Non-invasive screening tests for preventive healthcare

Improving prostate cancer screening quality and equality

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Prostate cancer is the most common cancer in men in the world. The most significant risk factor for prostate cancer is age – it mainly affects men ages 50 and over. However, this does not mean that you cannot develop prostate cancer if you are under the age of 50. Research actually suggests that the incidence of prostate cancer in men under the age of 40 has increased during the last few decades, which is why raising awareness is more important than ever. Aqsens Health’s clinical advisor and Professor of Urology Antti Rannikko answered a few questions about prostate cancer and prostate cancer screening. 

 

Prostate cancer in Finland

Associate professor and urologist Antti Rannikko from the University of Helsinki has been working with prostate cancer both in the clinical and academic world since specializing in urology in 2005. He has been at the forefront of prostate cancer research in Finland for several years, and has a unique perspective on prostate cancer burden in Finland. 

“The risk of finding prostate cancer is almost the same as a man’s age in years. That’s a rough estimate of the prevalence of prostate cancer among men, if we’d start systematically looking for it. Most men actually die without knowing they had prostate cancer, because they never had symptoms or experienced any discomfort,” Professor Rannikko notes. 

“However, some prostate cancers are aggressive and can spread outside the prostate gland, causing serious harm. This is why prostate cancer is the second leading cause of cancer death in men, right after lung cancer,” he continues.  

In Finland there are between 4,000-5,000 new prostate cancer cases yearly, with approximately 900 deaths. Globally, the number of new cases in 2018 was estimated at 1,27 million new cancer cases, with 359,000 deaths (GLOBOCAN). 

 

Unorganized = unequal

A year ago there was a bill in the Finnish parliament regarding establishing a national prostate cancer screening program, but currently a national screening program still doesn’t exist in Finland, nor in most of Europe. 

“The European Association of Urology is lobbying hard for a union wide prostate cancer screening program, or at least organized PSA-testing. There are several different viewpoints to consider,” Professor Rannikko reminds.  

A higher PSA-value in the blood can be  a sign of developing prostate cancer, but the PSA-value alone is not a reliable enough indicator to base a diagnosis on. The blood’s PSA-value is dependent on several factors like prostate size, possible infections, age or race, which is why a PSA-test must be followed by further examinations. 

We know based on a European prostate cancer screening study that PSA-testing can reduce prostate cancer mortality by 20 percent, when the patients are followed for 13 to 16 years after the PSA-test. So, lowering prostate cancer mortality using only PSA requires time. “ Rannikko explains. 

Professor Rannikko also underlines the benefits of organized screening compared to the currently used practices. 

“In Finland prostate cancer is currently being screened randomly, meaning that PSA-tests are done in basic and in occupational healthcare, but not systematically. In some occupational healthcare plans, a PSA-test might be a routine part of a normal check-up, in others it’s not. So, screening in Finland is currently very unorganized. And we know based on previous studies, that unorganized screening is not as effective as organized screening, and that unorganized screening also more often leads to over-diagnostics, false positive results and so on,” he notes. 

In addition to being more ineffective, unorganized screening  is also unequal. 

“When screening is only routinely provided through occupational healthcare, those who have no access to occupational healthcare services will automatically be left out of screening,” Professor Rannikko says.  

“The inequality is one of the reasons why in Sweden municipalities have started to implement organized PSA-testing, even though the country does not have a national prostate cancer screening program. This seems to be the aim in Europe in generaI as well” he continues.  

Aqsens Health’s AQ Prostate screening test is being developed for wide scale screening, which would enable organized prostate cancer screening and ensure more equal access to screening for all men. 

 

An innovation to improve prostate cancer prediction models

Rannikko has been a valuable advisor for Aqsens Health for the past two years, and the cooperation is set to continue in the future. In 2021, Aqsens Health, Rannikko and other collaborators began a new research project to develop a non-invasive prostate cancer screening test to accompany the currently used methods. 

The most important feature of Aqsens Health’s new prostate cancer screening test would be its ability to reliably catch the potentially lethal prostate cancer cases (Grade Groups 4–5) at an earlier stage than the current tests can, in addition to catching the less advanced prostate cancers (GG 1–2). This is something the currently widely used PSA-test is not able to reliably do. 

“The ability to differentiate between the different prostate cancer variants is very important. Let’s take pancreatic cancer and lung cancer for example. Both are well-known to be very aggressive and potentially lethal. Prostate cancer, on the other hand, has three possible variants. A significant part of prostate cancers are clinically insignificant variants that do not require any treatment. But then there are also the aggressive variants that spread outside the prostate gland and are lethal if left untreated. These are the cases we should be able to detect early, before the cancer has had time to spread,” Professor Rannikko emphasizes.  

The new non-invasive screening test would also bring added value to the clinicians by helping them to make more accurate predictions about the course of the disease. 

“With organized PSA-based screening, or with any other screening or diagnostic method, after the diagnosis it is important for us to be able to predict whether the cancer is an aggressive one that requires treatment, or a clinically insignificant cancer that merely needs monitoring,” Rannikko explains. 

Rannikko summarizes several important and time-critical questions clinicians need to consider after a prostate cancer diagnosis.

“If the prostate cancer is an aggressive variant, how should we start treating it? Will surgery be enough? Will radiation therapy be enough? Do we need to combine different forms of treatment? When the treatment begins, how will we monitor the progress? How likely is this form of cancer to come back?”

A screening test that gives as much important information as possible could be a significant help in answering some of these questions. This is why it is extremely important to be able to predict and differentiate between the different variants of prostate cancer. 

 

Taking the next steps in the development process

Aqsens Health’s non-invasive prostate cancer screening test seeks to tackle the challenges that currently prevent the establishment of a national prostate cancer screening program. 

In 2022, Aqsens Health and Professor Rannikko will move to the next stage of the test’s development, and start a clinical validation project to get the AQ Prostate test certificated according to the new EU regulative requirements (IVD-R), which will gradually come into force in the coming years.