FDA gives nod to tumor cell test for monitoring metastatic PCa

March 13, 2008

The FDA has approved an expanded clearance for the CellSearch System to be used as an aid in monitoring patients with metastatic prostate cancer. The system currently is cleared for monitoring metastatic breast and colorectal cancer patients.

The FDA has approved an expanded clearance for the CellSearch System to be used as an aid in monitoring patients with metastatic prostate cancer. The system currently is cleared for monitoring metastatic breast and colorectal cancer patients.

The product identifies and counts circulating tumor cells in a blood sample to predict progression-free survival and overall survival in patients with metastatic prostate cancer and can do so earlier than the current standard of care, according to its manufacturer, Veridex, of Warren, NJ.

“We have compared CellSearch circulating tumor cell test results to the standard clinical and biomedical parameters, such as PSA, measured in metastatic prostate cancer patients,” said Nick Vogelzang, MD, of the Nevada Cancer Institute, Las Vegas. “A decrease in the number of circulating tumor cells is most often associated with patients successfully responding to therapy. Further analysis of circulating tumor cells may provide information as to the most efficacious treatments for specific individuals.”

A prospective, multicenter study was conducted in 65 clinical centers in the United States and Europe and included 231 metastatic prostate cancer patients about to enter first- or later-line chemotherapy. Data showed that patients with less than five circulating tumor cells at baseline had significantly better survival rates than did patients with more than five circulating tumor cells.

Data also showed that circulating tumor cells are a strong independent predictor of progression-free survival and overall survival, and that the combination of circulating tumor cell analysis and PSA assessment may provide the most accurate assessment of prognosis.

Dr. Vogelzang is the recipient of a research fellowship grant from Veridex for the purpose of supporting independent research in metastatic prostate cancer patients.