We need 100 men to join the feasibility study. The aim of the feasibility study is to find out if it is possible to carry out the same research in a larger number of men. Patients in the first part of the study would be treated as if they were in the main, larger phase of the trial and have the same assessments and follow-up visits. If the feasibility study is successful, the larger study will recruit between 600 and 800 men. The patients recruited into the first phase of the trial would automatically be rolled into the second phase of the study.
Patients in the first part of the study would be treated as if they were in the main part of the study.
CONSENT & RANDOMISATION
If, after you have spoken to your doctor about all your treatment options and the PART study in more depth and you decide to join the study, you will be given an information leaflet to keep and asked to sign the PART study consent form. You will then be entered into the PART study and the research nurse or your doctor will tell you which treatment you have been assigned to straight away.
You will have an equal chance of having either HIFU or surgery and neither you nor your doctor will be able to decide which group you are in. This process ensures that the treatments are compared fairly.
The best way to compare two treatments is to have similar groups of patients allocated to either HIFU or surgery (radical prostatectomy). The only way to make sure that the groups of patients are as similar as possible is to have the allocation decided by chance: a process called randomisation. This means that you will have an equal chance of having either HIFU or surgery and neither you nor your doctor will be able to decide which group you are in. This process ensures that the treatments are compared fairly. It is important for the study that you only agree to take part if you believe you would be prepared to accept either treatment. Whichever treatment you are allocated to, you will be treated with the best possible care and the surgeon treating you will be experienced in the technique. Both stages (the feasibility study and larger study) are randomised.
Whichever treatment you are allocated to, you will be treated with the best possible care and the surgeon treating you will be experienced in the technique.
Men in one group have an operation to remove their prostate gland (prostatectomy). Men in the other group have focal therapy using high intensity focused ultrasound (HIFU) to treat the areas of cancer in the prostate.
All information which is collected about you during the course of the research will be kept strictly confidential.
In the first stage of the PART study (the feasibility study) we will ask you if we can tape-record your information visit with your doctor and research nurse. This will help us to make sure that you are provided with enough information about the treatments and the study. We will ask you for written permission before this happens and this is called a Qualitative Recruitment Investigation or QRI.
Read more about procedures, hospital visits and side effects by clicking here.