Prostate Cancer Campaigns Boost Enrollment in Study to Validate ClarityDX Diagnostic Test in Canada

Campaigns by Movember and the Alberta Cancer Foundation have helped to raise the number of men enrolled to more than 200 in the validation study of ClarityDX Prostate, a new blood screening test developed by Nanostics for the early diagnosis of prostate cancer.

Recruitment, which started in June this year, got an additional boost in November, thanks to the “Grow a Mo” (moustache) and GivingTuesday 2019 campaigns run by the two Canadian charities.

“We are overwhelmed by the support we’ve received from people all over Alberta as we work to validate the ClarityDX Prostate test,” John Lewis, Sojonky chair in prostate cancer research at the University of Alberta and CEO of Nanostics, said in a press release.

“Improving the accuracy of prostate cancer screening will have a significant impact on men and their families in this province and beyond,” he said.

Movember is known internationally for raising funds to advance research in prostate and testicular cancer, as well as for mental health and suicide prevention in men. This November, it launched its annual “Grow a Mo” campaign to help raise awareness and funds.

The Alberta Cancer Foundation is the largest charity dedicated to cancer research and care in the province of Alberta, Canada, and is supported by donors. In its GivingTuesday 2019 campaign, donations tripled their impact, thanks to matching gifts by two Alberta families who have each offered $50,000 to the foundation.

ClarityDX Prostate is a noninvasive blood test designed to detect clinically significant prostate cancer early and help guide doctors on which patients to refer for biopsy. The test was designed both for diagnosis and for active surveillance, or watchful waiting, to see if patients progress to clinically significant cancer.

The tool uses Nanostics’ ClarityDX platform, combining machine learning with detection of extracellular vesicles — small vesicles, or fluid-filled sacs, released from cells that may contain disease-specific markers.

The ClarityDX test could have a dramatic impact on men’s healthcare and quality of life, according to Nanostics. Its implementation could eliminate up to 600,000 unnecessary biopsies and 24,000 hospitalizations, and cut unneeded treatments for prostate cancer by half in North America. This could potentially save more than $1.4 billion per year in healthcare costs.

Nanostics is conducting a pivotal trial (NCT03957252), which is co-sponsored by the Alberta Prostate Cancer Research Initiative and DynaLIFE Medical Labs, to validate ClarityDX’s diagnostic value.

The study will recruit 2,800 men, 40 to 75 years old, who have elevated prostate specific antigen levels — or between 3 and 10 ng/mL — and who have been selected to undergo prostate biopsy to rule out prostate cancer. Participants will have the ClarityDX Prostate test performed at DynaLIFE Medical Labs in Edmonton, Alberta.

Patients will first be recruited at Calgary’s Prostate Cancer Centre and Edmonton’s Northern Alberta Urology Centre, in Alberta, and later at centers in the Yukon Territories.