Thousands of men to trial new home test kit for prostate cancer

Thousands of men worldwide are to receive a home test kit for prostate cancer – thanks to pioneering research from the University of East Anglia and the Norfolk and Norwich University Hospital (NNUH).

Image Credit: University of East Anglia

The research team are trialing a new home-testing ‘Prostate Screening Box’ to collect men’s urine samples at-home. The urine samples will be used to analyze the health of the prostate in 2,000 men in the UK, Europe and Canada.

This simple urine test is intended to diagnose aggressive prostate cancer and in a pilot study predicted which patients required treatment up to five years earlier than standard clinical methods.

The Prostate Screening Box has been developed in collaboration with REAL Digital International Limited to create a kit that fits through a standard letterbox.

It means that men can provide a urine sample in the comfort of their own home, instead of going into a clinic or having to undergo an uncomfortable rectal examination. The research team hope that it could revolutionize diagnosis of the disease.

Lead researcher Dr Jeremy Clark, from UEA’s Norwich Medical School, said: “Prostate cancer is the most common cancer in men in the UK. However it usually develops slowly and the majority of cancers will not require treatment in a man’s lifetime. It is not a simple matter to predict which tumors will become aggressive, making it hard to decide on treatment for many men”.

“The most commonly used tests for prostate cancer include blood tests, a physical examination known as a digital rectal examination (DRE), an MRI scan or a biopsy”.

“We have developed the PUR (Prostate Urine Risk) test, which looks at gene expression in urine samples and provides vital information about whether a cancer is aggressive or ‘low risk’.

“The Prostate Screening Box part sounds like quite a small innovation, but it means that in future the monitoring of cancer in men could be so much less stressful for them and reduce the number of expensive trips to the hospital.  

“The prostate lies just below the bladder. It constantly produces secretions which naturally flow into the urethra - the tube through which urine passes from the bladder. The prostatic secretions carry cells and molecules from all over the prostate which are flushed out of the body on urination. We collect these and examine them. It’s a way of sampling the whole prostate in one go.

“As the prostate is constantly secreting, the levels of biomarkers in the urethra will build up with time. Collecting from the first wee of the day means that overnight secretions can be collected which makes the analysis more sensitive.”

The team have previously trialed the kit with a small group of participants, but in the next phase of the research study are rolling it out to thousands.

Men taking part in the trial will receive a home urine-sampling kit and will be asked to provide two urine samples – one to be taken first thing in the morning and the second an hour later. The samples will then be sent back to the lab for analysis.

Dr Clark said: “Feedback from early participants showed that the at-home collection was much preferred over sample collection in a hospital.

“We hope that using our Prostate Screening Box could in future revolutionize how those on ‘active surveillance’ are monitored for disease progression, with men only having to visit the clinic after a positive urine result.

“This is in contrast to the current situation where men are recalled to the clinic every six to 12 months for a range of tests including DRE, PSA tests, painful and expensive biopsies and MRI. We are working to develop the test to help patients in three years’ time.

“A negative test could enable men to only be retested every two to three years, relieving stress to the patient and reducing hospital workload,” he added.

This simple, non-invasive urine test has the potential to significantly change how we diagnose and manage early prostate cancer for the benefit of patients and health care systems. It may enable us to avoid unnecessary diagnosis of low risk disease as well as managing patients more appropriately with surveillance for those with low risk of progression and early curative treatment for those at high risk of progression.”

Robert Mills, Consultant Clinical Director in Urology, NNUH

Paul Villanti, executive director of programs at Movember, said: “The PUR test has great potential to transform the way prostate cancer is managed. Not only can it accurately predict when a man’s disease will become aggressive and require treatment, but it has the added advantage of allowing men to complete it at home.

“We are proud to have supported the development of the PUR test from its early stages as part of our Global Action Plan on Biomarkers, through to this trial involving thousands of men across the world.

“Through our Global Action Plan on active surveillance, we have been able to identify hundreds of men from the UK, Germany, Italy and Canada who are suitable to take part in this trial.

“We hope it will speed up the trial’s progress and get this test included as part of clinical care for men as quickly as possible.”

The research has been funded by a Movember and Prostate Cancer UK Innovation award, the Masonic Charitable Foundation, the Bob Champion Cancer Trust, the King family, the Andy Ripley Memorial Fund, the Hargrave Foundation, Norfolk Freemasons and the Tesco Centenary Grant.