What are the inclusion criteria for using the Prostate-Specific Antigen (PSA) test for prostate cancer detection?

PSA Screening Should Be Used Through Shared Decision-Making in Age-Appropriate Men, Not Based on Symptoms or Maximizing Detection

PSA screening is most appropriately used through informed, shared decision-making with men aged 55-69 years (or 45-50 years for high-risk populations including African Americans and those with family history), rather than symptom-based testing or attempting to maximize detection rates. The correct answer is closest to option A, though with important nuances about age ranges and the critical requirement for informed consent regarding uncertain benefits and definite harms. 1

Why Not Symptom-Based Screening (Option B is Wrong)

• PSA is a screening test for asymptomatic men, not a diagnostic test for symptomatic disease. 1
• The presence of urinary symptoms was not an inclusion or exclusion criterion in major screening trials, and approximately one quarter of men in screening trials had bothersome lower urinary tract symptoms. 1
• Men with urinary symptoms actually have a lower risk for prostate cancer among those with elevated PSA levels compared to asymptomatic men. 1
• Using PSA only in symptomatic patients defeats the purpose of early detection and would miss the window for potentially beneficial intervention. 1

Why Not Maximizing Detection (Option C is Wrong)

• The fundamental problem with PSA screening is overdetection and overtreatment, not underdetection. 1
• Both major trials (ERSPC and PLCO) demonstrate that prostate cancer screening leads to substantial overdetection and overtreatment of indolent cancers. 1
• Maximizing detection would dramatically worsen the harm-to-benefit ratio by identifying even more clinically insignificant cancers that would never affect mortality or quality of life. 1
• As many as 33% of elderly US men with competing medical comorbidities at high risk of dying from other causes underwent screening—this represents harmful overdetection. 1

The Evidence-Based Inclusion Criteria for PSA Screening

Age-Based Recommendations with Shared Decision-Making

Primary screening population (strongest consensus): 1

• Men aged 55-69 years should be provided information about potential benefits and harms to enable informed decision-making (US Preventive Services Task Force 2018). 1
• Men aged 50-70 years are the target population per NCCN guidelines. 1

High-risk populations (earlier initiation): 1

• African American men should begin discussions at age 45 years. 1
• Men with a first-degree relative diagnosed with prostate cancer before age 65 should begin discussions at age 45 years. 1
• Men with multiple first-degree relatives diagnosed before age 65 should begin discussions at age 40 years. 1
• The American Urological Association recommends obtaining a baseline PSA at age 40 years for risk stratification. 1

Upper age limits: 1

• Recommend against routine screening in men aged ≥70 years (US Preventive Services Task Force). 1
• Testing above age 75 should be done with extreme caution and only in very healthy men with little or no comorbidity, as screening in this population substantially increases overdetection rates. 1
• Very few men above age 75 benefit from PSA testing. 1

Life Expectancy Requirements

• Men must have a life expectancy of at least 10-15 years to potentially benefit from screening. 1
• The European Association of Urology recommends screening only for well-informed men with good performance status and life expectancy ≥10-15 years. 1
• This requirement exists because prostate cancer typically progresses slowly, and men with shorter life expectancies are more likely to die from competing causes. 1

The Critical Requirement: Informed Consent and Shared Decision-Making

This is the most important inclusion criterion that distinguishes appropriate from inappropriate PSA use: 1

• Two-thirds of US men reported no past discussion with physicians about advantages, disadvantages, or scientific uncertainty regarding PSA screening—this represents inappropriate use. 1
• Men should understand that the benefits are uncertain and modest, while harms from surgery or radiation therapy are definite. 1
• The informed decision-making process should include: 1
  • Understanding basic aspects of prostate cancer and the role of screening
  • Understanding uncertainties, risks, and potential benefits
  • Considering personal preferences and values
  • Making a values-based decision

Screening Intervals for Those Who Choose Screening

For men who opt for screening after informed consent: 1

• PSA <1 ng/mL: Repeat testing at 2-4 year intervals. 1, 2
• PSA 1-2.5 ng/mL: Repeat testing every 2 years. 1
• PSA ≥2.5 ng/mL: Annual screening. 1
• Men at age 60 with PSA <1.0 ng/mL have very low risk of metastases or death from prostate cancer. 1

Common Pitfalls to Avoid

Screening without counseling: 1

• The European Association of Urology explicitly recommends against PSA testing without prior counseling on potential risks and benefits. 1
• Community-based screening programs must ensure high-quality informed decision-making and appropriate follow-up care. 1

Screening men with limited life expectancy: 1

• This substantially increases overdetection without providing mortality benefit. 1
• Consider increasing the PSA threshold for biopsy in men >70 years (e.g., >4 ng/mL rather than lower thresholds). 1

Using PSA as a standalone test: 1, 2

• Digital rectal examination should be performed in conjunction with PSA, as it may identify high-risk cancers associated with "normal" PSA values. 1, 2

Ignoring medication effects: 1, 2

• 5α-reductase inhibitors (finasteride and dutasteride) decrease PSA by approximately 50%, and values must be corrected accordingly. 1, 2