Prostate cancer will be diagnosed in 210,000 men in 1997 according to the American Cancer Society. The current strategy for initial diagnosis is a visit to the family physician for a digital rectal exam and a serum PSA test for men over the age of 50 and in some instances over the age of 45. A large population of men present-with a PSA between 4-10 ng/ml and only about 30% of these will be confirmed by biopsy as cancer. Thus, numerous biopsies are done unnecessarily. The seminal fluid test is a rapid assay assessing the status of prostate epithelial cells by flow-cytometry and specific antibodies to prostate cancer antigens. This feasibility of this assay as a complement to the PSA test will be determined.Proposed Commercial Application:210,000 new cases of prostate carcinoma will be diagnosed in 1997. While serum PSA has improved screening, more sensitive and specific means are needed to confirm diagnosis in certain groups of individuals. It is recommended that all men over 50 be screened. A diagnostic seminal fluid test which was more accurate could improve screening and obviate more costly confirmatory procedures and tests. The commercial application of such a test would be vast.
Thesaurus Terms:diagnosis design /evaluation, diagnostic test, neoplasm /cancer diagnosis, prostate neoplasm, semen antibody specificity, benign prostate hyperplasia, prostate specific antigen, prostatitis, rapid diagnosis clinical research, cytology, flow cytometry, human subject, maleNATIONAL CANCER INSTITUTE
