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| |  ProstaScint More Effective At Detecting Prostate Cancer Metastases PRINCETON, NJ -- December 21, 1999 -- Cytogen Corporation announced that a leading medical journal has published the results of a clinical study of ProstaScint(R) in which the authors concluded that the company's prostate cancer diagnostic was better at detecting metastases than standard imaging techniques in pre-surgical patients of moderate to high risk for spread of disease. The company had used the results from this Phase III clinical trial to support its successful Product License Application to the U.S. Food and Drug Administration in 1995. A detailed presentation of the data from the company-sponsored clinical investigation appears for the first time in the current issue of the journal Urology 54 (6) 1058 - 1063.
Prior to the introduction of ProstaScint, there was no noninvasive diagnostic test that reliably identified whether a patient's cancer was confined to the prostate gland or whether it had metastasized or spread to lymph nodes. This study in 152 evaluable patients at 24 medical centers showed that imaging with ProstaScint radio-labeled monoclonal antibody correctly identified the spread of prostate cancer in 62 percent of patients, as compared to lymph node biopsy, whereas, computed tomography (CT) and magnetic resonance imaging (MRI) were specific only 4 percent and 15 percent of the time, respectively. In addition, immunoscintography with ProstaScint detected lymph node lesions in 38 patients that were not detected by any other diagnostic test but subsequently were confirmed to be malignant. In a more recent comparison of ProstaScint in combination with clinical staging algorithms by Polascik et. al. 1999, Cancer 85: (1586-92), the authors concluded yet higher positive predictive values of 72 percent could be obtained. "The results of this study demonstrate that ProstaScint accurately identified lymph-node metastases in patients who were at increased risk of their cancer having spread beyond their prostate," said Michael J. Manyak, M.D., Professor and Chairman, Department of Urology, George Washington University Medical Center, and lead author of the paper. "ProstaScint imaging proved to be the best single predictor of lymph node metastases in this population of men." "The data are continuing to mount in support of the clinical relevance of ProstaScint," said H. Joseph Reiser, Ph.D., Chief Executive Officer of Cytogen Corporation. "We believe that our product is an important staging tool for making clinical decisions in the management of patients with prostate cancer." ProstaScint is currently approved as a diagnostic imaging agent indicated for the staging of newly diagnosed prostate cancer patients who are at high risk for lymph-node metastases. ProstaScint is also indicated in patients with recurrent disease who have failed primary therapy for prostate cancer, as determined by rising levels of prostate-specific antigen (PSA) levels, but for whom the site of recurrence is unknown.
Related Link: Cytogen Corporation.
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