PREDICTIVE BIOMARKERS FOR PROSTATE CANCER
The invention relates to compositions and methods for detecting, screening, diagnosing or determining the progression of, regression of and/or survival from a proliferative disease or condition, specifically prostate cancer. The invention also provides new assays and kits for the staging or stratifying prostate cancer patients or patients suspected of having prostate cancer.
1 . A method for the binary stratification of a subject suspected of having prostate cancer comprising;
determining the level or grade of one or more predictor variables selected from the group consisting of FAS, NPY, USP2a, and AMACR in a samples obtained from the subject; and stratifying the subject as likely to survive at least 5 years or not based on the level or grade of said one or more predictor variables, wherein the grade of the predictor variable is less than 3.
2 . The method of claim 1 wherein the subject has previously been screened for elevated prostate specific antigen (PSA).
3 . The method of claim 2 wherein the predictor variable is USP2a.
4 . The method of claim 2 wherein the predictor variable is AMACR.
5 . The method of claim 1 wherein the grade of the predictor variable is less than 2.
6 . The method of claim 5 wherein the predictor variable is FAS.
7 . The method of claim 5 wherein the predictor variable is NPY.
8 . The method of claim 2 wherein the measurement of PSA is total PSA.
9 . The method of claim 2 , wherein the subject has undergone a tissue biopsy and wherein evaluation of the biopsy revealed a tissue Gleason score of between 5 and 7.
10 . The method of claim 1 wherein determining the level or grade of one or more predictor variables comprises measuring either the RNA or protein levels of said one or more predictor variables.
11 . The method of claim 10 wherein protein levels are measured.
12 . The method of claim 11 wherein protein levels are measured by an immunohistochemical assay.
13 . The method of claim 12 wherein the immunohistochemical assay utilizes one or more predictor variable specific antibodies.
14 . The method of claim 13 , wherein said one or more predictor variable specific antibodies contains a detectable label.
15 . An immunohistochemical kit or assay for the prediction of 5-year survival in a subject
comprising one or more predictor variable specific antibodies, each comprising a detectable label and selected from the group consisting of FAS, NPY, USP2a, and AMACR.
16 . The immunohistochemical kit or assay of claim 15 , further comprising a probe targeting the prostate specific antigen (PSA) gene or protein.