The TRANSFORM study is looking at screening for prostate cancer. Screening means testing a large group of the population for a disease at any early stage before it causes symptoms. At the moment in the UK, we do not have screening for prostate cancer in the general population because we are not sure if it is the right thing to do using the tests we have. In TRANSFORM, we are testing different Prostate Health Checks to screen for prostate cancer because research has shown that they might be good at screening.  However, we cannot be sure until we do the TRANSFORM study to find out if one of these Prostate Health Checks might be a good thing for screening

The prostate is an organ that forms part of the male reproductive system. It is located immediately below the bladder, just in front of the back passage, and surrounds the beginning of the urethra, the tube that takes urine from the bladder and through the penis. Its main function is to produce fluid that makes up part of the semen.

Prostate cancer often grows very slowly or, in some cases, once established does not grow further at all. This means the chance of the cancer cells spreading and affecting a man’s life is low. In fact, we know that 1 in 3 men above the age of 50 years will have these tiny prostate cancers which will never grow or spread. We do not want to find these types of cancers as there is no benefit to the man in treating it. In fact, there can be harm in treating these cancers for the men who have them, as treatments often cause complications and side-effects. However, some prostate cancers do grow and spread and can shorten a man’s life. When these more aggressive cancers are found early in men, we can improve their survival by treating them.

Prostate cancer typically does not cause any urinary symptoms. Most urinary symptoms are caused by the bladder aging and/or natural non-cancerous (benign) prostate growth. Prostate cancer is currently diagnosed using a blood test called prostate specific antigen (PSA). If doctors are concerned about the level of PSA, then men are referred to hospital to have further tests. PSA is not specific to cancer so it cannot tell the difference between benign growth, cancers that need treatment and those that can be monitored. This means many men that do not have cancer or only have cancers that do not need treatment are currently investigated with more invasive tests in hospital. These tests can have side-effects and complications. As a result, many experts do not believe the benefits of screening the general population justify the harms that are caused.

You have received a letter from your GP inviting you to take part in TRANSFORM. Not all men are invited. There are a number of things we look at to see if you are eligible for this study. These are:

• age between 50 and 74 years

• age 45 to 74 years if you have stated in your GP records that you are of Black ethnicity

• not had a PSA test or other tests for prostate cancer or a prostate biopsy in the last 5 years

• you would not be too ill from other conditions or diseases to have treatment for prostate cancer even if we did find it

We will go through these in greater detail in the first trial visit if you wish to participate.

No. It is up to you. You will have plenty of time to decide and you are free to withdraw at any time without giving a reason and without affecting any future care you receive.  If you withdraw after giving consent, we will ask your permission to keep health information and any samples or imaging or scans for research. We will ask you whether we can continue to collect information about your health status through your GP practice or NHS or national records. This would be done without ever contacting you directly. You do not have to agree to this.

If you agree to take part, we will ask you to sign a consent form electronically. You can also sign a paper version if you prefer. Once you have done this, your details will be entered into a computer. You will then be placed into one of 5 different groups at random. There is an equal chance of being placed into any of these groups. One of the groups involves no further testing. You will not hear from us about any further testing if you are in this group, but we will continue to collect information about your health through your GP practice and other NHS and national records. We will also contact you to ask you questions about your health. We might also contact you after your test for your thoughts and opinion on the study.

If you are randomly selected for one of the Prostate Health Checks, you will get a PSA test, a prostate scan, or a genetic test. The prostate scans and genetic tests are only available in the study. We will give you full details of what Prostate Health Check you will have, what it entails, and what might happen after each Prostate Health Check.

When there are different tests for a condition and we do not know which is best, we use a randomised controlled trial (RCT) to compare them. In an RCT, patients are randomly placed in a group where they have an equal chance of offered being one of the tests which ensures the results are accurate and unbiased. The group that an individual patient is placed into is selected by a computer which has no information about the individual, and this process is called randomisation. Whichever group you are in, you will be treated with the best possible care and will be monitored closely.