Clinical Significance

Prostate Cancer is the most common type of cancer found in men in the United States, with an incidence of approximately one case for every ten men. It is also the second leading cause of cancer deaths among American men. A reliable test for detecting early stage prostate cancer, when the tumor is confined to the gland and effective treatment can be provided, can be of great value to the physician. Historically, a majority of prostate cancers had advanced beyond the gland at the time of diagnosis. The digital rectal examination (DRE) is a commonly used technique for prostate cancer detection; nevertheless DRE, as it is generally performed in medical, practice, misses a significant number of cancers, including many organ-confined tumors.

Other clinical applications have been clearly demonstrated for PSA. When employed for the management of prostate cancer patients, serial measurements of PSA is useful in detecting residual tumor and recurrent cancer after radical prostatectomy. Moreover, PSA may serve as an accurate marker for monitoring advancing clinical stage in untreated patients, as well as assessing response to therapy. Therefore, serial measurement of PSA concentrations can be an important tool in monitoring patients with prostate cancer and in determining the potential and actual effectiveness of surgery or other therapies. Other biochemical markers such as prostatic acid phosphatase (PAP) and carcinoembryonic antigen (CEA) lack sufficient specificity for monitoring disease, and are unsuited for detecting early stage prostate cancer.

Elevated serum PSA concentrations can only suggest the presence of prostate cancer until a biopsy is performed. Serum PSA concentrations can also be elevated in benign prostatic hypertrophy or inflammatory conditions of the prostate and other adjacent tissues. PSA is generally not elevated in apparently healthy men or men with non-prostatic carcinoma. Physicians should discuss the risks and benefits of PSA testing with their patients.

_{Source: Beckman Coulter Access Hybritech PSA IFU. REF #A59415}