DESCRIPTION
Prostate cancer is a complex, heterogeneous disease. At the extremes of the spectrum, if left untreated, some prostate cancers behave aggressively, metastasize quickly, and cause mortality, while others are indolent and never progress to cause harm. Current challenges in prostate cancer care are risk assessment; early and accurate detection; monitoring low-risk patients undergoing surveillance only; prediction of recurrence after initial treatment; detection of recurrence after treatment; and assessing efficacy of treatment for advanced disease.
In response to the need for better biomarkers for risk assessment, diagnosis, and prognosis, a variety of exploratory research is ongoing. Some products of this work have already been translated or are in the process of being translated into commercially available tests, including:
Single-nucleotide polymorphisms (SNPs) for risk assessment
PCA3 for disease diagnosis and prognosis
TMPRSS fusion genes for diagnosis and prognosis
Multiple gene tests (gene panels) for prostate cancer diagnosis
Gene hypermethylation for diagnosis and prognosis
While studies using these tests generate much information that may help elucidate the biologic mechanisms of prostate cancer and eventually help design treatments, the above-mentioned tests are in a developmental phase.
SNP testing as part of genome-scanning tests with risk assessments for prostate cancer are offered by a variety of laboratories including Navigenics, LabCorp (23andme), and ARUP (deCode) as laboratory-developed tests. The PCA3 test is offered in the U.S. by a number of reference laboratories including ARUP, Mayo Medical Laboratories, and LabCorp. The reagents used in testing are developed by Gen-Probe. The Prostate Gene Expression Profile was widely announced as available from Clarient, Inc. in January 2009; as of March 2011, the test no longer appears on the listing at the company website. A test for hypermethylation of GSTP1 is currently available from LabCorp (“Glutathione S-transferase Gene [GSTP1, pi-class] Methylation Assay”), and the required specimen is formalin-fixed, paraffin-embedded tissue. The test is stated to be an adjunct to histopathology. Epigenomics AG (Frankfurt, Germany) has entered licensing agreements with two U.S. laboratories (Quest and Predictive Biosciences) to establish and commercialize laboratory-developed tests for its proprietary methylation biomarker GSTP1. This test is not yet available, and it is unclear what matrices will be used.
POLICY
Genetic tests for the screening, detection, and management of prostate cancer, including, but not limited to the following, are considered investigational:
Single-nucleotide polymorphisms (SNPs) for risk assessment
PCA3 for disease diagnosis and prognosis
TMPRSS fusion genes for diagnosis and prognosis
Multiple gene tests (gene panels) for prostate cancer diagnosis
Gene hypermethylation for diagnosis and prognosis.
See also: Prostate Specific Antigen (PSA)
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ADDITIONAL INFORMATION
The evidence for genetic tests related to prostate cancer screening, detection, and management variably but incompletely addresses clinical validity, i.e., the association of the test result with outcomes of interest expressed in terms of clinical performance characteristics such as sensitivity, specificity, predictive value, and comparisons to current standards using receiver-operating curve analysis and/or logistic regression. These data do not demonstrate clinical utility, i.e., that using a test will change treatment decisions and improve subsequent outcomes that matter to the patient such as mortality, morbidity, or quality of life. Thus, use of this testing for risk assessment, diagnosis, prognosis, and management of prostate cancer is considered investigational.
SOURCES
BlueCross BlueShield Association. Medical Policy Reference Manual. (4:2011). Gene-based tests for screening, detection, and/or management of prostate cancer (2.04.33). Retrieved June 15, 2011 from BlueWeb. (44 articles and/or guidelines reviewed)
Stangelberger, A., Margreiter, M., Seitz, C., & Djavan, B. (2007). Prostate cancer screening markers. The Journal of Men’s Health & Gender, 4 (3), 233-244.
Stephan, C., Rittenhouse, H., Cammann,H., Lein, M., Schrader, M., Deger, S., et al. (2009). New markers and multivariate models for prostate cancer detection. Anticancer Research, 29 (7), 2589-2600. (Level 1 Evidence)
Technology Evaluation Center. (2009). Special report: recent developments in prostate cancer genetics and genetic testing. (Vol. 23, No. 7). Retrieved October 13, 2009 from http://www.bcbs.com/blueresources/tec/vols/23/23_07.pdf. (108 articles and/or guidelines reviewed)
ORIGINAL EFFECTIVE DATE: 11/1/2004
MOST RECENT REVIEW DATE: 6/16/2011
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