A Canadian-based clinical trial testing a novel liquid biopsy test for the early diagnosis of clinically significant prostate cancer has entered the United States for the participation of Daytona Beach’s Century Clinical Research Inc.
Called the ClarityDX Prostate test, the investigational product is developed by Nanostics Inc. and co-sponsored by Alberta Prostate Cancer Research Initiative (APCaRI).
The main objective of the study is to validate ClarityDX Prostate as a reflex test to PSA to refine the prediction of clinically significant prostate cancer in a prospective cohort of men to be recruited in Alberta, Whitehorse, and the United States when patients are scheduled for a biopsy as a result of an elevated PSA.
A prospective training and validation cohort study, the western Canadian sponsors seek up to 2,800 consenting men in total from ages 40 to 75 without prior diagnosis of prostate cancer, who have been selected to undergo a prostate biopsy to rule out prostate cancer.
Expansion to Accelerate Timeline—the Hope
The sponsors report that an expansion to America will accelerate the study’s timeline. When the sponsors initiated the study during the summer of 2019, they were recruiting from two sites including 1) Prostate Cancer Centre in Alberta and 2) Northern Alberta Urology Centre in Alberta. Both of these cities combined equals about 3.2 million population.
With the addition of Century Clinical Research, the Canadian sponsors tap into another population of nearly a million in the Deltona-Daytona Beach-Ormond Beach, Florida Metropolitan Statistical Area.
Funding for Expansion
Sponsor Nanostics Inc. is a privately held venture owned by founders and a small group of investors. The funds to expand to the U.S. originate from the Bird Dogs for Prostate Cancer Research, Alberta Cancer Foundation, Alberta Innovates-ASBIRI program and the University of Alberta.
The Investigational Product: What is the Value Proposition?
The sponsor’s press release touts the potential impact of the ClarityDX Prostate test is considerable—implementation could eliminate up to 600,000 unnecessary biopsies, 24,000 hospitalizations and up to 50% unnecessary treatments for prostate cancer in North America. The sponsors estimate a theoretical cost savings of $1.4+ billion! Moreover, quality of life, a considerable element, will increase for men experiencing prostate cancer evaluation.
The American Site: Century Clinical Research Inc.
Century Clinical Research has entered the study to accelerate the study timeline. With access to a diverse patient population, they appear to be a motivated research site—clearly this type of site is needed for successful studies especially when the timelines are slipping due to lack of patient enrollment.
They declare on their website to offer staffed primary investigators along with clinical research coordinators not to mention staff and process adhering to FDA, GcP and ICH guidelines. In the press release they are noted to have successfully completed numerous industry-sponsored clinical trials in phases II-IV and “an excellent track record in quality completion of critical trials.”.
The Florida-based site touts multiple specialties from internal medicine, cardiology and dermatology to infectious disease, pain management, nephrology and more. They note their staff is trained in electronic data capture with multiple sponsors and that they “utilize a computerized clinical research program for tracking study.” They also promote their facilities which include an array of diagnostic and clinical equipment from freezers (-86 º Celsius), Centrifuge, Ambulatory Monitoring, compliant drug storage, etc.
Founded in 2004, they employ approximately 12 and they offer both a family medicine practice and a clinical investigational site operation. Revenues are estimated in Buzzfile at just under $900,000. The management appears to be related at the key contact is Tina Gaskin, a Nurse Practitioner, while Thomas Gaskin, quoted in the sponsor’s press release, serves as their CFO.
FDA Inspection as Part of Arthritis Pain Patch Study
In 2013, as part of an NDA filing (22-029/ S-012) for an arthritis pain patch product (SALONPAS®) the FDA conducted a Clinical Review by a Ryan Raffaelli, MD. For the single efficacy study supporting the sponsor’s NDA the FDA requested audits of three individual sites and the CRO involved by the inspectors of the Office of Scientific Investigation. Century Clinical Research was one of the three sites and happened to be one of “highest enrollers” meaning they recruited more patients than other sites. During this inspection the FDA issued a Form 483 for violations of data management.
Although we cannot control what individuals say on social media, such as Facebook or review sites such as Glassdoor or Yelp and often there are some real bad apples out there, TrialSite News research does review comments on social media sites often. We have experience with various “social listening” methodologies and apply when reviewing clinical investigational sites. This, by no means, can be a determinant of the quality of the actual operation.
The Sponsor: Nanostics Inc.
Founded by professor John Lewis of University of Alberta, Lewis is the Frank and Carla Sojonky Chair in Prostate Cancer Research at the university. Lewis formed the privately held venture in 2017 focusing on the development and commercialization of novel and non-invasive diagnostic tests. The company positions that their core technology can diagnose disease from a simple blood test by combining a highly sensitive extracellular vesicle (EV) detection platform with advanced machine learning algorithms. They report that their novel technology is applicable to a wide range of cancers and other diseases. Their lead products include ClarityDX Prostate—and they declare it will become the first clinically validated test using their underlying EV detection technology.
Call to Action: If you are interested in a novel liquid biopsy test for the early diagnosis of clinically significant prostate cancer, then it makes sense to track this study. Sign up for TrialSite News Daily Digest, and we will update you as well.Source: EurekAlert!