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What is the study about?

Square Bullet Point What is the purpose of the ProtecT study?

Square Bullet Point What treatments are there for localised prostate cancer?

Square Bullet Point How many men will be involved in the ProtecT study?

Square Bullet Point Current Phase of the study

Square Bullet Point What about data confidentiality?

Square Bullet Point A step-by-step guide to the ProtecT study

Square Bullet Point View more general information on participating in clinical trials

 

What is the purpose of the ProtecT study? Top

We need to find out about the best way of treating prostate cancer before it causes any problems. At present, nobody knows which of three treatments is best: an operation to remove the prostate, or radiotherapy to the prostate, or careful monitoring with regular checkups. This study is not a trial of screening. There are no plans to introduce screening for prostate cancer in the UK because there is not enough evidence about treatment for the disease. It has not yet been shown that screening for prostate cancer is a good idea. The aim of the ProtecT study is to find out which treatments are best.

What treatments are there for localised prostate cancer? Top

The three treatments available in the ProtecT study are:

1. Conformal radiotherapy. Carefully controlled radiation aims to destroy the cancer cells. The treatment takes 10-15 minutes, five times a week, usually for 6-8 weeks.

2. Prostatectomy. A surgeon aims to remove the cancer and prostate completely through a cut in the abdomen (belly). The operation takes about 4 hours, and requires a stay in hospital of 4-7 days.

3. Active monitoring. PSA levels are measured every 3-6 months. The aim is to identify developing cancers early enough to allow treatment with surgery or radiotherapy.

Each treatment has its own advantages and disadvantages, and these will be discussed in detail with men in the ProtecT study.

How many men are involved in the ProtecT study? Top

Between June 2001 and October 2008, approximately 109,750 men have taken part in the ProtecT study.

Current phase of study

Follow Up Phase of ProtecT study

What about data confidentiality? Top

ProtecT Study Procedures for Personal Data

All personal information collected by the ProtecT study is with the consent of the individual and is handled and stored safely and securely in accordance with the UK Data Protection Act 1998. This act specifies the ways in which personal data must be protected.

Personal data held by the study are stored in locked filing cabinets in offices that are locked outside office hours. Computerised data are stored on computers that are password protected. Only authorised ProtecT study staff can access the data. Personal data are not transferred to any organisations outside of the ProtecT consortium. No organisation in the ProtecT consortium uses personal data for commercial gain.

The only questionnaires or information (such as a study newsletter) that you will receive as a result of taking part in the ProtecT study will be clearly marked with the ProtecT label. The questionnaires will only relate to the ProtecT study research that you have agreed to take part in. It is possible that you may receive correspondence from other organisations about prostate cancer or related diseases. Your name and address has not been supplied by the ProtecT study.

A Step-by-Step to the ProtecT study

Square Bullet Point Study information sheet 1 and flow chart

Square Bullet Point Study information sheet 2

 

Centre Lead Nurses March 2010, from left: Lynne Bradshaw, Bristol, Norma Lyons, Edinburgh, Debbie Cooper, Leeds, Pauline Thompson, Birmingham, Pippa Herbert, Cambridge, Sue Bonnington, Leicester, Joanne Howson, Sheffield, Athene Lane, Trial Coordinator Bristol, Pete Holding, Sheffield, Sarah Tidball, Cardiff, Tricia O'Sullivan, Bristol and Teresa Lennon, Newcastle.

 

Why was this research needed?

Randomised Controlled Trials (RCTs) are generally accepted to be the best scientific method of advancing understanding about the effectiveness of medical treatments. Little is know about who should recruit patients to RCTs. This study compared nurses and surgeons (consultant urologists).

What is an RCT?

When we do not know the best way of treating patients, we need to make a scientific, unbiased comparison. People are put into groups and then compared. The groups are selected by a computer which has no information about the individual, e.g. their age, where they live etc. This selection by chance ('random') is the only failsafe (and scientifically reliable) way of making sure there is no bias in how people are allocated to groups. Patients in each group then have a different treatment and the groups can be compared to see if there is any difference in outcome between them.

Recruiting people to take part in RCT's can be difficult for several reasons: firstly people may find it difficult to accept that a doctor can be truly uncertain about the best treatment; people may find it hard to accept that this uncertainty justifies having their treatment choice determined by chance; people may not realise that it is only by carrying out studies where people are randomly assigned to a treatment that it is possible to advance our understanding of the effectiveness of treatments. People who chose their treatment or have their treatment chosen by doctors cannot be included in such studies and therefore their experience will not advance scientific understanding in the same way.

As a result, recruiting people to take part in RCT's can be difficult. If recruitment rates to a study are low this reduces the confidence with which findings can be generalised to other people. This reduces the value of the whole study. This publication describes how a comparison was made between how successful and how cost effective nurses were as compared to surgeons in recruiting people to the ProtecT study (a study to compare treatments for localised prostate cancer).

What was done during the pilot study?

Between 1999 and 2001 an initial study was undertaken. Men who had been identified as having prostate cancer that was contained within the prostate gland ('localised prostate cancer') were allocated by chance ('randomised') to see either a nurse or a surgeon for an information appointment. The purpose of the information appointment was to talk through information about treatment and discuss with the man whether he would be happy to consent to being randomly allocated to surgery, radiotherapy or active monitoring within the ProtecT study. The number of men agreeing to randomisation following an appointment with a nurse was compared to the number of men agreeing to randomisation following an appointment with a surgeon. Costs of the appointment as carried out by a nurse or by a surgeon were calculated by determining the length of the information appointment and the pay grades of nurses and surgeons respectively.

What was found?

167 men were identified and of these 150 (90%) agreed to take part in this recruitment study. There was a small but not significant difference in the numbers recruited by nurses and surgeons (67% by nurses, 71% by surgeons). Information appointments carried out by nurses were longer than those carried out by surgeons. However, once pay grades were taken into account, the cost of a surgeon carrying out the information appointment was higher.

What conclusions can be drawn?

Nurses were similar to surgeons in their success in recruiting patients and were less expensive recruiters.

These results suggest that it is nurses who should take on the role of recruiting people to RCT's in future. This will be the case for the main ProtecT study.