Prognostic Test Monitors Postoperative Prostate Cancer Patients

A diagnostic test will enable physicians to monitor the prognosis of cancer patients after radical surgery and estimate the risk of recurrence.

The in vitro diagnostic assay was developed using new technology. The test, a nucleic acid detection immunoassay, enables physicians, after clinical evaluation, to predict the prognosis of prostate cancer patients post radical prostatectomy and estimate the probability of recrudescence.

The test, NADiA ProsVue, was developed by IRIS International (Chatsworth, CA, USA) from the company's platform technology for the ultrasensitive detection of proteins that are signals for cancer and infectious diseases. To establish a prognostic indicator algorithm, clinical trials with NADiA ProsVue as the predictive test used serum samples collected over a period of 18 months. The test were held at Duke University, (Durham NC, USA), the University of Washington, (Seattle, WA, USA), Eastern Virginia Medical Center, Norfolk, VA, USA), and Memorial Sloan-Kettering Cancer Center, New York, NY, USA).

The results of the retrospective study of 300 patients' postprostatectomy who were either stable or had recurring prostate cancer were combined and compared with previous studies at Mt. Sinai Hospital (Toronto, Canada) and Duke University at the suggestion of the US Food and Drug Administration (FDA; Silver Spring, MD, USAv). The clinical study was able to classify 228 patients as stable and 72 as recurring. Application has been made for FDA approval of the test.

The incidence of new cases of prostate cancer in the U.S. in 2009 was 192,280 with a 14.2% mortality rate. Over 2 million men have had a radical prostatectomy, and while 85,000 operations of this type are performed every year, nearly 30% may have a recurrence within the 10 years following the procedure.

Thomas Adams, Ph.D., corporate vice president and chief technology officer of IRIS, stated, "The high sensitivity of the test has the potential of a significant advance in cancer relapse prognosis .This would lead to better remedial consequences and reducing unnecessary treatment, considerably lowering healthcare costs".

Related Links:
IRIS International
Duke University
University of Washington
Eastern Virginia Medical Center
Memorial Sloan-Kettering Cancer Center
Mt. Sinai Hospital, Toronto, Canada
US Food and Drug Administration