Hormone patches for prostate cancer move closer after major trial

A landmark UCL study has shown that simple hormone patches, similar to those already used in women’s hormone replacement therapy (HRT), are as effective as standard injections, with fewer side effects, for men with locally advanced prostate cancer. 

In the UK, more than 55,000 men are diagnosed with prostate cancer each year, making it the most common cancer among men. The findings offer a potential new route to improve patient quality of life, while reducing the need for regular hospital visits.

The results come from a large UCL-led clinical trial involving 1,360 men across the UK, and published in The New England Journal of Medicine. The study compared the hormone patches with current standard of care - injections of LHRH agonists (luteinising hormone-releasing hormone agonists), which requires multiple hospital or GP visits, whereas oestradiol patches can be put on by patients at home.

Encouraging findings

After at least three years of follow-up, both treatments performed almost identically at controlling the cancer. 87% of men using patches were alive with no cancer spread, while 86% of men using injections had the same outcome.

However, the differences in side effects were significant. Hot flushing symptoms were reported 44% of the time with patches vs 89% with injections. Bone fractures after five years were down to 2.8% with patches vs 5.8% with injections. However, breast tissue swelling (gynaecomastia) was more frequent with patches, affecting 85% of participants compared to 42% of those on injections.

Why hormone therapy matters

Prostate cancer often relies on testosterone to grow. For decades, the standard treatment has been injections called luteinizing hormone-releasing hormone (LHRH) agonists, which switch off the body’s testosterone production. While effective, these injections lower oestrogen levels too, leading to difficult side effects such as severe hot flushes, bone thinning and changes to cholesterol or blood pressure.

The UCL trial, carried out on men with locally advanced, non-metastatic prostate cancer (i.e. cancer that had not spread to other parts of the body) tested an alternative: skin patches that deliver oestradiol (a type of oestrogen) directly into the bloodstream. This approach reduces testosterone production but avoids the very low oestrogen levels that cause many of the unwanted effects.

UCLB is working closely with Lead Author Professor Ruth Langley and the MRC Clinical Trials Unit at UCL to help progress the next steps. This includes engaging with manufacturers, navigating the licensing landscape and exploring routes to ensure the patches can become widely and confidently prescribed.

Dr Richard Fagan, Director of Biopharm, UCLB, said: "This study is a powerful example of how long‑term academic research can lead to real improvements in patients’ lives. We’re supporting Professor Langley and her team to move these findings beyond the clinic by working with potential commercial partners, navigating the licensing landscape and helping lay the groundwork for regulatory approval. Our role is to help ensure promising evidence like this can translate into treatments that are accessible, and ultimately available to the men who could benefit most."

Participants in the study were recruited from the UCL-led PATCH and STAMPEDE trials between 2007 and 2022 from 75 centres in the UK. The study was sponsored initially by Imperial College London and then UCL and funded by Cancer Research UK and the UKRI Medical Research Council (MRC) Clinical Trials Unit.

Better patient choice

The patches can be applied at home, removing the need for repeated GP or hospital appointments. Researchers note that the patches used in the study are identical to those used for women’s HRT. They are not yet licensed specifically for prostate cancer, meaning clinicians must prescribe them “off‑label”. For wider adoption, a manufacturer would need regulatory approval, a process UCLB is actively supporting.

Professor Langley notes that giving men a choice matters. She said: “We believe our findings should lead to men with locally advanced prostate cancer being able to choose which hormone therapy suits them best. For some men, for instance, hot flushes can be very debilitating, and so the patches could greatly increase their quality of life.”