Trials for Prostate Cancer
Clinical trials are organised into four phases, of which Phases 2 and 3 are perhaps the most relevant. Phase 2 trials normally recruit a relatively small number of patients (typically 50–100) in order to establish whether the new drug/method is showing some useful activity. Phase 3 trials recruit a much larger number of patients. Patients are divided into those receiving the new drug or treatment method and those having standard treatment (the ‘control arm’). In ‘blind’ or ‘double-blind' randomised trials even the doctor may not know which arm the patient is on.
Trials are run across many of the teaching hospitals of the UK. An individual trial may also be accessed across different UK trials units. So it is important to find the unit that is most conveniently located to you, and to check whether or not any travel expenses are paid.
Advantages and disadvantages
How to get on a trial
From the websites above select a suitable trial and request your GP to forward your name to the appropriate unit for evaluation. The trials website is not always up to date, so a call to the unit to ensure the trial is still recruiting is worth the time.
Some trials for specific therapies
High Intensity Focused Ultrasound, as a primary curative treatment, has to date mainly been offered in the private medical sector. The National Health and Clinical Excellence Agency (NICE) have yet to approve its use in the NHS. The trial, based in London at the University College of London Hospital under the leadership of Professor Mark Emberton, has a simple aim: to see how efficient this therapy is for treating localised prostate cancer.
The PACE trial is comparing a new type of radiotherapy, stereotactic body radiotherapy (SBRT – see p. 23) against standard treatment for men with localised prostate cancer. SBRT has the advantage that it is given in just 5 or 6 treatments rather than the conventional 20 treatments (see Radiotherapy). The trial is open in many UK centres.
STAMPEDE, or Systematic Therapy in Advancing or Metastatic Prostate cancer: Evaluation of Drug Efficacy. This trial is multi-centre and is open in over 100 hosptails throughout the UK. It has already recruited over 8,000 patients. Its aim is to improve survival by adding other drug components to the standard hormone therapy. As one component is completed, another treatment is added. The outcome will be the most efficient combination.
Some new drugs on trial for advanced prostate cancer
There are a number of trials testing new drugs for men who have advanced prostate cancer and have already received standard drug treatments. Most of these are phase 2 trials. The most promising agents are taken on into phase 3 trials. Olaparib, a drug that is already used to treat ovarian cancer, is about to enter a phase 3 trial in multiple UK hospitals.