Evolution In Prostate Cancer Diagnostics Creates New Opportunities For Medtech
Posted April 18, 2019| Laura Ruth, PhD , Syed Shehab MD
In the US, prostate cancer remains a challenge for men’s health, with approximately 174,650 new cases expected in 2019, third behind only breast cancer (271,270 new cases expected in 2019) and lung cancer (228,150 new cases), according to the National Cancer Institute’s (NCI) recent review of common cancers.
Even with its frequency, the current diagnostic landscape for prostate cancer is imprecise, because the initial prostate cancer screen sets off a cascade of events and often leads to unnecessary and inaccurate biopsies. One million prostate biopsies are performed in the US every year, but only 25 percent of the men who undergo a prostate biopsy, due to an elevated PSA, have high-grade prostate cancer. This practice has amounted to USD $1.3B in unnecessary spending in the US since 2012. The overuse of biopsying, in turn, leads to over-diagnosis and over-treatment of the disease — even leading to unnecessary prostatectomies.
However, it’s important to note that the number of men with prostate cancer surviving beyond five years post-diagnosis is more than 98 percent. This staggering high percentage of patients drives the need to develop sensitive and specific biomarkers to monitor treatment response and possible recurrences of the disease. Because prostate cancer diagnostics remains an area of unmet medical need — with the potential to offer substantial cost savings to health systems and better quality of life to patients — we provide a high-level review of some of the existing prostate cancer diagnostic assays used for screening, risk stratification, and monitoring treatment response. We also discuss opportunities for development in prostate cancer diagnostics.
Dissecting the Prostate Cancer Diagnosis Landscape
Currently, the three critical prognostic biomarkers used to diagnose prostate cancer are:
- the clinical stage of the patient, based on the tumor, node, metastasis (TNM) system
- Gleason score (grade of the tumor, based on the biopsy)
- the pretreatment serum prostate-specific antigen (PSA) level
The Union for International Cancer Control (UICC) and the American Joint Committee on Cancer (AJCC) have used the above variables to define prognostic groups and to predict the probability of biochemical failure after definitive local therapy, and consequently select the best therapeutic approach.