A home test kit for prostate cancer that could help with early diagnosis of aggressive forms of the disease while reducing the need for trips to hospital is being trialled.
Researchers will post kits to 2,000 men in the UK, Europe and Canada, with participants asked to give two urine samples to return by mail for lab analysis.
Teams from the University of East Anglia (UEA) and the Norfolk and Norwich University Hospital (NNUH) trialled the kit with a small group of participants before the latest phase of the study.
The Prostate Screening Box aims to diagnose aggressive prostate cancer, which will require treatment, by looking at gene expressions in urine.
In the pilot study it did so up to five years earlier than standard clinical methods, according to the researchers.
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 tumours will become aggressive, making it hard to decide on treatment for many men.”
He said the most commonly used tests for prostate cancer include blood tests, a physical examination known as a digital rectal examination, an MRI scan or a biopsy.
The urine tests could make monitoring of cancer in men “so much less stressful for them and reduce the number of expensive trips to the hospital”, said Dr Clark.
He said that secretions from the prostate, just below the bladder, naturally flow into the urethra and end up in urine.
These carry cells and molecules from all over the prostate, and analysis of the urine is a way of sampling the whole prostate in one go.
The first of two urine samples is taken first thing in the morning, to include overnight secretions, and the second sample an hour later.
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 revolutionise how those on ‘active surveillance’ are monitored for disease progression, with men only having to visit the clinic after a positive urine result.”
Participants in the study are in three categories: men who have had a prostate-specific antigen (PSA) test, usually at their GP surgery, and the result suggests they possibly have prostate cancer; men with low-risk prostate cancer that may progress to a more aggressive form; and men with a genetic predisposition to having prostate cancer but who do not have cancer at present.
The men are usually between 55 and 80.
Currently, men with low-risk cancer and on active surveillance are recalled to the clinic every six to 12 months for a range of tests including a digital rectal examination, PSA test, biopsies and MRI.
Dr Clark hopes the urine tests could enable men with a negative test to be retested less frequently, every two to three years, “relieving stress to the patient and reducing hospital workload”.
Robert Mills, consultant clinical director in urology at NNUH, said: “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.”
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.