Taking Part in the TRANSLATE Trial

What will happen if I take part in the study?

Should you decide to take part, you are still free to withdraw at any time and without giving a reason. This will not affect the standard of care you receive as either an inpatient or an outpatient from the NHS.  

If you are happy to take part in this study, a researcher will ask you some simple questions and check your medical history to confirm that you are eligible.

INITIAL ASSESSMENT

If you are eligible, you will be asked to sign and date a consent form for the study. We will then ask you some questions about your medical history and to check you would be suitable to have your biopsy using any technique. These questions should take you no more than 10 minutes to answer. 

There are no additional tests that you will have as a result of agreeing to take part in this study. As part of standard NHS care, you will have a blood tests and scans – we will ask for your permission to review and record these results for the study team.

TREATMENT ALLOCATION

You will then be randomly allocated to one of the study groups by a computer, i.e. allocation is by chance. You will have an equal chance of being allocated to either group, like the toss of a coin. The computer will allocate you to have one of the following:

• Transperineal prostate biopsy performed under a local anaesthetic.
• Transrectal ultrasound guided biopsy performed under local anaesthetic.

There is a 50% chance that you will be in either group, and currently doctors do not know which biopsy technique is best – this study will definitely answer this question – so in a few years’ time – men will always be offered one of these techniques as the main way at detecting prostate cancer. 

Being part of the TRANSLATE study will not change the way your local hospital cares for you and the standard treatments they would give you.   

The random allocation is important because this way, we can test the different treatments fairly and nobody can influence into which group you are placed. Your healthcare and research teams will not be able to affect which group you are put into and you will not be able to choose. 

Are there any optional parts of the study?
No.

What happens after I leave the hospital?

If you agree to take part in the study, we will ask you to complete some questionnaires before you have your biopsy.  We will then ask to complete the questionnaires again 7 days, 35 days and 4 months after your biopsy to see how you are after the biopsy. The questionnaires would ideally be sent to you by email – but if you request we could post them to you.

Members of the TRANSLATE research team may then take the results of any clinical tests, X-rays and observations taken from your medical notes.

There will be no additional tests requested by the research team.

What are the risks and benefits of taking part in the study?

The information from this study we hope will answer the question of which biopsy is ultimately best for detecting prostate cancer balanced with the complications and side effects of each procedure. We cannot promise the study will help you directly, but the information we get has the potential to be of benefit to those who come to hospital in the future with potential signs of prostate cancer.

People sometimes feel uncomfortable answering certain questions about their health, or may be unable to answer. If you feel uncomfortable at any point, then you do not have to answer the questions. The table below shows some of the main side effects of prostate biopsies.

What happens at the end of the study?

We will share the results with healthcare researchers and professionals to improve future suspected prostate cancer patient care. Also, we will present them in research reports, at scientific conferences, and publish them in scientific journals.  The study results will also be publically available at www.translate.octru.ox.ac.uk at the end of the study. 

We will not include any data that could identify you in the results. If any of the funders of this research ask us to make the study data available for other researchers or to themselves, we will first make your information anonymous (ie. we will take your name and other identifying details out) so that you cannot be identified.