Test Code: 4006CPT: 84153
|Use||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.1 It is also the second leading cause of cancer deaths among American men.1 When employed for the management of prostate cancer patients, serial measurement of PSA is useful in detecting residual tumor and recurrent cancer after radical prostatectomy.2 Moreover, PSA may serve as an accurate marker for monitoring advancing clinical stage in untreated patients,3 as well as assessing response to therapy.4,5,6,7 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.|
|Clinical Utility||Elevated serum PSA concentration suggest the presence of prostate cancer, although a biopsy must be performed to verify. Serum PSA concentrations can also be elevated in benign prostatic hypertrophy, inflammatory conditions of the prostate and other adjacent tissues, on in men being treated for low T. PSA is generally not elevated in apparently healthy men or men with non-prostatic carcinoma.|
|Intended Patient Population||18+ and Older Adult Males|
|Patient Preparation||None Specified|
|Volume||4mL Whole Blood (1mL Serum)|
|Min Sample Volume||0.5 mLs|
|Reference Ranges||M ≥ 18 yrs old; ≤ 4.00 ng/mL|
|Analytical Measurement Range||0.01 - 150.00 ng/mL|
|Test Methodology||Chemiluminescent Immunoassay|
|Test Turnaround Time||7 Days|
|Limitations||The 5 alpha-reductase inhibitor drugs may affect PSA levels in some patients. Other drugs used to treat benign prostatic hyperplasia (BPH) may also affect PSA levels. Care should be taken in interpreting results from patients taking these drugs.|
|Specimen Stability||5 Days RT
6 Days RF
|Laboratory Developed Test (LDT)||Yes|
|CMS Guidance||NCD 190.31|
|References||1. Cancer Facts and Figures-1994. American Cancer Society, Inc., 1994, 1-28.
2. Stamey TA, Yang N, Hay AR, McNeal JE, Freiha FS, Redwine E. Prostate-specific antigen as a serum marker for adenocarcinoma of the prostate. New Engl J Med 1987;317: 909-916.
3. Stamey TA, Kabalin JN. Prostate specific antigen in the diagnosis and treatment of adenocarcinoma of I. Untreated patients. J Urol 1989;141: 1070-1075.
4. Killian CS, Yang N, Emrich LJ, Vargas FP, Kuriyama M, Wang MC, Slack NH, Papsidero LD, Murphy GP,Prognostic importance of prostate-specific antigen for monitoring patients with stages B2 to D1 prostate Cancer Res 1985;45: 886-891.
5. Stamey TA, Kabalin JN, McNeal JE, Johnstone IM, Freiha FS, Redwine E, Yang N. Prostate specific the diagnosis and treatment of adenocarcinoma of the prostate. II. Radical prostatectomy treated patients. 1989;141: 1076-1083.
6. Stamey TA, Kabalin JN, Ferrari M. Prostate specific antigen in the diagnosis and treatment of adenocarcinoma the prostate. III. Radiation treated patients. J Urol 1989;141: 1084-1087.
7. Stamey TA, Kabalin JN, Ferrari M, Yang N. Prostate specific antigen in the diagnosis and treatment adenocarcinoma of the prostate. IV. Anti-androgen treated patients. J Urol 1989;141: 1088-1090.