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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.
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.
Between 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.
One 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.
The 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.
Oncological outcomes for the non-metastatic and metastatic cohorts are reported separately and are the results that will decide whether patches become an option.
Numbers are from the trial as recorded here; see the source links in the table below. This is orientation, not medical advice: ask your team how closely the trial population matches you.
1,694 randomised.
Numbers not yet public.
Source| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Time to first cardiovascular eventprimary | Transdermal oestradiol patches | 904 | - | 1.11 (0.8 to 1.53) | 0.54 | link |
| Luteinising hormone-releasing hormone agonist | 790 | - | ||||
| Hot flushes, any grade | Transdermal oestradiol patches | 807 | 35% | - | <0.0001 | link |
| Luteinising hormone-releasing hormone agonist | 730 | 86% | ||||
| Gynaecomastia, any grade | Transdermal oestradiol patches | 807 | 86% | - | <0.0001 | link |
| Luteinising hormone-releasing hormone agonist | 730 | 38% |
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