The answer to both questions is no. Whether 10 or 499 or 1000 out of 2162 subjects have clinically significant prostate cancer, we should expect no difference in the percentage of diseased subjects who are correctly identified by the PSA density test as diseased (i.e., true positives), nor any difference in the percentage of non-diseased subjects correctly identified by the PSA density test as non-diseased (i.e., true negatives). This evidence concerns the gene KLK3 and Familial prostate cancer.