A new experimental test for prostate cancer may eliminate the need for tens of thousands of biopsies and detect cancers previously missed by the test that is currently the most commonly used. According to reports, the serum test is highly effective for the early detection of prostate cancer. According to research, the new EPCA-2 serum test is sensitive to prostate cancer and highly specific.
The results of an initial, large-scale research study showing the accuracy of the new test have been published in the medical journal, Urology. Medical professionals often review the journal.
The new test was developed at Johns Hopkins University and the University of Pittsburgh, with help from a grant from Oncome Incorporated. Oncome Incorporated has exclusive worldwide rights to the new test, which may detect prostate cancer and eliminate the need for many biopsies. Work on the test is being done in company laboratories, for clinical trials and FDA approval.
PSA is the test currently used the most often to detect prostate cancer. PSA measures a protein produced by the prostate. The experimental EPCA-2 detects a chemical that is usually made by cancerous tissue.
About 80 percent of prostate biopsies detect no tumor, even though a patient has been referred for the biopsy. That percentage is rising, as doctors are more aggressive in searching for the disease.
Robert H. Getzenberg, a molecular biologist at Johns Hopkins Hospital, and the developer of the new test, said he hopes the EPCA-2 serum test will “minimize the number of unnecessary biopsies.”
Physicians are often unsure how to detect or treat prostate cancer. Prostate cancer is also the most common cancer in men. The American Cancer Society reports that more than 200,000 new cases of the disease will be found in 2007. More than 27,000 American men will die from the disease.
Currently the PSA test looks for a blood protein called prostate-specific antigen (PSA). If the PSA is above a certain level (2.5 nanograms per milliliter), men are referred for a biopsy to verify if cells contain cancer.
According to doctors there are three problems with the PSA test: 1. It has a high level of false positives. Most of the biopsies come back normal. Professor Getzenberg said 80 percent of the 1.6 million American men for biopsies return with negative results. 2. It also has a high level of false negatives. It fails to detect cancers with a low level of PSA. Professor Getzenberg says 15 percent of men with prostate cancer fail to learn of their disease because of the low level of PSA. 3. It can’t tell if the cancer has spread to other parts of the body.
Researchers believe the new test will improve screening and testing on all three levels.
“A blood test based on EPCA-2 may greatly improve our ability to accurately detect prostate cancer early and minimize the number of false positives, therefore lowering the number of unnecessary biopsies,” Getzenberg said of the test in a prepared statement.
“This is the first time we have a test that effectively distinguishes between men with cancer confined to the prostate and those whose disease has spread outside of the gland,” the professor added.
Testing at Johns Hopkins was done on: men with normal PSA who had prostate cancer; men with normal PSA who did not have cancer; men with elevated PSA but negative biopsies; men with a noncancerous prostate condition called benign prostatic hypertrophy (BPH) who did not have biopsies; men with prostate cancer that had not spread; men with prostrate cancer that had spread elsewhere; patients with benign conditions of other organs; and patients with other types of cancers.
The results were encouraging. The tests detected 97% of patients who did not have cancer. The test detected 94% of the men with cancer.
The study of the new test that may eliminate the need for thousands of biopsies and detect cancers previously missed was funded by National Cancer Institute of the National Institutes of Health, and Onconome Inc. Getzenberg is employed by Oncome Incorporated as a consultant and will receive royalties from the new product.