Focal therapy to be put to the test in new trial

Current treatments like surgery and radiotherapy for early-stage prostate cancer often cause a wide range of side effects, such as urinary incontinence, erectile dysfunction or bowel problems. That’s why there is a lot of interest in a new type of treatment known as focal therapy, which could help to reduce side effects for some men.

Focal therapy means treating just the area with cancer while leaving the rest of the prostate undamaged. However, these treatments are only available in specialist centres or as part of clinical trials. Before they can be a standard treatment across the UK, we need to know whether they really work as well as traditional treatments like surgery and radiotherapy.

That’s why we’ve given a £500,000 Research Innovation Award to Mr Taimur Shah and Professor Hash Ahmed at Imperial College London to run a small clinical trial comparing focal therapy to surgery or radiotherapy.

To make sure that the results of a study like this are reliable, hundreds of men need to take part. So before time and money are invested in a large clinical trial, the researchers need to be sure that men will want to join the trial. To test this, they will use their Research Innovation Award to run a pilot study called CHRONOS with 60 men.

A tale of two trials

Professor Ahmed suspects that some men who really want to have focal therapy might not want to take part in a trial where there’s a chance they won’t get it. So he’s organised CHRONOS in two parts. The researchers will initially try to recruit men to the first part of the study, CHRONOS A, which compares focal therapy with either radical prostatectomy or radiotherapy.

For any men who particularly want focal therapy, the second part of the trial, CHRONOS B, will compare the effect of additional medication. This will test whether giving men a short dose of extra medication before their focal therapy treatment will improve cancer control. It will also check if any improvement comes at the expense of worsening side effects.

This means that at the end of the trial, the researchers should be able to compare focal therapy, whole gland therapy, and focal therapy plus medication to see which has the best chance of controlling the cancer while minimising side effects.

"CHRONOS is the next step to making focal therapy a reality. If we can confirm focal therapy is an effective treatment for cancer that also minimises side-effects, the potential impact to men will be immense," says Professor Ahmed, pictured below.

In Professor Ahmed’s experience, men who actively want to have focal therapy come to specialist hospitals, as it isn’t available everywhere. That means it can be difficult to recruit men to randomised trials like CHRONOS A in these centres. So Professor Ahmed is deliberately including hospitals that don’t yet perform focal therapy in his trial. He hopes that men in these hospitals won’t be expecting to be offered focal therapy, so they may be more willing to join a trial like CHRONOS A.

If these small studies are a success, Professor Ahmed and his team will try to get funding for a larger trial. This would aim to confirm that focal therapy is an effective treatment for prostate cancer, and causes fewer side effects than standard treatments. Their second trial may show that focal therapy can be made more effective with a short course of medication beforehand, reducing the need for further cancer treatment after focal therapy.

CHRONOS is due to open for recruitment later in 2019. To find other trials in your area, see our clinical trials map.

This is just one of eight exciting new research projects funded as part of this year’s Research Innovation Awards, none of which would be possible without your support. Donate today to continue to support the vital research that is saving men’s lives.