed","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT00007644","url":"https://clinicaltrials.gov/study/NCT00007644"},{"label":"PIVOT extended follow-up (New England Journal of Medicine 2017)","url":"https://doi.org/10.1056/NEJMoa1615869"}],"tags":[],"related":[],"cancers":["prostate","prostate-low-risk","prostate-intermediate-risk"],"sections":[],"technologies":["robotic-surgery","active-surveillance"],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":["prostatectomy","active-surveillance-term","psa","qol-pro"],"trials":["spcg-4","protect"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT00007644","phase":"3","setting":"Localised prostate cancer, largely detected by PSA testing, in United States veterans: radical prostatectomy versus observation, with all-cause mortality as the primary outcome and prostate cancer mortality as the main secondary outcome, followed for nearly 20 years","sponsor":"United States Department of Veterans Affairs Cooperative Studies Program and the National Cancer Institute","result":"All-cause mortality 61.3 against 66.8 percent (hazard ratio 0.84, 95 percent confidence interval 0.70 to 1.01, p=0.06) and prostate cancer mortality 7.4 against 11.4 percent (0.63, 0.39 to 1.02, p=0.06); neither significant. Incontinence and erectile dysfunction were greater after surgery through 10 years.","yearReported":2017,"enrolled":731,"enrolledBasis":"randomised","enrolledNote":"731 men were randomised between November 1994 and January 2002; the ClinicalTrials.gov record for NCT00007644 gives the planned target rather than the analysed population.","outcomes":[{"endpoint":"Death from any cause (median 12.7 years)","primary":true,"unit":"%","arms":[{"name":"Radical prostatectomy","n":364,"value":61.3},{"name":"Observation","n":367,"value":66.8}],"hr":0.84,"ci":[0.7,1.01],"p":"0.06","source":"https://doi.org/10.1056/NEJMoa1615869"},{"endpoint":"Death from prostate cancer or its treatment","unit":"%","arms":[{"name":"Radical prostatectomy","n":364,"value":7.4},{"name":"Observation","n":367,"value":11.4}],"hr":0.63,"ci":[0.39,1.02],"p":"0.06","source":"https://doi.org/10.1056/NEJMoa1615869"}],"replication":"Consistent with ProtecT, which found prostate cancer mortality of 3.1, 2.2 and 2.9 percent at 15 years across monitoring, surgery and radiotherapy in a screen-detected population; SPCG-4, in clinically detected disease, found a clear survival benefit for surgery."},"route":"/trials/pivot/","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/"},{"id":"prostate","kind":"cancer","name":"Prostate cancer","route":"/cancers/prostate/"}],"technology":[{"id":"active-surveillance","kind":"technology","name":"Active surveillance","route":"/technologies/active-surveillance/"},{"id":"robotic-surgery","kind":"technology","name":"Robotic & minimally invasive surgery","route":"/technologies/robotic-surgery/"}],"term":[{"id":"active-surveillance-term","kind":"term","name":"Active surveillance and observation","route":"/terms/active-surveillance-term/"},{"id":"prostate-treatment-choice-localised","kind":"term","name":"Choosing treatment for localised prostate cancer: what each option costs","route":"/terms/prostate-treatment-choice-localised/"},{"id":"psa","kind":"term","name":"PSA (prostate-specific antigen)","route":"/terms/psa/"},{"id":"qol-pro","kind":"term","name":"Quality of life and patient-reported outcomes (QoL, PRO)","route":"/terms/qol-pro/"},{"id":"prostatectomy","kind":"term","name":"Radical prostatectomy","route":"/terms/prostatectomy/"}],"trial":[{"id":"protect","kind":"trial","name":"ProtecT","route":"/trials/protect/"},{"id":"spcg-4","kind":"trial","name":"SPCG-4 (Scandinavian Prostate Cancer Group Study 4)","route":"/trials/spcg-4/"}]}}