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A promising new urine test for prostate cancer is being developed.

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UK researchers are developing a new test for prostate cancer. The test uses a urine sample to look for 36 genes that indicate the presence of prostate cancer. It may also be useful for men who have already been diagnosed. It’s hoped that this new test can more accurately predict the risk of prostate cancer than current methods.

Prostate cancer diagnosis and prognosis

The process by which prostate cancer is diagnosed urgently needs improving. For early detection, that comes before symptoms of the cancer, we rely on the PSA blood test. But the PSA test is not a test for cancer. Rather, men with a high PSA have a high risk of having prostate cancer.

Following a high PSA reading, doctors may recommend a digital rectal exam (finger test), an MRI scan or other types of scan, and finally a biopsy for the actual diagnosis. The biopsy is an invasive process. It involves inserting needles into many regions of the prostate to remove tissue. It can be uncomfortable, painful, involve blood loss and sometimes bring side effects such as infections or tissue damage.

Many men have biopsies but don’t have prostate cancer. Therefore, these biopsies are potentially avoidable. An accurate biomarker using a less invasive test would improve the diagnosis procedure, therefore avoiding some of these unnecessary biopsies.

Another process that needs improvement is determining prognosis. Prognosis is the predicted course and outcome from the cancer. For localised prostate cancer, we want to know the risk that the cancer will spread, that is, the risk that it will become advanced prostate cancer. Knowing this risk helps to determine the best management for the cancer. This could be active surveillance, surgery, radiotherapy or hormone therapy (androgen deprivation therapy, ADT). At the moment, only diagnosis from a biopsy can provide a Gleason score, which indicates how quickly the tumours are growing. 

Determining risk for localised prostate cancer

One method used by doctors to determine prognosis is the D’Amico stratification system. This uses PSA readings and the Gleason Score to label localised prostate cancer as low, intermediate or high risk. The risk refers to whether PSA will rise again after initial treatment. Rising PSA indicates recurrence of the prostate cancer and a risk of metastatic disease.

Another risk classification method is called the CAPRA score. This method takes into account other information such as age, percent of biopsy samples with tumour tissue, pre-treatment PSA and Gleason Score. The CAPRA score is on a scale of 0 to 10. Like D-Amico stratification, it predicts the likelihood of PSA rising after treatment.

 A new urine test for detecting prostate cancer is being developed.

Scientists from the University of East Anglia in the UK are developing a urine test called PUR4. They hope that this will be a useful test before biopsy to detect prostate cancer.

The new test detects the use of 36 different genes by finding traces of these genes in urine samples. When genes are being used by the body, trace copies of them can be detected. These are called RNA copies of the gene. The more RNA present from a particular gene, the more that gene is being used. The UK researchers detected RNA copies for many different genes in the urine of men in the study. They established a list of genes with high levels of RNA present in the urine of men with prostate cancer. This helped them determine an optimal group of 36 genes that, when detected in the urine, indicate a high risk of prostate cancer.

The PUR4 test predicted whether men have no prostate cancer, or low, intermediate or high-risk prostate cancer. The new test was not perfect, but it was more accurate than the PSA blood test when used for 177 men in the study.

A successful urine biomarker could have some advantage over a biopsy because it takes a more holistic approach; it does not reply on hitting the right spot in the prostate with the biopsy needles.

The PUR4 test may also be useful for determining prognosis. For men who have already been diagnosed, the test could predict the risk of their disease turning aggressive. This was examined in a cohort of 87 men in the UK study. The PUR4 test was more accurate than current methods in predicting prognosis for these 87 men.

A more accurate test for prognosis could be helpful for men on active surveillance. These men have slow-growing, low-risk prostate tumours. By having regular tests, they delay prostate cancer treatment until it becomes necessary, if it does. Hopefully the PUR4 test can used to better predict the need for treatment for men on active surveillance. This could reduce the number of invasive biopsies needed by these men.

Will the PUR4 test make it onto the market?

Development of the PUR4 test is still ongoing. This test needs independent validation in an entirely new cohort of men. We also need a “prospective trial” to demonstrate that it works. In such as trial, men having the test will be followed-up into the future to determine whether the test made a difference to their prostate cancer journey.

Many biomarkers have been developed in the past that have not made it onto the market for widespread use. Often these biomarkers look very promising at early stages, but don’t perform well in independent validation or trials with a wide variety of men.

An issue with the PUR4 test is that the urine samples in this study were given after a digital rectal exam (DRE or finger test). Australia is steering away from DREs done by general practitioners. PCFA recommends that DREs be performed by properly-trained urologists after a high PSA reading. If this PUR4 test is to replace the PSA test in Australia, then we need to know how it performs on men who haven’t had a DRE.

Regardless of the issues with diagnosis and DREs, the PUR4 test could still be a very useful prognosis test in Australia, if it performs well in external validation and prospective trials.

This study was funded by The Movember Foundation as part the GAP1 initiative. The GAP1 (Global Action Plan 1) aims to develop better tests that more accurately distinguish between low-risk and aggressive forms of prostate cancer by examining biomarkers in blood, urine and tissue.

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