Medical Policy: 02.04.25 

Original Effective Date: October 2009 

Reviewed: June 2020 

Revised: June 2018 

 

Notice:

This policy contains information which is clinical in nature. The policy is not medical advice. The information in this policy is used by Wellmark to make determinations whether medical treatment is covered under the terms of a Wellmark member's health benefit plan. Physicians and other health care providers are responsible for medical advice and treatment. If you have specific health care needs, you should consult an appropriate health care professional. If you would like to request an accessible version of this document, please contact customer service at 800-524-9242.

 

Benefit Application:

Benefit determinations are based on the applicable contract language in effect at the time the services were rendered. Exclusions, limitations or exceptions may apply. Benefits may vary based on contract, and individual member benefits must be verified. Wellmark determines medical necessity only if the benefit exists and no contract exclusions are applicable. This medical policy may not apply to FEP. Benefits are determined by the Federal Employee Program.

 

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.

 

Description:

Prostate cancer is the most commonly diagnosed cancer and the second leading cause of cancer deaths in American men. In 201, it is estimated that 14,60 men will be diagnosed with prostate cancer and 31,620 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 born in the United States have about 1 chance in 9 of eventually being diagnosed with this malignancy and about 1 chance in 41 of eventually dying of it. (NCCN 2.2019 Prostate Cancer Early Detection)

 

Older age, African American race, and family history of prostate cancer are the most important risk factors for the development of prostate cancer. In the United States, African American geno typical men are more likely to develop prostate cancer than white geno typical men (203.5 versus 121.9 cases per 100,000 men). African American geno typical men are also twice as likely as white geno typical men to die of prostate cancer (44.1 versus 19.1 deaths per 100,000 men).

 

Prostate cancer represents a spectrum of disease that ranges from non-aggressive, slow growing disease that may not require treatment to aggressive, fast growing disease that does.  The goal of screening for prostate cancer is to identify high-risk, localized prostate cancer that can be successfully treated, thereby preventing the morbidity associated with advanced or metastatic prostate cancer. Screening asymptomatic geno typical men for prostate cancer has become a widespread practice in the United States. Tests used for prostate cancer screening include digital rectal examination (DRE) and serum prostate specific antigen (PSA).

 

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 randomized controlled trials (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.

 

Best evidence supports the use of serum PSA for the early detection of prostate cancer. Still, many experts continue to recommend DRE for screening, as some clinically significant prostate cancer 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 enters the circulation through unknown mechanisms. 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 prostate procedures and prostate directed treatments.

 

PSA Derivatives

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:

  • Percent free PSA (%fPSA): Unbound or free PSA (fPSA), expressed as a ratio of tPSA, is a clinically useful molecular form of PSA, with the potential to improve early detection, staging and monitoring of prostate cancer. The FDA approved the use of %fPSA for the early detection of prostate cancer in men with a normal DRE and PSA levels between 4ng/mL and 10 ng/mL.
  • PSA Velocity (PSAV): The rate of change in PSA over time is broadly termed PSA velocity (PSAV), determined by at least 3 separate PSA values calculated over at least an 18 month period. PSAV ≥ 0.35 ng/mL/y is only one criterion to consider when deciding whether to perform biopsy for men with low PSA levels. Other factors such as age, comorbidity, race and family history also should be considered. Also, the predictive value of PSAV can be influenced by PSA levels, PSAV is not useful in patients with a very high > 10 ng/mL PSA values. An abnormal PSA result should be confirmed by retesting.
  • cPSA: PSA exists in free and several complexed forms. Direct measurement of the complexed form with alpha-1-antichymotrypsin is now available. For practical purposes, tPSA consists essentially of fPSA and the alpha-1-antichymotrypsin complex form (cPSA). The threshold levels are therefore not equivalent: cPSA levels of 2.2 ng/mL and 3.4 ng/mL are equivalent to tPSA levels of 2.5 ng/mL and 4.0 ng/mL, respectively. The ratio of cPSA to tPSA should provide information comparable to the fPSA to tPSA ratio. The use of cPSA has been approved as an aid in the detection of prostate cancer in men aged 50 years or older in conjunction with DRE. However, because cPSA has not gained widespread acceptance in a day-to-day clinical practice, it has not been incorporated into early detection guidelines as a baseline measure.
  • PSA Density (PSAD): PSAD requires measurement of prostate volume by TRUS and is expressed as the PSA value (in nanograms per milliliter; ng/mL) divided by the prostate volume (in cc, cubic centimeters). PSAD is a means of discriminating prostate cancer from BPH: the lower the PSAD, the greater the probability of BPH. Thus PSAD potentially identifies men who do not have prostate cancer but have high PSA secondary to large volume prostates. The lack of precision of measurement of both PSA and prostate volume has prevented the widespread clinical use of PSAD. PSAD has not been incorporated into early detection guidelines as a baseline measure because PSAD alone may offer little added benefit over other tests and requires ultrasound.

 

Even though some guidelines (i.e. USPSTF) may not recommend the routine use of screening tests for prostate cancer 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.

 

Prostate cancer screening has been a controversial issue. There is evidence that PSA based screening leads to substantial over-diagnosis 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.

 

Despite its limitations, recent population-based prostate cancer screening studies have demonstrated survival benefits using PSA, sometimes in combination with digital rectal examination (DRE).

 

PSA-based screening for prostate cancer has been studied in 3 very large RCTs, each with at least a decade of median follow-up: the US-based Prostate, Lung, Colorectal, and Ovarian (PLCO) Cancer Screening Trial, the European Randomized Study of Screening for Prostate Cancer (ERSPC), and the Cluster Randomized Trial of PSA Testing for Prostate Cancer (CAP). These trials used varying screening intervals (from 1-time screening to every 1 to 4 years) and PSA thresholds (2.5 to 10.0 ng/mL) for diagnostic biopsy.

 

In 2018, de Koning et. al. reported on the efficacy of prostate-specific antigen screening and the impact of the key components in the European Randomized Study for Prostate Cancer (ERSPC) and the U.S. Prostate, Lung, Colorectal and Ovarian (PLCO) trials. The European Randomized Study of Screening for Prostate Cancer (ERSPC) demonstrated that prostate-specific antigen (PSA) screening significantly reduced prostate cancer mortality (rate ratio, 0.79; 95% confidence interval, 0.69-0.91). The U.S. Prostate, Lung, Colorectal, and Ovarian (PLCO) trial indicated no such reduction but had a wide 95% CI (rate ratio for prostate cancer mortality, 1.09; 95% CI, 0.87-1.36). Standard meta-analyses are unable to account for key differences between the trials that can impact the estimated effects of screening and the trials' point estimates. The authors calibrated 2 microsimulation models to individual-level incidence and mortality data from 238,936 men participating in the ERSPC and PLCO trials. A cure parameter for the underlying efficacy of screening was estimated by the models separately for each trial. The authors changed step-by-step major known differences in trial settings, including enrollment and attendance patterns, screening intervals, PSA thresholds, biopsy receipt, control arm contamination, and primary treatment, to reflect a more ideal protocol situation and differences between the trials. Using the cure parameter estimated for the ERSPC, the models projected 19% to 21% and 6% to 8%, respectively, prostate cancer mortality reductions in the ERSPC and PLCO settings. Using this cure parameter, the models projected a reduction of 37% to 43% under annual screening with 100% attendance and biopsy compliance and no contamination. The cure parameter estimated for the PLCO trial was 0. The authors concluded, the observed cancer mortality reduction in screening trials appears to be highly sensitive to trial protocol and practice settings. Accounting for these differences, the efficacy of PSA screening in the PLCO setting is not necessarily inconsistent with ERSPC results.

 

The potential benefit of screening for prostate cancer is because of treatment. It is important for geno typical men to consider both the potential benefits and harms of treatment (including surveillance) as they consider whether to be screened. Geno typical men not able or willing to tolerate treatment should not be screened for prostate cancer. Most cases of prostate cancer advance very slowly, if at all, the 10 year survival rate for screen-detected, localized prostate cancer is very high. In recent major trial that enrolled more than 1500 men randomized to receive either active treatment or active surveillance, the 10-year survival rate in all groups was 99%. The good prognosis for early stage prostate cancer makes it difficult to study the effectiveness of treatment.

 

Multiple treatment options exist for prostate cancer, the three most common treatment options for men with screen-detected localized prostate cancer are surgical removal of prostate gland (radical prostatectomy), radiation therapy, and active surveillance. Available evidence on treatment evaluating the effectiveness of screening found that current evidence suggests that treatment of early-stage, screen-detected prostate cancer with radical prostatectomy or radiation therapy likely reduces the risk of clinical progression and metastatic disease and may reduce prostate cancer mortality.

 

Active surveillance is a treatment approach that seeks to limit the harms of treatment by allowing men with apparent low-risk prostate cancer to forego surgery or radiation in favor of ongoing monitoring of their cancer. Although protocols vary, active surveillance usually includes regular, repeated PSA testing and often repeated digital rectal examination (DRE) and prostate biopsy, with the potential for exposure to repeated harms from biopsies. Geno typical men whose cancer is found to be changing are offered definitive treatment with surgery or radiation therapy. Active surveillance has become a more common treatment choice in the United States over the past several years. Active treatment of prostate cancer can result in major adverse effects.

 

Summary

There have been a number of clinical studies identified in the peer-reviewed medical literature that address the impact of PSA screening on the stage of cancer detection and on disease-specific survival rates, as well as studies that evaluate the relative sensitivities and specificities of derivative types of PSA testing. Although PSA testing is widely used there is controversy regarding the question of whether PSA-based screening reduces prostate cancer mortality. In addition, PSA-based screening is associated with risks of overdiagnosis and overtreatment. The 2019 National Comprehensive Cancer Network Guideline (NCCN) on Prostate Cancer Early Detection states in the NCCN recommendations that factors to consider in the early detection of prostate cancer include the patient’s age, life expectancy, race, presence of inherited mutations, family history, and previous results from early detection tests. The NCCN Panel recommends that baseline testing should be offered to healthy, well-informed men aged 45 to 75 years based on the results of randomized controlled trials (RCTs). Baseline testing may be complemented by DRE. The panel recommends frequency of repeat testing be 2 to 4 years for men aged 45 to 75 years with serum PSA values below 1 ng/mL. For men with PSA of 1 to 3 ng/mL, repeat testing should occur at 1 to 2 year intervals. The panel recommends that PSA testing be considered only in very select patients after the age of 75 years (category 2B [Based on lower-level evidence, there is NCCN consensus that the intervention is appropriate]) and that indication for biopsy be carefully evaluated. The NCCN recommendation also states African American men have a higher incidence of prostate cancer, increased prostate cancer mortality, and earlier age of diagnosis compared to Caucasian-American men. This is attributable to a greater risk of developing preclinical prostate cancer and a higher likelihood that a preclinical tumor will spread. Consequently, it is reasonable for African American men to consider shared decision making about PSA screening at age 40 and to consider screening at annual intervals rather than every other year. Panel members uniformly discourage PSA testing in men unlikely to benefit from prostate cancer diagnosis based on age and/or comorbidity.  The primary goal of PSA based screening is to find men from whom treatment would reduce morbidity and mortality.

 

Practice Guidelines and Position Statements

American Urological Association (AUA)

In 2013, the American Urological Association (AUA) published guidelines for the early detection of prostate cancer, this guideline was reviewed and validity confirmed 2018:

 

Guideline Statements
  • 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. Those at higher risk may include men of African American race; and those with a family history of metastatic or lethal adenocarcinomas (e.g. prostate, male and female breast cancer, ovarian, pancreatic) spanning multiple generations, affecting multiple first-degree relatives, and that developed at younger ages.
  • For men ages 55 to 69 years the Panel recognizes that the decision to undergo PSA screening involves weighing the benefits of reducing the rate of metastatic prostate cancer and prevention of prostate cancer death 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 over age 70 years or any man with less than a 10 to 15 year life expectancy. (Recommendation; Evidence Strength Grade C).
    • Some men over 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:

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. Men with PSA below 3 ng/mL at age 70 to 75 years, PSA screening could be safely discontinued if a man at this age is still being screened.

 

The American Cancer Society (ACS)

In 2019, the American Cancer Society reaffirmed their recommendations that men make an informed decision with their health care provider about whether to be screened for prostate cancer. The decision should be made after getting information about the uncertainties, risk, and potential benefits of prostate cancer screening. Men should not be screened unless they have received this information. The discussion about screening should take place at:

  • Age 50 for men who are at average risk of prostate cancer and are expected to live at least 10 more years.
  • Age 45 for men at high risk of developing prostate cancer. This includes African Americans and men who have a first degree relative (father, brother, or son) diagnosed with prostate cancer at an early age (younger than age 65)
  • Age 40 for men at even higher risk (those with more than one first degree relative who had prostate cancer at an early age)

 

After this discussion men who want to be screened should be tested with the prostate specific antigen (PSA) blood test. The digital rectal exam (DRE) may also be done as part of screening.

 

If, after this discussion, a man is unable to decide if testing is right for him, the screening decision can be made by the health care provider, who should take into account the man’s general health preferences and values.

 

If no prostate cancer is found as a result of screening, the time between future screenings depends on the results of the PSA blood test:

  • Men who choose to be tested who have a PSA of less than 2.5 ng/mL may only need to be retested every 2 years.
  • Screening should be done yearly for men whose PSA level is 2.5 ng/mL or higher.

 

Because prostate cancer often grows slowly, men without symptoms of prostate cancer who do not have a 10-year life expectancy should not be offered testing since they are not likely to benefit. Overall health status, and not age alone, is important when making decisions about screening.

 

Even after a decision about testing has been made, the discussion about the pros and cons of testing should be repeated as new information about the benefits and risks of testing becomes available. Further discussions are also needed to take into account changes in a man’s health, values, and preferences.

 

National Comprehensive Cancer Network (NCCN)

Prostate Cancer Early Detection Version 2.2019

The guidelines for when to start and stop screening, at what intervals to conduct a screening, and when to biopsy were recommended by most panel members, but a consensus was not reached. The guidelines are continuously in a state of evolution, and the panel will incorporate changes based on new evidence and expert opinion and provide a rating of consensus for each recommendation.

 

Baseline Evaluation

History and physical including:

  • Family history
  • Medications
  • History of prostate disease and screening including prior PSA and/or isoforms, exams and biopsies
  • Race
  • Family history of high risk germline mutations

 

Start risk and benefit discussion about offering prostate screening:
  • Baseline PSA
  • Strongly consider baseline digital rectal examination (DRE)

 

Early Detection Evaluation
Age 45-75 years
  • PSA < 1 ng/mL, DRE normal if done: repeat testing at 2-4 year intervals
  • PSA1-3 ng/mL, DRE normal if done: repeat testing at 1-2 year intervals
  • PSA > 3 ng/mL and/or very suspicious DRE: see indications for biopsy

 

African American men have a higher incidence of prostate cancer, increased prostate cancer mortality, and earlier age of diagnoses compared to Caucasian-American men. This is attributable to a greater risk of developing preclinical prostate cancer and a higher likelihood that a preclinical tumor will spread. Consequently, it is reasonable for African-American mend to consider beginning shared decision making about PSA screening at age 40 and to consider screening at annual intervals rather than every other year.

 

Age > 75 years in select patients (category 2B)
  • PSA < 4 ng/mL, DRE normal (if done) and no other indications for biopsy: repeat testing in select patients at 1-4 year intervals
  • PSA ≥ 4 ng/mL or very suspicious DRE: see indications for biopsy
  • Not screened: testing after 75 years of age should be done only in very healthy men with little or no comorbidity (especially if they have never undergone PSA testing) to detect the small number of aggressive cancers that post a significant risk if left undetected until signs or symptoms develop. Widespread screening in this population would substantially increase rates of over-detection and is not recommended.

 

U.S. Preventative Services Task Force (USPSTF)

In 2018, The USPSTF published updated recommendations regarding prostate cancer screening that states the following:

 

Men ages 55–69

For men aged 55 to 69 years, the decision to undergo periodic prostate-specific antigen (PSA)–based screening for prostate cancer should be an individual one. Before deciding whether to be screened, men should have an opportunity to discuss the potential benefits and harms of screening with their clinician and to incorporate their values and preferences in the decision. Screening offers a small potential benefit of reducing the chance of death from prostate cancer in some men. However, many men will experience potential harms of screening, including false-positive results that require additional testing and possible prostate biopsy; overdiagnosis and overtreatment; and treatment complications, such as incontinence and erectile dysfunction. In determining whether this service is appropriate in individual cases, patients and clinicians should consider the balance of benefits and harms on the basis of family history, race/ethnicity, comorbid medical conditions, patient values about the benefits and harms of screening and treatment-specific outcomes, and other health needs. Clinicians should not screen men who do not express a preference for screening.

 

Grade C Recommendation

 

Men age 70 and older

The USPSTF recommends against PSA-based screening for prostate cancer in men age 70 years and older.

 

Grade D Recommendation

 

This recommendation applies to adult men in the general U.S. population without symptoms or a previous diagnosis of prostate cancer. It also applies to men at increased risk of death from prostate cancer because of race/ethnicity or family history of prostate cancer.

 

Prior Approval:

Not applicable

 

Policy:

See Related Medical Policies

  • 02.04.56 Genetic and Protein Biomarkers for the Diagnosis and Cancer Risk Assessment of Prostate Cancer
  • 02.04.57 Gene Expression Profiling and Protein Biomarkers for Prostate Cancer Management

 

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:

  • Asymptomatic men 40-49 years of age who are at high risk of prostate cancer due to any of the following factors:
    • African-American race; or
    • More than one first degree relative (father, brother, or son) diagnosed with prostate cancer at an early age (younger than age 65); or
  • Asymptomatic men age 50 and over with a life expectancy of at least 10 years.

 

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:

  • PSA < 1 ng/ml repeat testing may be performed at 2 - 4 year intervals
  • PSA 1-3 ng/ml repeat testing may be performed at 1-2 year intervals

 

All other screening indications in asymptomatic men are considered not medically necessary.

 

Procedure Codes and Billing Guidelines:

To report provider services, use appropriate CPT* codes, Modifiers, Alpha Numeric (HCPCS level 2) codes, Revenue codes, and/or diagnosis codes.

  • 84152 Prostate-specific antigen (PSA); complexed (direct measurement)
  • 84153 Prostate specific antigen (PSA); total
  • 84154 Prostate-specific antigen (PSA); free
  • G0103 Prostate cancer screening, prostate specific antigen test (PSA)

 

Selected References:

  • Barry MJ. Clinical Practice. Prostate-specific-antigen testing for early diagnosis of prostate cancer. N Engl J Med. 2001 May 3; 344(18):1373-7.
  • Wilson WG et al. Abelhoff’s Clinical Oncology, 4th ed. Churchill Livingstone Elsevier, Philadelphia, PA, 2008, Chap. 88, “Prostate Cancer”.
  • Andriole GL, Crawford ED, Grubb 3rd RL et al. Mortality Results from a Randomized Prostate-Cancer Screening Trial. N Engl J Med 2009; 360(13): 1310-19.
  • Brawley OW, Ankerst DP, Thompson IM. Screening for Prostate Cancer. CA Cancer J Clin 2009[Epub prior to print June 29, 2009].
  • Schroder FH, Hugosson J, Roobol MJ et al. Screening and Prostate Cancer Mortality in a Randomized European Study. N Engl J Med 2009; 360(13): 1320-28.
  • Miller MC, O’Dowd GJ, Partin AW et al. Contemporary use of complexed PSA and calculated percent free PSA for early detection of prostate cancer: Impact of changing disease demographics. Urology. 2001 Jun;57(6):1105-11.
  • Catalona WJ, Partin AW, Slawin KM et al. Use of the percentage of free prostate-specific antigen to enhance differentiation of prostate cancer from benign prostatic disease: A prospective multicenter clinical trial. JAMA. 1998 May 20; 279(19):1542-7.
  • Lin K, Lipsitz R, Miller T et al. Benefits and Harms of Prostate-specific Antigen Screening for Prostate Cancer: An Evidence Update for the U.S. Preventive Services Task Force. Ann Intern Med. 2008;149(3):192-99.
  • Lim LS, Sherin K, and the American College of Preventive Medicine (ACPM) Prevention Practice Committee. Screening for Prostate Cancer in U.S. Men: ACPM Position Statement on Preventive Practice. Am J Prev Med 2008;34(2):164-70.
  • Wolf AM, Wender RC, Etzioni RB et al. American Cancer Society Prostate Cancer Advisory Committee. American Cancer Society guideline for the early detection of prostate cancer: update 2010. CA Cancer J Clin 2010 Mar-Apr;60(2):70-98
  • Sandblom G, Varenhorst E, Rosell J et al. Randomised prostate cancer screening trial: 20 year follow up. BMJ 2011;342:d1539. doi:10.1136/bmj.d1539.
  • Shao Y-H, Albertsen PC, Roberts CB et al. Risk profiles and treatment patterns among men diagnosed as having prostate cancer and a prostate-specific antigen level below 4.0 ng/mL. Arch Intern Med. 2010;170(14):1256-61.
  • Djulbegovic M, Beyth RJ, Neuberger MM et al. Screening for prostate cancer: systematic review and meta-analysis of randomised controlled trials. BMJ 2010;341:c4543. doi:10.1136/bmj.c4543.
  • Crawford ED, Grubb III R, Black A et al. Comorbidity and mortality results from a randomized prostate cancer screening trial. J Clin Oncol Feb 1,2011;29(4):355-61.
  • Loeb S, Vonesh EF, Metter J et al. What is the true number needed to screen and treat to save a life with prostate-specific antigen testing? J Clin Oncol Feb1, 2011;29(4):464-67.
  • Hugosson J, Carlsson S, Aus G et al. Morality results from the Göteborg randomised population-based prostate-cancer screening trial. Lancet Oncol 11:725-32, 2010.
  • Chou R, Croswell JM, Dana T et al. Screening for prostate cancer: a review of the evidence for the US Preventive Services Task Force. Ann Intern Med. 2011; 155(11):762-71.
  • Cooperberg MR, Broering JM, Carroll PR. Time trends and local variations in primary treatment of localized prostate cancer. J Clin Oncol. 2010; 28(7):1117-1123.
  • US Preventive Services Task Force (USPSTF) Screening for Prostate Cancer; final recommendation statement, 2018
  • American Society of Clinical Oncology. Screening for Prostate Cancer with Prostate Specific Antigen Testing: American Society of Clinical Oncology Provisional Clinical Opinion. Journal of Clinical Oncology. DOI:10.1200/JCO.2012.43.3441.
  • UpToDate . Screening for Prostate Cancer. Richard M. Hoffman, M.D.,MPH. Topic Last Updated January 15, 2018.
  • National Institute for Health and Clinical Excellence (NICE), NICE Issues Draft Diagnostics Guidance on Prostate Cancer Tests, Press Release, December 17, 2014.
  • American Cancer Society Guidelines Recommendations for Prostate Cancer Early Detection. Last medical review 8/1/2019. Last Revised 8/14/2019.
  • National Comprehensive Cancer Network (NCCN) Prostate Cancer Early Detection Version 2.2019
  • American Academy of Family Physicians (AAFP). Clinical Recommendations. Prostate Cancer. 2012.
  • Andriole GL, Crawford ED, Grubb RL 3rd, Buys SS, Chia D, Church TR, et al; PLCO Project Team. Prostate cancer screening in the randomized Prostate, Lung, Colorectal, and Ovarian Cancer Screening Trial: mortality results after 13 years of follow-up. J Natl Cancer Inst. 2012 Jan 18;104(2):125-32. PMID 22228146
  • Canadian Agency for Drugs and Technologies in Health (CADTH). Prostate Cancer Screening: A Review of the Guidelines. Nov 29, 2013.
  • Crawford ED, Grubb R 3rd, Black A, Andriole GL Jr, Chen MH, Izmirlian G, et al. Comorbidity and mortality results from a randomized prostate cancer screening trial. J Clin Oncol. 2011 Feb 1;29(4):355-61.
  • Ilic D, Neuberger MM, Djulbegovic M, Dahm P. Screening for prostate cancer. Cochrane Database Syst Rev. 2013 Jan 31;1:CD004720.
  • Hayes J, Barry M. Screening for prostate cancer with prostate specific antigen test a review of current evidence, JAMA 2014:311(11):1143-1149
  • American Cancer Society Cancer Facts and Figures 2017.
  • Lin K, Croswell J, Koenig H, et. al. Prostate Specific Antigen Based Screening for Prostate Cancer. An Evidence Updated for the U.S. Preventative Services Task Force, Evidence Synthesis No. 920. Agency for Healthcare Research and Quality (AHRQ) 2011 Oct. Report No: 12-5160-EF-1
  • UpToDate. Measurement of Prostate Specific Antigen. Stephen Freedland M.D., Topic last updated April 18, 2017. 
  • de Koning HJ, Gulati R, Moss SM. et. al. The efficacy of prostate-specific antigen screening: impact of key components in the ERSPC and PLCO trials. Cancer 2018 Mar 15:125(6):1197-1206
  • Basch E, Oliver T, Vickers A, et. al. Screening for Prostate Cancer with Prostate Specific Antigen Testing: American Society of Clinical Oncology Provisional Clinical Opinion. Journal of Clinical Oncology Volume 30 Number 24 August 20, 2012 
  • Ballentine HB, Albertsen P, Barry MJ. et. al. Early Detection of Prostate Cancer: AUA Guideline. This guideline was approved by the AUA Board of Directors April 2013, this guideline was reviewed and confirmed current as of June 2018.    

 

Policy History:

  • June 2020 - Annual Review, Policy Renewed
  • June 2019 - Annual Review, Policy Renewed
  • June 2018 - Annual Review, Policy Revised
  • June 2017 - Annual Review, Policy Revised
  • June 2016 - Annual Review, Policy Revised
  • December 2015 - Annual Review, Policy Revised
  • February 2015 - Annual Review, Policy Revised
  • March 2014 - Annual Review, Policy Revised
  • April 2013 - Annual Review, Policy Revised
  • February 2013 - Interim Review, Policy Revised
  • April 2012 - Annual Review, Policy Renewed
  • May 2011 - Annual Review, Policy Renewed

 

Wellmark medical policies address the complex issue of technology assessment of new and emerging treatments, devices, drugs, etc.   They are developed to assist in administering plan benefits and constitute neither offers of coverage nor medical advice. Wellmark medical policies contain only a partial, general description of plan or program benefits and do not constitute a contract. Wellmark does not provide health care services and, therefore, cannot guarantee any results or outcomes. Participating providers are independent contractors in private practice and are neither employees nor agents of Wellmark or its affiliates. Treating providers are solely responsible for medical advice and treatment of members. Our medical policies may be updated and therefore are subject to change without notice.

 

*CPT® is a registered trademark of the American Medical Association.