Would a randomised clinical trial for focal therapy be feasible?

Grant information

Why did we fund this project?

• Men who have localised prostate cancer, that has not spread to other parts of the body, may be offered a range of treatments. Options such as radiotherapy and surgery treat the whole prostate and can be very effective, but may have significant side effects such as incontinence and erectile dysfunction.
• Focal therapies target only the areas of the prostate that contain cancer cells, minimising damage to the rest of the prostate, and thereby reducing side effects.
• Professor Ahmed and Mr Shah wanted to see whether enough men would be willing to be randomly assigned to different treatment options, to help them plan the most effective clinical trials that compare the effect of different treatments on cancer progression and survival.

What did the team do?

• Men with localised prostate cancer were offered the opportunity to take part in a pilot trial where they were randomly assigned focal therapy or treatment of the whole prostate (surgery or radiotherapy).
• Men who did not wish to be randomised in this way were offered the opportunity to take part in a second part of the trial, where they were randomly assigned focal therapy alone, or focal therapy in combination with additional medication.

• The team measured how many men were approached, how many men agreed to each part of the trial, and how many men chose to change their treatment option following randomisation. Any side effects or complications of the different treatment options were also monitored.

What did the team achieve?

• Recruitment of men to be randomised between focal therapy and treatment of the whole prostate proved to be challenging. Many men wanted to choose which treatment they received, or had a preference for focal therapy, and so declined to be randomised between the treatment options. 
• Some men took part initially, but chose to change to focal therapy after they were randomly allocated to treatment of the whole prostate.
• However, there was a high level of acceptance to randomisation between focal therapy and focal therapy in combination with medication, and men did not wish to change treatment option following randomisation.

What does this mean for men?

• The team discovered that it would be feasible to run a large-scale trial in the future to investigate if the use of additional medication alongside focal therapy improves long term outcomes, which may help men who chose this treatment option live longer, healthier lives.
• Running pilot trials to inform the planning of large clinical trials helps ensure that valuable research funds are appropriately directed to research that is feasible and most likely to report meaningful outcomes that improve understanding of the best treatment options for men.