A blood test that provides men with a score indicating their risk of having aggressive prostate cancer and reducing the need for invasive tests is now available in several provinces across Canada, thanks to donor-funded research that began 13 years ago.
For Dr John Lewis, the project lead at the University of Alberta, it all started with support from the Canadian Cancer Society (CCS). He was awarded a new investigator grant by the National Cancer Institute of Canada, the research arm of CCS before it became fully integrated into the organization.
“That first project was looking at what causes cancer spread in different cancers, including prostate cancer,” he says. “It was that funding that started off this journey and allowed us to pursue this ambitious project.”
Through that initial project, Dr Lewis’s lab discovered cancer markers they could use to improve diagnosis. Over the years, they received support from a number of different funding sources, including the former Prostate Cancer Canada, now CCS, to develop a test to diagnose prostate cancer.
ClarityDX Prostate is a test that uses an advanced machine-learning (artificial intelligence) algorithm developed at the University of Alberta and patented by Nanostics Inc., of which Dr Lewis is CEO. Based on the patient’s clinical information and prostate cancer markers in the blood, the test generates a risk score that predicts the presence of aggressive prostate cancer in less than 24 hours.
“This test can tell you if you have a low or high risk of aggressive prostate cancer,” Dr Lewis says. “It’s an addition to the PSA test and designed to give men and their doctors more clarity so they can make informed decisions about whether to proceed with a biopsy.”
PSA, or prostate-specific antigen, is a protein made in the prostate that circulates in the blood. It is measured by the commonly used PSA blood test to help find prostate cancer early. However, Dr Lewis says the PSA test is not very specific.
“Eighty per cent of the time when the PSA level is elevated, it’s not prostate cancer,” he says. “The issue is that the definitive diagnosis of prostate cancer comes from a biopsy, which is a pretty invasive procedure.”
In their recent publications in Nature Digital Medicine and Cancer Medicine, the team highlights how ClarityDX Prostate was able to predict with 95% accuracy who had aggressive prostate cancer. The researchers say that the test is up to 4 times more accurate than PSA testing alone in predicting aggressive prostate cancer. Not only that but using the test could reduce unnecessary biopsies by up to 47% and significantly reduce the number of unnecessary treatments for prostate cancer.
When Todd first found out his PSA level had spiked, “I was concerned,” he recalls. “I was freaking out.”
He began searching medical journals on Google to learn more about it. At one point, faced with long wait times to see a urologist in Canada, Todd even considered going abroad for help.
But once he learned about ClarityDX Prostate from Dr Pink, Todd shared the information with his doctor who helped him to take the test. His result showed that at the age of 54, he is in the middle range of the low-risk bracket for aggressive prostate cancer.
“What that test does is it gives you a much better feeling of where you fit in the risk profile,” Todd says. “I understand my situation much clearer now. It has calmed me down and made me understand that I don’t need a biopsy. If I hadn’t taken the test, I would have lived with the fear of not knowing what was happening.”
“If nothing else, it’s an awareness that brings comfort if the results are positive,” John says. "It encourages you to take the next step. For me, I want to continue to be in a leadership role, rather than simply a patient in a follower role. ClarityDX Prostate helped with establishing that confidence."
With an active lifestyle at age 72, John, an avid motorcyclist, is working with his medical team on treatment options. In the meantime, he is looking forward to going on motorcycle trips with his “Harley friends."
The ClarityDX Prostate test is currently available in Alberta, British Columbia, Ontario, Quebec, and Saskatchewan. It costs $300 to take the test, but Dr Lewis and his team are working with the government to reimburse the costs.
“We really feel that this test should be free for patients and incorporated as part of the healthcare system,” Dr Lewis says. “When you are avoiding up to 47% of biopsies, which are very expensive, using ClarityDX Prostate could save the Canadian healthcare system between $20-40 million per year. That’s a pretty significant cost-savings to the system.”
The next step for Dr Lewis’s team is to make the test available beyond Canada.
To learn more about how CCS is investing in promising cancer research, check out our research strategy.