Monitoring of prostate-specific antigen in men with benign prostate enlargement receiving 5-alpha reductase inhibitors: a non-interventional, cross-sectional study of real-world practice of urologists in Spain and Brazil

BMC Urol. 2025 Jan 31;25(1):22. doi: 10.1186/s12894-025-01701-1.

Abstract

Background: Inconsistent monitoring of prostate-specific antigen in patients receiving 5-alpha reductase inhibitors for lower urinary tract symptoms/benign prostate enlargement may affect prostate cancer outcomes. This study evaluated real-world practice among urologists treating patients receiving 5-alpha reductase inhibitors.

Methods: This non-interventional, cross-sectional study collected data from urologists in Spain (N = 100) and Brazil (N = 100) via a self-reporting questionnaire and patient record forms. Endpoints included: frequency/methodology of prostate-specific antigen monitoring, concerns about the effect of 5-alpha reductase inhibitors on prostate-specific antigen monitoring, triggers of prostate biopsy, and concerns when switching 5-alpha reductase inhibitor formulation.

Results: Over half of urologists monitored prostate-specific antigen every 6 months (Spain 59%, Brazil 58%). Preferred methods were the "doubling rule" (Spain 66%, Brazil 41%) and "increase from nadir" (Spain 28%, Brazil 43%). A minority of urologists monitored unadjusted values (Spain 3%, Brazil 11%) or did not monitor prostate-specific antigen (Spain 1%, Brazil 3%). Most urologists ranked the potential for 5-alpha reductase inhibitors to mask prostate cancer as their top concern (Spain 65%, Brazil 56%). The most selected trigger for prostate biopsy was "if doubled (adjusted) prostate-specific antigen level after 6 months of treatment is > 4 ng/mL" (Spain 39%, Brazil 37%). Many urologists were moderately/very concerned about the effect on prostate-specific antigen when switching 5-alpha reductase inhibitor formulation.

Conclusions: An unmet need exists for standard guidance and continuous education to support optimal monitoring and interpretation of prostate-specific antigen in patients with lower urinary tract symptoms/benign prostate enlargement treated with 5-alpha reductase inhibitors.

Keywords: 5-alpha reductase inhibitors; Benign prostate enlargement; Benign prostatic hyperplasia; Prostate-specific antigen; Real-world data.

MeSH terms

  • 5-alpha Reductase Inhibitors* / therapeutic use
  • Aged
  • Brazil
  • Cross-Sectional Studies
  • Humans
  • Male
  • Middle Aged
  • Practice Patterns, Physicians'*
  • Prostate-Specific Antigen* / blood
  • Prostatic Hyperplasia* / blood
  • Prostatic Hyperplasia* / diagnosis
  • Prostatic Hyperplasia* / drug therapy
  • Spain
  • Urologists*
  • Urology

Substances

  • Prostate-Specific Antigen
  • 5-alpha Reductase Inhibitors