Publications

Furthering the prostate cancer screening debate (prostate cancer specific mortality and associated risks).

By:
Contributors: Bryan Donnelly, MD, MSc, FRCSC, Dean Ruether, MD FRCSC, Michael Chetner, MD, MSc, FRCSC, FACS, Peter Venner, MD, FRCPC
Can Urol Assoc J. 2011 Dec;5(6):416-21. doi: 10.5489/cuaj.11063.

Abstract

Screening for prostate cancer remains a contentious issue. As with other cancer screening programs, a key feature of the debate is verification of cancerspecific mortality reductions. Unfortunately the present evidence, two systematic reviews and six randomized controlled trials, have reported conflicting results. Furthermore, half of the studies are poor quality and the evidence is clouded by key weaknesses, including poor adherence to screening in the intervention arm or high rates of screening in the control arm. In high quality studies of prostate cancer screening (particularly prostatespecific antigen), in which actual compliance was anticipated in the study design, there is good evidence that prostate cancer mortality is reduced. The numbers needed to screen are at least as good as those of mammography for breast cancer and fecal occult blood testing for colorectal cancer. However, the risks associated with prostate cancer screening are considerable and must be weighed against the advantage of reduced cancerspecific mortality. Adverse events include 70% rate of false positives, important risks associated with prostate biopsy, and the serious consequences of prostate cancer treatment. The best evidence demonstrates prostate cancer screening will reduce prostate cancer mortality. It is time for the debate to move beyond this issue, and begin a well-informed discussion on the remaining complex issues associated with prostate cancer screening and appropriate management.

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ClarityDX Prostate clinical study expanding to the United States

Oct 8, 2019: APCaRI and Nanostics Inc. are excited to announce the opening of the first recruitment site in the US for the ClarityDX Prostate clinical validation study with Century Clinical Research Inc., based in Daytona Beach, Florida. ClarityDX Prostate is a novel liquid biopsy test for the early diagnosis of clinically significant prostate cancer.

The clinical validation study targets the recruitment of 2,800 patients with elevated levels of PSA. Therefore, US recruitment will significantly accelerate the clinical study timeline and increase patient cohort diversity.

Funding support to include US patients comes from the Bird Dogs for Prostate Cancer Research, Alberta Cancer Foundation, Alberta Innovates-ASBIRI program and the University of Alberta. The US and Canadian study samples will continue to be processed in partnership with DynaLIFE Medical Labs in Edmonton, Alberta.

“We’re very happy to partner with Century Clinical Research to recruit US men to our study,” John Lewis, CEO of Nanostics said, “the Florida recruitment site will help us increase the regional diversity of our cohort and strengthen the results of our ClarityDX Prostate study, ultimately, allowing us to make the test available to men across North America.”

“Our extensive clinical trial research experience and diverse patient population in Daytona Beach makes us a perfect partner…” said Thomas Gaskin, Vice-President & CFO of Century Clinical Research, Inc., “we look forward to working with Nanostics to develop their ClarityDX Prostate test to help improve prostate cancer outcomes.”

Implementing ClarityDX Prostate may eliminate up to 600,000 unnecessary biopsies, 24,000 hospitalizations and up to 50% of unnecessary treatments for prostate cancer in North America. This equates to a projected $1.4B per year in cost savings to healthcare and a dramatic impact on the healthcare experience and quality of life for men.

About Century Clinical Research, Inc.
Century Clinical Research, Inc. has over ten years of clinical research experience in multiple specialties, including hematology and oncology. Our staff has completed numerous industry-sponsored clinical trials in phases II-IV and has an excellent track record in quality completion of critical trials. Century Clinical Research, Inc. offers a full research infrastructure and our research staff has been trained in electronic data capture with multiple sponsors. We use a computerized clinical research program for tracking study participation and regulatory documents.
Website: https://www.centuryclinical.com/century_clinical_research.html

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