Health Canada (Commonwealth Union) – Prostate-specific antigen (PSA) blood tests and digital rectal exams (DRE) are commonly used for screening and early detection of prostate cancer. Elevated PSA levels or abnormalities detected during a DRE usually lead to further diagnostic tests, such as a prostate biopsy.
In the state of Alberta, men with elevated levels of PSA now have access to a novel blood test to assess their risk of clinically significant prostate cancer, potentially sparing them from unnecessary biopsies.
The PSA blood test serves as the standard screening tool for prostate cancer. Typically, when a patient’s PSA levels are elevated, a biopsy is ordered to confirm the presence of cancer. However, elevated PSA levels can sometimes result from non-cancerous factors such as age, infection, or an enlarged prostate. Additionally, it can be indicative of lower-risk prostate cancer that may not necessitate immediate treatment. This new test is now available to provide patients and their physicians with additional information, enabling them to make well-informed decisions regarding whether a biopsy is warranted.
“The ClarityDX Prostate test will reduce the number of unnecessary prostate biopsies, which are invasive, uncomfortable and carry some risk,” explained John Lewis, Bird Dogs Chair in Translational Oncology at the University of Alberta, who is also CEO of Nanostics Inc., which is a University of Alberta (U of A) spinoff company.
The recently introduced test marks a groundbreaking achievement as the first product originating from technology developed at the University of Alberta and patented by Nanostics. This cutting-edge technology assesses the levels of prostate cancer biomarkers present in a patient’s blood sample, integrates this data with their clinical information, and employs machine learning to generate a predictive risk score for the presence of clinically significant prostate cancer.
In a recently published study, the Lewis research team scrutinized the outcomes for 415 men from Alberta who had been referred to urology clinics for biopsies due to elevated PSA results between 2014 and 2017. Remarkably, the ClarityDX Prostate test exhibited a remarkable 95 percent accuracy in predicting which patients had high-grade, clinically significant prostate cancer necessitating treatment. Notably, 35 percent of these patients could have potentially avoided the recommended biopsies as they did not have clinically significant cancer.
Furthermore, in an additional yet unpublished clinical validation study encompassing 3,448 participants from Alberta and the United States, the test exhibited a threefold higher accuracy rate compared to the standard PSA test in detecting clinically significant prostate cancer. The research team also emphasized that implementing this test could potentially reduce the need for up to 37 percent of unnecessary biopsies and significantly decrease unnecessary treatments for prostate cancer.
Prostate cancer is the most prevalent form of cancer diagnosed among Canadian men, with one in eight men receiving this diagnosis during their lifetime. Tragically, one in 29 will succumb to prostate cancer, rendering it the third leading cause of cancer-related mortality among Canadian men, according to data from the Canadian Cancer Society.
While the test is presently not covered by the Alberta health care insurance plan, Nanostics is in the process of seeking approval for coverage. Additionally, the company is pursuing regulatory approvals from Health Canada and the U.S. Food and Drug Administration to expand the distribution of this groundbreaking test.
The Lewis research team is already actively engaged in the development of a predictive test for bladder cancer using the same technology. Furthermore, they envision the potential to create diagnostic tools for various other illnesses, including cardiac diseases, infectious diseases, and neurodegenerative disorders.
This research was a collaborative effort involving the Lewis laboratory, Nanostics, and the Alberta Prostate Cancer Research Initiative. Funding for the project was generously provided by Alberta Innovates, the Alberta Cancer Foundation, the Bird Dogs Cure Cancer Foundation, the Edmonton Motorcycle Ride for Dad, and the Prostate Cancer Foundation Canada.
