The long term goals of this project ar to: 1) develop a sensitive and accurate diagnostic urine test for prostate cancer; and, 2) create a "prostate profile" identifying prognostic subgroups of prostate cancer based on expression of molecular markers. We detected in urine sample the expression of specific genetic markers which appear in men with prostate cancer. This Phase I application will determine the feasibility of utilizing this test as a diagnostic and/or prognostic indicator in prostate cancer. We will initially optimize the collection of urine specimens with respect to cellular viability and RNA quality and quantity. Next, we will evaluate at least 100 additional urine specimens for specific gene expressions and, finally evaluate the relationship of laboratory data and clinical data for interpretation and validation of the prostate profile as a diagnostic screening test. PROPOSED COMMERCIAL APPLICATION: There will be 317,000 new cases of prostate carcinoma diagnosed in 1996. While serum PSA has improved screening, more sensitive and specific means are needed to screen and confirm cases of prostate cancer. It is recommended that all men over 50 be screened. A diagnostic urine test which a\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, genetic marker, neoplasm /cancer diagnosis, neoplasm /cancer genetics, prostate neoplasm, urinalysis RNA, biomarker, diagnostic test, gene expression, gonadotropin releasing factor, noninvasive diagnosis, prostate specific antigen, rapid diagnosis human subject, urineNational Cancer Institute (NCI)
