{"entity":{"id":"patch-transdermal-oestradiol","kind":"trial","name":"PATCH (Prostate Adenocarcinoma Transcutaneous Hormone)","aka":["PATCH","Prostate Adenocarcinoma Transcutaneous Hormone","transdermal oestradiol trial"],"tldr":"Oestrogen patches suppress testosterone as well as the standard injections, protect the bones instead of thinning them, and, contrary to what killed the idea in the 1970s, do not cause more heart attacks and strokes.","summary":"Oral oestrogens were abandoned as prostate cancer treatment because they caused fatal cardiovascular events. Transdermal oestradiol bypasses first-pass hepatic metabolism, and PATCH was designed to find out whether that removes the harm while keeping the benefit.\n\nBetween August 2007 and July 2019 PATCH randomly allocated 1,694 men at 52 UK sites, 790 to a luteinising hormone-releasing hormone agonist and 904 to oestradiol patches, with allocation 1:2 from 2007 and 1:1 from February 2011. Median follow-up was 3.9 years. Castration rates at 1 month and 3 months were 65 and 93 percent with the agonist and 83 and 93 percent with patches: the patches worked faster and equally well.\n\nOne hundred and fifty-seven cardiovascular events meeting predefined criteria occurred in 145 men, with ten further sudden deaths without a post-mortem report, 167 events in 153 men in total. Twenty-six of 1,694 men (2 percent) had a fatal cardiovascular event, 15 of 790 on the agonist and 11 of 904 on patches. Time to first cardiovascular event did not differ, hazard ratio 1.11 (95 percent confidence interval 0.80 to 1.53, p=0.54) including sudden deaths without a post-mortem, or 1.20 (0.86 to 1.68, p=0.29) in the confirmed group only.\n\nThe side-effect profiles are mirror images and matter to how a man chooses. Gynaecomastia of any grade affected 279 of 730 men (38 percent) on the agonist and 690 of 807 (86 percent) on patches (p<0.0001); hot flushes affected 628 (86 percent) on the agonist and 280 (35 percent) on patches (p<0.0001). The programme, reported in Clinical Oncology in 2024, also found bone mineral density at the lumbar spine fell by a mean 3.0 percent with the agonist and rose by 7.9 percent with patches, an estimated difference of 9.3 percent (5.3 to 13.4), with better metabolic parameters and quality of life.\n\nOncological outcomes for the non-metastatic and metastatic cohorts are reported separately and are the results that will decide whether patches become an option.","status":"active","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT00303784","url":"https://clinicaltrials.gov/study/NCT00303784"},{"label":"ISRCTN registry ISRCTN70406718","url":"https://www.isrctn.com/ISRCTN70406718"},{"label":"PATCH long-term cardiovascular outcomes (Lancet 2021)","url":"https://doi.org/10.1016/S0140-6736(21)00100-8"},{"label":"PATCH and STAMPEDE repurposing programme (Clinical Oncology 2024)","url":"https://doi.org/10.1016/j.clon.2023.10.054"}],"tags":[],"related":[],"cancers":["prostate","prostate-mhspc","prostate-high-risk"],"sections":[],"technologies":["androgen-deprivation"],"targets":[],"drugs":[],"companies":["mrc-ctu"],"institutions":["uclh"],"pathways":[],"terms":["adt","hormone-therapy","qol-pro"],"trials":["stampede","swog-9346"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT00303784","phase":"2/3","setting":"Locally advanced or metastatic prostate cancer needing androgen suppression: oestradiol patches, four 100 microgram patches per 24 hours changed twice weekly and reduced to three if castrate at 4 weeks, against a luteinising hormone-releasing hormone agonist by local practice, with cardiovascular morbidity and mortality as the primary outcome of this analysis","sponsor":"MRC Clinical Trials Unit at UCL, funded by Cancer Research UK and the Medical Research Council","result":"Transdermal oestradiol suppressed testosterone as well as a luteinising hormone-releasing hormone agonist with no difference in time to first cardiovascular event (hazard ratio 1.11, 95 percent confidence interval 0.80 to 1.53); hot flushes 35 against 86 percent, gynaecomastia 86 against 38 percent, lumbar spine bone density plus 7.9 against minus 3.0 percent.","yearReported":2021,"enrolled":1694,"enrolledBasis":"randomised","enrolledNote":"1,694 men had been randomised at the cardiovascular analysis of July 2019; recruitment has since completed with 1,362 men in the non-metastatic cohort and 1,128 in the metastatic cohort, reported separately. The trial is registered as ISRCTN70406718 and recruits through the STAMPEDE platform as well.","outcomes":[{"endpoint":"Time to first cardiovascular event","primary":true,"arms":[{"name":"Transdermal oestradiol patches","n":904},{"name":"Luteinising hormone-releasing hormone agonist","n":790}],"hr":1.11,"ci":[0.8,1.53],"p":"0.54","source":"https://doi.org/10.1016/S0140-6736(21)00100-8"},{"endpoint":"Hot flushes, any grade","unit":"%","arms":[{"name":"Transdermal oestradiol patches","n":807,"value":35},{"name":"Luteinising hormone-releasing hormone agonist","n":730,"value":86}],"p":"<0.0001","source":"https://doi.org/10.1016/S0140-6736(21)00100-8"},{"endpoint":"Gynaecomastia, any grade","unit":"%","arms":[{"name":"Transdermal oestradiol patches","n":807,"value":86},{"name":"Luteinising hormone-releasing hormone agonist","n":730,"value":38}],"p":"<0.0001","source":"https://doi.org/10.1016/S0140-6736(21)00100-8"}],"replication":"The oestradiol comparison was also run inside the STAMPEDE platform, which is how the sample size was reached; no independent trial has repeated it."},"route":"/trials/patch-transdermal-oestradiol/","neighbours":{"cancer":[{"id":"prostate-high-risk","kind":"cancer","name":"Localised prostate cancer, high and very high risk","route":"/cancers/prostate-high-risk/"},{"id":"prostate-mhspc","kind":"cancer","name":"Metastatic hormone-sensitive prostate cancer","route":"/cancers/prostate-mhspc/"},{"id":"prostate","kind":"cancer","name":"Prostate cancer","route":"/cancers/prostate/"}],"technology":[{"id":"androgen-deprivation","kind":"technology","name":"Androgen deprivation & AR pathway inhibitors","route":"/technologies/androgen-deprivation/"}],"company":[{"id":"mrc-ctu","kind":"company","name":"MRC Clinical Trials Unit at UCL","route":"/companies/mrc-ctu/"}],"institution":[{"id":"uclh","kind":"institution","name":"University College London Hospitals / UCL Cancer Institute","route":"/institutions/uclh/"}],"term":[{"id":"adt","kind":"term","name":"Androgen deprivation therapy (ADT)","route":"/terms/adt/"},{"id":"hormone-therapy","kind":"term","name":"Hormone therapy","route":"/terms/hormone-therapy/"},{"id":"qol-pro","kind":"term","name":"Quality of life and patient-reported outcomes (QoL, PRO)","route":"/terms/qol-pro/"},{"id":"prostate-stampede-arms","kind":"term","name":"STAMPEDE's arms, and what each one answered","route":"/terms/prostate-stampede-arms/"},{"id":"prostate-adt-burden","kind":"term","name":"What androgen deprivation costs: the side of hormone therapy the survival curves do not show","route":"/terms/prostate-adt-burden/"}],"trial":[{"id":"hero","kind":"trial","name":"HERO","route":"/trials/hero/"},{"id":"stampede","kind":"trial","name":"STAMPEDE","route":"/trials/stampede/"},{"id":"swog-9346","kind":"trial","name":"SWOG 9346 (intermittent androgen deprivation)","route":"/trials/swog-9346/"}]}}