With seven Olympic medals to his name – six of which are gold – Chris Hoy is one of the greatest athletes in British History. But the Scotsman, who was bestowed a knighthood in 2008, was in the news for very different reasons recently, after he revealed a terminal prostate cancer diagnosis.
Support poured in for the retired track cyclist, but a significant consequence was the jump in the number of men seeking prostate cancer advice. Hoy called for more men in their 40s to be screened to detect possible cancers early – a view which was noted by the UK’s Health Secretary Wes Streeting.
Currently, NHS guidelines for England say anyone can request a prostate-specific antigen (PSA) test if they are over the age of 50. However, there is currently no national screening programme for prostate cancer in the UK because there is no reliable test that can detect the illness requiring treatment at an early stage. Following Hoy’s comments, the NHS said it would review its advice on testing for prostate cancer.
Chiara De Biase, director of health services, equity and improvement at charity Prostate Cancer UK, said in a statement that “the system needs to change”, adding that the government needs to “overhaul outdated NHS guidelines” to ensure earlier PSA tests.
In an International Men’s Day debate by the UK Parliament on 21 November, Calvin Bailey, Labour MP for Leyton and Wanstead, said that “the need for faster diagnosis and more effective treatment of prostate cancer is a serious problem for men, and I am looking forward to addressing that in the coming months”.
Although it is one of the most common cancers in men, prostate cancer is treatable if caught early. The PSA test is the current go-to treatment and has been the gold standard for more than 30 years. As with all diagnostics in healthcare, however, technologies are improving. Medical Device Network looks at what’s on the horizon and what their long-term prospects of use in healthcare systems look like.
The specificity problem
Though the use of PSA tests is widespread, its key limitations are the false-positive and false-negative rates. Around 75% of people with a raised PSA level have a negative prostate biopsy while 15% of asymptomatic people with a normal PSA level may have prostate cancer. The former might lead to unnecessary stress and further investigations, whilst the latter gives an incorrect account of absent cancer.
Results from a 400,000 patient-strong study published in the Journal of the American Medical Association in April concurred with this. Evidence from the 15-year trial suggested screening has a small impact on reducing deaths and can conversely lead to men being incorrectly diagnosed with cancer. Data such as this factors into why many countries do not have national screening programmes.
There’s a lot of promise around GRAIL-Galleri – a blood-based test that looks for DNA fragments in the blood that have broken off from cancer cells. As a type of circulating tumour DNA (ctDNA) test, it could provide an upgrade in terms of specificity across multiple cancer types.
Findings from the Circulating Cell-free Genome Atlas study (NCT02889978) show that the test was highly accurate at ruling out cancer, correctly identifying 99.5% of the people without the disease. However, it too had a limitation with prostate cancer – correctly identifying just 11% of patients with the disease. In essence, 89% of men with cancerous cells in the prostate were missed.
The test is only available in the US by prescription but the NHS is conducting a large study with the test involving 14,000 volunteers to assess whether to roll out the test. Results from the study are expected in 2026, upon which the NHS will decide.
The Galleri test costs $949, along with a small blood draw fee, meaning most insurances in the US do not cover the test. Medicare, which does not reimburse the test normally, is conducting a 50,000-participant study in participants aged 50 and older where it will cover the costs of the test to assess real-world clinical impacts.
Despite insurance limitations, GRAIL is posting strong financial performance. The company recorded Q2 2024 revenues of $32m, up 43% from the same period last year.
Prostate Cancer UK says the data for the illness “remains uncompelling”. The charity has launched its own £42m trial to compare the most promising tests.
In June, researchers from the Institute of Cancer Research (ICR) and the Royal Marsden National Health Service (NHS) Foundation Trust shared findings from its own promising approach, a saliva-based test for those at high risk of prostate cancer. The cheap and simple spit test could identify men at higher risk due to their genetic makeup, said Ros Eeles, principal investigator of a study evaluating the test.
Aggressiveness of prostate cancer
Since the survivability of prostate cancer is directly correlated with when the cancer is found, a test that determines the aggressiveness of tumour cells would mark a significant leap in treatment pathways. Indeed, current tests for prostate cancer cannot differentiate between cancers that might not grow enough to cause harm and aggressive ones that need immediate treatment.
The University of Birmingham’s Professor Paula Mendes is heading up a programme investigating the use of nanoparticles to test for specific proteins which indicate that the cancer is aggressive.
“PSA exists in 56 different glycoforms. This is the same protein but with different sugars attached to it. What we know from glycoproteomics is that about four are indicative of a man with aggressive prostate cancer. PSA tests measure all 56 glycoforms, a more accurate test would be to look at markers indicative of aggressive cancer,” said Mendes.
The team designed nanoparticles that specifically bind to the types of PSA sugars that are linked to aggressive prostate cancer. When attached to these sugars, the nanoparticles emit a coloured light. The team has tested this new technology, which can be recreated at large with low costs, using samples from men with slow-growing or aggressive prostate cancers.
“The hurdle is to develop a test that detects in an accurate and cost-effective manner. We had to do important market research for our test in terms of financial considerations.”
Their work is showing early promise and has caught the eye of prostate cancer groups, with Prostate Cancer UK awarding Mendes and her team a grant worth more than £275,000. Mendes says the long-term aim is for their technology to replace PSA testing.
Imaging’s integral role
Away from techniques on a cell surface level, the deployment of magnetic resonance imaging (MRI) is significant in prostate cancer diagnosis.
Currently, doctors offer patients an MRI scan when a cancer is suspected to have spread beyond the prostate. In most situations, the scan is conducted before a biopsy is taken from the patient.
An ongoing study by researchers at the University of Gothenburg is evaluating whether the combination of PSA testing followed by MRI can reduce overdiagnosis whilst maintaining detection of clinically significant cancer.
“Previous research has shown MRI improves sensitivity. It also reduces unnecessary biopsies and makes biopsies more efficient with the optimum number of samples per patient. MRI will be a great companion to PSA,” says Angel Alberich-Bayarri, CEO of Quibim.
Quibim has developed an AI-powered tool that helps to automatically detect prostate cancer lesions. Alberich-Bayarri sees the market moving towards an integration of detection technologies with targeted therapies. This, he adds, is why MRI’s importance could grow significantly as treatments advance.
“You need to know where to attack and, in our case for example, we are obtaining that map automatically from the AI, and it makes sense that detection is integrated with the focal therapy.”
Speaking on the use of AI in prostate cancer diagnosis, Alberich-Bayarri is optimistic.
“I see a limitless scenario. Models will be able to train on growing datasets which can improve sensitivity and specificity. We are doing a project on a digital twin of the prostate, for example. In years to come, I am sure we will see MRI plus AI in prostate cancer for asymptomatic patients, heading to a preventative scenario.”
GlobalData strategic intelligence analyst Shabnam Pervez says AI is improving diagnostics by “increasing accuracy, speed, and accessibility”, adding that for prostate cancer, the technology can “identify any subtle anomalies that may be missed by the human eye”, which allows earlier detection and treatment plans.
Beyond imaging, AI can also be used to “analyse genetic data to identify risk factors and predict disease progression, enabling personalised treatment plans,” she adds.
And while it may indeed have limitless potential, Pervez said addressing challenges is crucial in ensuring its “responsible and effective implementation in clinical settings”.
“AI in cancer diagnostics faces limitations such as data quality, interpretability, ethical concerns, and regulatory hurdles. Most importantly, it requires a great deal of human trust, diligence, and training, which can take time.”
With more of an emphasis on earlier MRIs, initial costs will increase. However, researchers are already looking at ways to improve cost efficiency. As part of a trial called PRIME involving 555 patients from 22 hospitals in 12 countries, researchers from University College London (UCL) and University College London Hospitals assessed the impact of dropping one of the three stages of the MRI.
The study demonstrated that using the shorter scan allowed specialists to diagnose 29% of prostate cancers – the same proportion as with three-step scans, which reduces cost and makes scans more accessible.
“This will allow more men to benefit from a better, more accurate diagnosis at a lower cost to healthcare systems not only in the UK but worldwide,” said Matthew Hobbs, director of research at Prostate Cancer UK in a statement at the time.
The effects of Sir Chris Hoy revealing his prostate cancer diagnosis have been remarkable – a nearly eight-fold increase in NHS searches for symptoms of the disease is evidence enough. Diagnostics have already advanced rapidly over the past few decades to accompany more men seeking health checkups – whether these tests can overcome barriers to become screening mainstays in healthcare systems is another question entirely.
