Epithelial quantitation of histologically normal prostate tissue predicts the presence of cancer in tissue biopsies

1. A method of treating prostate cancer in a human subject comprising the steps of:

(a) obtaining histologically normal prostate tissue from the subject;

(b) quantifying epithelial percentage greater than 39% in the histologically normal prostate tissue; and

(c) treating the human subject for prostate cancer.

2. The method of claim 1 , additionally comprising the steps of

(i) staining the tissue; and

(ii) imaging the tissue prior to the step of quantifying epithelial percentage in the stained, imaged tissue.

3. The method of claim 2 , wherein the tissue is stained with a stain specific for epithelial cells.

4. The method of claim 3 , wherein the stain is hematoxylin and eosin stain.

5. The method of claim 3 , wherein the stain is a high molecular weight cytokeratin stain.

6. The method of claim 2 , wherein the tissue is imaged using an automated imaging system.

7. The method of claim 6 , wherein the automated imaging system is selected from the group consisting of VECTRA™, Aperio eSlide Manager, TissueFAXS 220, TissueFAXS CONFOCAL PLUS 200.

8. The method of claim 2 , wherein the epithelial percentage is quantified using image analysis software.

9. The method of claim 8 , wherein the image analysis software is inform 2.1.1.

10. The method of claim 1 , wherein the epithelial percentage is greater than 40%.

11. The method of claim 2 , wherein the epithelial percentage is greater than 40%.

12. The method of claim 1 , wherein the epithelial percentage is between 39% and 80%.

13. The method of claim 2 , wherein the epithelial percentage is between 39% and 80%.