Challenges and Opportunities in Establishing Appropriate Intermediate Endpoints Reflecting Patient Benefit: A Roadmap for Research and Clinical Application in Nonmetastatic Prostate Cancer

Eur Urol. 2024 Aug;86(2):81-87. doi: 10.1016/j.eururo.2024.04.024. Epub 2024 May 18.

Abstract

Defining meaningful endpoints for research of early-stage high-risk prostate cancer is challenging, with established measures such as overall survival and metastasis-free survival facing limitations related to feasibility and adequate reflection of patient relevance. Developing endpoints must cater to diverse perspectives across scientific, clinical, regulatory, and patient viewpoints. Endpoints such as pathological complete response, no evidence of disease, and prevention of prostate-specific antigen relapse may reflect patient benefit by accounting for diagnostic and treatment burdens.

Publication types

  • Editorial

MeSH terms

  • Endpoint Determination
  • Humans
  • Male
  • Prostate-Specific Antigen / blood
  • Prostatic Neoplasms* / pathology
  • Prostatic Neoplasms* / therapy

Substances

  • Prostate-Specific Antigen