Anti-androgen monotherapy versus gonadotropin-releasing hormone agonists in men with advanced, non-metastatic

Frederik Birkebæk Thomsen1, Cecilia Bosco2, Hans Garmo2,3

  • 1a Copenhagen Prostate Cancer Center, Department of Urology , Rigshospitalet, University of Copenhagen , Copenhagen , Denmark.

Abstract

Insights

Men with high-risk prostate cancer (PCa) receiving anti-androgen monotherapy (AA) had lower mortality than those on gonadotropin-releasing hormone (GnRH) agonists. AA therapy did not increase PCa-specific mortality, suggesting potential benefits over GnRH agonists.

Area of Science:

  • Oncology
  • Pharmacology
  • Real-world evidence studies

Background:

  • Randomized controlled trials (RCTs) show similar all-cause mortality for advanced, non-metastatic prostate cancer (PCa) patients treated with anti-androgen monotherapy (AA) versus gonadotropin-releasing hormone (GnRH) agonists.
  • Real-world data is needed to further compare mortality between these treatment categories.

Purpose of the Study:

  • To assess the difference in all-cause and PCa-specific mortality between men with high-risk, non-metastatic PCa treated with AA versus GnRH agonists using real-world data.

Main Methods:

  • A real-world trial emulation using data from Prostate Cancer data Base Sweden 3.0 (2006-2012).
  • Focused on men with high-risk, non-metastatic PCa receiving primary hormonal therapy with AA (n=2078) or GnRH agonists (n=4878).
  • Utilized competing risk analyses and propensity score matching for mortality risk assessment over a median follow-up of 5 years.

Main Results:

  • Cumulative 5-year PCa mortality was lower with AA (16%) compared to GnRH agonists (22%).
  • Cumulative 5-year other-cause mortality was lower with AA (17%) versus GnRH agonists (27%).
  • Regression analyses showed similar PCa death risk (HR 1.08) but higher all-cause mortality risk with GnRH agonists (HR 1.23) versus AA.

Conclusions:

  • Anti-androgen monotherapy (AA) as primary hormonal therapy for high-risk, non-metastatic PCa does not increase PCa-specific mortality compared to GnRH agonists.
  • Using AA may lead to reduced exposure to GnRH-treatment, potentially lowering the risk of associated adverse events.

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