Thus, if the present study had been performed prospectively, 26% of subjects warranting prostate biopsy based on a PSA density ≥0.08 ng/mL/cc would have truly had clinically significant prostate cancer, while 96% of subjects who would have been excluded from prostate biopsy (PSA density <0.08 ng/mL/cc) would truly not have had clinically significant prostate cancer. The gene discussed is KLK3; the disease is prostate carcinoma.