Medical Policy: 02.04.25
Original Effective Date: October 2009
Reviewed: December 2015
Revised: June 2016
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This Medical Policy document describes the status of medical technology at the time the document was developed. Since that time, new technology may have emerged or new medical literature may have been published. This Medical Policy will be reviewed regularly and be updated as scientific and medical literature becomes available.
Prostate cancer is the most commonly diagnosed cancer and the second leading cause of cancer deaths in American men. In 2016, it is estimated that 180,890 men will be diagnosed with prostate cancer and 26,120 will die of this disease. During the same period, nearly 20 million men in the United States will be confronted with important decisions regarding early detection for prostate cancer. Men in the United States have about one chance in 7 of eventually being diagnosed with this malignancy and about one chance in 30 of eventually dying of it.
The primary goal of prostate cancer screening is to reduce deaths due to prostate cancer, therefore, increasing length of life. An additional important outcome would be a reduction in the development of symptomatic metastatic disease. Screening asymptomatic geno typical men for prostate cancer has become a widespread practice in the United States. Test procedures used for prostate cancer screening include digital rectal examination (DRE) and serum prostate specific antigen (PSA).
Many experts continue to recommend DRE for screening, as some clinically significant cancers may potentially be missed using serum PSA cut-point alone. Studies have consistently shown that prostate cancer cases detected through PSA testing are more often confined to the prostate than those detected solely by DRE. Currently, 81% of prostate cancers are pathologically organ-confined at time of diagnosis.
The value of DRE as a stand-alone test for prostate detection is limited, even though DRE picks up some cases of advanced cancer that would otherwise be missed. DRE is recommended to be used as a complementary test with serum PSA in asymptomatic geno typical men who had a risk/benefit discussion and decided to pursue screening for prostate cancer. Those individuals with a very suspicious DRE should be considered for biopsy referral regardless of PSA results, because it may identify high-grade cancers in such situations. DRE should be considered in all geno typical men with an abnormal serum PSA to aid in decisions regarding biopsy.
Although PSA was originally introduced as a tumor marker to detect cancer recurrence or disease progression following treatment, it became widely adopted for cancer screening. PSA is a glycoprotein produced by the prostate epithelial cells. PSA levels may be elevated in geno typical men with prostate cancer because PSA production is increased and because tissue barriers between the prostate gland lumen and the capillary are disrupted, releasing more PSA into the serum. Elevations of serum PSA may also be associated with other prostatic diseases including benign prostatic hypertrophy (BPH) which is a major clinical problem with PSA screening. It is recommended that the interpretation of PSA values should always take into account age, the presence of urinary tract infection or prostate disease, recent diagnostic procedures and prostate directed treatments.
Prostate cancer screening has been a controversial issue. There is evidence that PSA based screening leads to substantial overdiagnosis of prostate tumors and there is a high incidence for physicians and patients to elect to treat most cases of screen detected cancer, given the current inability to distinguish tumors that will remain indolent from those destined to be lethal. Thus, many geno typical men are being subjected to the harms of treatment of prostate cancer that will never become symptomatic. Even for geno typical men whose screen-detected cancer would otherwise have been later identified without screening, most experience the same outcome and are, therefore, subjected to the harms of treatment for much longer period. There is convincing evidence that PSA based screening for prostate cancer results in considerable overtreatment and its associated harms.
Prostate cancer risk calculators have been developed to estimate an individual’s risk for prostate cancer from multiple factors. Common calculators are the Sunnybrook, ERSPC, and PCPT based risk calculators. These online tools combine clinical variables including but not limited to age, family history, race, DRE and PSA, to estimate both the risk for biopsy detectable prostate cancer and the risk for biopsy detectable high grade prostate cancer. Such information potentially allows for more informed decision-making. However, such calculators have not been assessed in RCTs, and cut-points of risk associated with reductions in prostate cancer mortality remain unknown. Such calculators have as much value in determining who might not need biopsy as in identifying those at higher risk. The use of risk calculators alone to determine whether a biopsy is indicated is not recommended.
Even though some guidelines (i.e. USPSTF) discourage the use of screening tests for which the benefits do not outweigh the harms in the target population, they do recognize the common use of PSA screening in practice today and that some physicians will continue to offer it. The decision to initiate or continue PSA screening should reflect an understanding of the possible benefits and harms and respect the patient’s preferences. Physicians should not offer or order PSA screening unless they are prepared to engage in shared decision making that enables an informed choice by the patient. Similarly, patients requesting PSA screening should be provided with the opportunity to make informed choices to be screened that reflect their values about specific benefits and harms.
Serum total PSA was the only PSA based test available in early detection programs for prostate cancer. Since then, several PSA derivatives have been developed and proposed to improve the performance of the PSA measurement, thus possibly increasing specificity and decreasing unnecessary biopsies. These PSA derivatives include:
At this time, evidence that prostate specific antigen (PSA) testing for prostate cancer screening reduces long-term mortality is lacking. It is recommended that healthcare professionals discuss the possible benefits, side effects, and questions about prostate specific antigen (PSA) testing for prostate cancer screening so that geno typical men can make informed decisions taking into account their own situation and risk. There is promising evidence from large-scale observational studies to conclude that PSA in conjunction with DRE can detect potentially curable prostate cancer. In addition, there is substantial evidence that the use of the PSA parameters, %fPSA (or %fPSA/tPSA) and cPSA, has the potential to decrease the number of unnecessary biopsies in geno typical men with tPSA between 4 and 10 ng/mL, enhancing the performance of the PSA test. However, as is the case with PSA testing, it has not yet been proven that %fPSA testing or cPSA testing can alter the long term clinical outcome of geno typical men with prostate cancer.
In 2012, The USPSTF published recommendations for prostate cancer screening that recommends against prostate specific antigen (PSA) based screening for prostate cancer. The USPSTF assigned a Grade D recommendation to this statement since there is moderate or high certainty that the service has no net benefit or that harms outweigh the benefits.
Although the USPSTF discourages the use of screening tests for which the benefits do not outweigh the harms in the target population, it recognizes the common use of PSA screening in practice today and understands that some men will continue to request screening and some physicians will continue to offer it. The decision to initiate or continue PSA screening should reflect an explicit understanding of the possible benefits and harms and respect the patients’ preferences. Physicians should not offer or order PSA screening unless they are prepared to engage in shared decision making that enables an informed choice by the patients. Similarly, patients requesting PSA screening should be provided with the opportunity to make informed choices to be screened that reflect their values about specific benefits and harms.
In 2013, the American Urological Association (AUA) published guidelines for the early detection of prostate cancer:
The Panel recommends against PSA screening men under age 40 years. (Recommendation; Evidence Strength Grade C). In this age group there is a low prevalence of clinically detectable prostate cancer, no evidence demonstrating benefit of screening and likely the same harms of screening as in other age groups.
The Panel does not recommend routine screening in me between ages 40 to 54 years at average risk. (Recommendation; Evidence Strength Grade C). For men younger than age 55 years at higher risk (e.g. positive family history or African American race), decisions regarding prostate cancer screening should be individualized.
For men ages 55 to 69 years the Panel recognizes that the decision to undergo PSA screening involves weighing the benefits of prostate cancer mortality in 1 man for every 1,000 men screened over a decade against the known potential harms associated with screening and treatment. For this reason, the Panel strongly recommends shared decision making for men age 55 to 69 years that are considering PSA screening, and proceeding based on a man’s values and preferences. (Standard; Evidence Strength Grade B). The greatest benefit of screening appears to be in men ages 55 to 69 years.
To reduce the harms of screening, a routine screening interval of two years or more may be preferred over annual screening in those men who have participated in shared decision making and decided on screening. As compared to annual screening, it is expected that screening intervals of two years preserve the majority of the benefits and reduce overdiagnosis and false positives. (Option; Evidence Strength Grade C). Additionally, intervals for rescreening can be individualized by a baseline PSA level.
The Panel does not recommend routine PSA screening in men age 70+ years or any man with less than a 10 to 15 year life expectancy. (Recommendation; Evidence Strength Grade C). Some men age 70+ years who are in excellent health may benefit from prostate cancer screening.
The panel concluded that PSA based screening should not be performed in the absence of shared decision making. Thus, they recommend against organized screening in settings where shared decision making is not part of routine practice (e.g., including but not limited to health fairs, health system promotions, community organizations).
Testing Frequency: There is evidence to suggest that annual screening is not likely to produce significant incremental benefits when compared with an inter-screening interval of two years. The PCLO trial compared annual screening with opportunistic screening in the US population, which corresponded to screening on average every two years. Prostate cancer mortality rates were similar in the two groups through 13 years of follow up.
Modeling studies have projected that screening intervals of two years will preserve most of the benefits of screening and reduce the harms (i.e. false positive tests and overdiagnosis) when compared with screening every year.
The Panel believes that annual PSA screening as a routine should be discouraged for those who choose to be screened, that two year PSA intervals are reasonable approach and will be unlikely to miss a curable prostate cancer in most men, and that for men over 60 with PSA levels below 1.0ng/ml, longer PSA screening intervals (e.g. of four years) could be considered.
Most Panel members favor informed testing beginning at age 45 years. Repeat testing at 1 to 2 year intervals is recommended for men who have a PSA value > 1.0 ng/mL and at 2 to 4 year intervals for men with PSA <1 ng/mL.
The panel recommends repeat teating every 2 to 4 years if PSA is <1 ng/mL and every 1 to 2 years if PSA 1 to 3 ng/mL in men aged 45 to 75 years. The panel notes that a younger man on the higher end of PSA (e.g. 45 year old man with PSA 0.9 ng/mL) might be screened in 2 years, whereas an older man with a lower PSA might be screened in 4 years. Clinical judgment should be used.
The Panel supports screening in men until age 75, and then continuing screening only in very select patients (category 2B). The panel notes that although some men in this older age group present with high-risk disease, very few men older than age 75 years benefit from PSA screening.
African-American men and men with a first degree relative with prostate cancer (especially cancer found at a younger age) have a higher risk of developing prostate cancer. In fact, having a first degree relative with prostate cancer diagnosed before theage of 60 increases the likelihood of prostate cancer diagnosis by 2.1 to 2.5 fold. Data, however, suggest that prostate cancer in men with a family history of prostate cancer is not more likely to be aggressive, and cancer specific outcomes are similar between those with and without a family history.
African-American men and men with a family history of prostate cancer represent high-risk groups. However, the panel believes that current data are insufficient to inform the best strategy for prostate cancer screening in these populations and also note that baseline PSA value is a stronger predictive factor that a positive family history or race. Therefore, although these individuals may require a higher level of vigilance and potentially different considerations when analyzing the results of screening tests, the panel does not give separate screening recommendations for these men at this time. Race is, however, included as a baseline evaluation factor for risk assessment that can be used to help decide when a man should begin the early detection process within the NCCN recommended ages of 45 to 75 years.
The American Cancer Society recommends that men make an informed decision with their health care provider about whether to be tested for prostate cancer. Research has not yet proven that the potential benefits of testing outweigh the harms of testing and treatment. We believe that men should not be tested without first learning about what we know and don’t know about the risks and possible benefits of testing and treatment.
(Last Medical Review: March 2015/Revised October 2015)
See Related Medical Policies
Prostate cancer screening using prostate specific antigen (PSA) may be considered medically necessary for any of the following indications after informed decision with a health care provider:
After the initial PSA is determined, the time interval for repeat testing is dependent upon the PSA value. For those men with a PSA of:
All other screening indications are considered not medically necessary.
The percent free PSA test (%fPSA), free-to-total PSA ratio (%fPSA/tPSA) and/or complexed PSA (cPSA) testing may be considered medically necessary for determining the need for prostate biopsy in a man with a normal or equivocal digital rectal examination (DRE) and an elevated tPSA of 4-10 ng/mL.
The percent free PSA (%fPSA, free-to-total PSA ratio (%fPSA/tPSA) or complexed PSA (cPSA) testing as screening tests for asymptomatic men for prostate cancer may be considered not medically necessary.
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