{"entity":{"id":"protect","kind":"trial","name":"ProtecT","aka":[],"tldr":"Showed that men with screen-detected prostate cancer die of it rarely, whether monitored or treated, establishing active surveillance.","summary":"ProtecT, trial NCT02044172 sponsored by the UK National Institute for Health Research through Oxford and Bristol, showed that men with PSA-detected localised prostate cancer rarely die of it over fifteen years whether monitored, operated on or irradiated, and it established active surveillance as a legitimate choice. It randomised 1,643 men to active monitoring, prostatectomy or radiotherapy; at fifteen years prostate cancer mortality was low and not significantly different between arms, treatment roughly halved metastasis at the cost of side effects, and about sixty percent of monitored men were eventually treated. OnCo links it to active surveillance, MRI-first screening, Freddie C. Hamdy and the bottleneck of overdiagnosis. Whether modern MRI and biomarkers can pick out the minority who need treatment from the start is the open question.","status":"completed","asOf":"2026-09-06","links":[{"label":"ClinicalTrials.gov NCT02044172","url":"https://clinicaltrials.gov/study/NCT02044172"},{"label":"ProtecT 15-year outcomes (New England Journal of Medicine 2023)","url":"https://doi.org/10.1056/NEJMoa2214122"},{"label":"ProtecT 10-year outcomes (New England Journal of Medicine 2016)","url":"https://doi.org/10.1056/NEJMoa1606220"},{"label":"ProtecT patient-reported outcomes (New England Journal of Medicine 2016)","url":"https://doi.org/10.1056/NEJMoa1606221"},{"label":"ISRCTN registry ISRCTN20141297","url":"https://www.isrctn.com/ISRCTN20141297"}],"tags":[],"related":[],"cancers":["prostate","prostate-low-risk","prostate-intermediate-risk"],"sections":[],"technologies":["active-surveillance"],"targets":[],"drugs":[],"companies":[],"institutions":["oxford-cancer","bristol-haematology-oncology-centre"],"pathways":[],"terms":["prostate-treatment-choice-localised"],"trials":["pivot","spcg-4","pace-b"],"people":["freddie-hamdy","jenny-donovan"],"bottlenecks":[],"keyPapers":["paper-protect-nejm-2016","paper-protect-bju-int-2026-update"],"journals":[],"dependsOn":[],"notes":["At 15 years (range 11 to 21), follow-up was complete for 1,610 of 1,643 men (98 percent) and more than a third had intermediate-risk or high-risk disease at diagnosis. Death from any cause occurred in 356 men (21.7 percent), similar across groups. Long-term androgen deprivation was started in 69 monitored men (12.7 percent), 40 after surgery (7.2 percent) and 42 after radiotherapy (7.7 percent). In the active-monitoring group 133 men (24.4 percent) were alive at the end of follow-up without any prostate cancer treatment. No treatment complications were reported after the 10-year analysis (New England Journal of Medicine 2023).","The 10-year analysis reported 17 prostate cancer deaths in total, eight under monitoring, five after surgery and four after radiotherapy (p=0.48), with metastases in 33, 13 and 16 men respectively (p=0.004) and disease progression in 112, 46 and 46 (p<0.001) (New England Journal of Medicine 2016).","The patient-reported outcomes, collected before diagnosis, at 6 and 12 months and annually to 6 years with completion above 85 percent for most measures, are what make the trial usable in a consultation. Prostatectomy had the greatest negative effect on sexual function and urinary continence, and both remained worse than the other groups throughout despite some recovery. Radiotherapy's effect on sexual function was worst at 6 months, partly recovered, then stable, and it had little effect on urinary continence; bowel function was worse at 6 months and partly recovered except for increasingly frequent bloody stools. Sexual and urinary function declined gradually under active monitoring. No significant differences were seen between groups in anxiety, depression, or general or cancer-related quality of life (New England Journal of Medicine 2016)."],"nct":"NCT02044172","phase":"3","setting":"PSA-detected localised prostate cancer: active monitoring vs prostatectomy vs radiotherapy","sponsor":"UK NIHR (Oxford, Bristol)","result":"15-year prostate-cancer mortality 3.1% (monitoring), 2.2% (surgery), 2.9% (radiotherapy); no significant difference.","started":"2001-06-01","startedType":"actual","yearReported":2016,"enrolled":1643,"enrolledBasis":"randomised","enrolledNote":"82,429 men aged 50 to 69 had a PSA test, 2,664 were diagnosed with localised prostate cancer and 1,643 were randomised; NCT02044172 records the trial rather than the screening population.","outcomes":[{"endpoint":"Prostate-cancer-specific mortality at 15 years","primary":true,"unit":"%","arms":[{"name":"Active monitoring","n":545,"value":3.1,"note":"No significant difference between arms"},{"name":"Prostatectomy","n":553,"value":2.2},{"name":"Radiotherapy","n":545,"value":2.9}],"source":"https://www.nejm.org/doi/full/10.1056/NEJMoa2214122"},{"endpoint":"Death from prostate cancer at 15 years","primary":true,"unit":"%","arms":[{"name":"Active monitoring","n":545,"value":3.1},{"name":"Radical prostatectomy","n":553,"value":2.2},{"name":"Radical radiotherapy","n":545,"value":2.9}],"p":"0.53","source":"https://doi.org/10.1056/NEJMoa2214122"},{"endpoint":"Metastases at 15 years","unit":"men","arms":[{"name":"Active monitoring","n":545,"value":51},{"name":"Radical prostatectomy","n":553,"value":26},{"name":"Radical radiotherapy","n":545,"value":27}],"source":"https://doi.org/10.1056/NEJMoa2214122"},{"endpoint":"Clinical progression at 15 years","unit":"men","arms":[{"name":"Active monitoring","n":545,"value":141},{"name":"Radical prostatectomy","n":553,"value":58},{"name":"Radical radiotherapy","n":545,"value":60}],"source":"https://doi.org/10.1056/NEJMoa2214122"}],"replication":"Consistent with PIVOT and SPCG-4 in showing very low mortality from low- and intermediate-risk disease under conservative management."},"route":"/trials/protect/","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":"prostate-screening-psa-mri","kind":"technology","name":"PSA and MRI-first prostate cancer screening","route":"/technologies/prostate-screening-psa-mri/"}],"institution":[{"id":"bristol-haematology-oncology-centre","kind":"institution","name":"Bristol Haematology and Oncology Centre","route":"/institutions/bristol-haematology-oncology-centre/"},{"id":"oxford-cancer","kind":"institution","name":"Oxford Cancer (Oxford University Hospitals and University of Oxford)","route":"/institutions/oxford-cancer/"}],"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":"clinical-equipoise","kind":"term","name":"Clinical equipoise","route":"/terms/clinical-equipoise/"},{"id":"prostate-focal-therapy","kind":"term","name":"Focal and tissue-preserving treatment of prostate cancer","route":"/terms/prostate-focal-therapy/"},{"id":"prostatectomy","kind":"term","name":"Radical prostatectomy","route":"/terms/prostatectomy/"},{"id":"randomised-trial","kind":"term","name":"Randomised trial","route":"/terms/randomised-trial/"}],"trial":[{"id":"nct01310894","kind":"trial","name":"Efficacy and Safety Study of TOOKAD® Soluble for Localised Prostate Cancer Compared to Active Surveillance","route":"/trials/nct01310894/"},{"id":"erspc","kind":"trial","name":"ERSPC (European Randomized Study of Screening for Prostate Cancer)","route":"/trials/erspc/"},{"id":"pace-b","kind":"trial","name":"PACE-B","route":"/trials/pace-b/"},{"id":"pivot","kind":"trial","name":"PIVOT (Prostate Cancer Intervention Versus Observation Trial)","route":"/trials/pivot/"},{"id":"spcg-4","kind":"trial","name":"SPCG-4 (Scandinavian Prostate Cancer Group Study 4)","route":"/trials/spcg-4/"}],"person":[{"id":"freddie-hamdy","kind":"person","name":"Freddie C. Hamdy","route":"/people/freddie-hamdy/"},{"id":"jenny-donovan","kind":"person","name":"Jenny Donovan","route":"/people/jenny-donovan/"}],"paper":[{"id":"paper-protect-bju-int-2026-update","kind":"paper","name":"Long-term outcomes of cribriform-positive and cribriform-negative prostate cancer treated with radical prostatectomy in the ProtecT trial","route":"/key-papers/paper-protect-bju-int-2026-update/"},{"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/"}],"bottleneck":[{"id":"b-overdiagnosis","kind":"bottleneck","name":"Overdiagnosis and false alarms","route":"/bottlenecks/b-overdiagnosis/"},{"id":"b-surgery-radiation-innovation","kind":"bottleneck","name":"Surgery and radiotherapy cure most, get least","route":"/bottlenecks/b-surgery-radiation-innovation/"}]}}