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

  • 0Department of Urology, Ludwig-Maximilians University Munich, Munich, Germany; Janssen Research and Development, Spring House, PA, USA.
European Urology +

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May 18, 2024

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May 18, 2024

View abstract on PubMed

Summary

This summary is machine-generated.

Defining research endpoints for high-risk prostate cancer is difficult. New measures like pathological complete response may better reflect patient benefit and reduce treatment burdens.

Area Of Science

  • Oncology
  • Clinical Research
  • Prostate Cancer Research

Background

  • Established endpoints for early-stage high-risk prostate cancer, such as overall survival and metastasis-free survival, have limitations in feasibility and patient relevance.
  • Research in this area requires endpoints that consider scientific, clinical, regulatory, and patient perspectives.

Discussion

  • The limitations of traditional endpoints necessitate the development of novel measures.
  • Alternative endpoints should aim to capture a more comprehensive understanding of patient benefit.

Key Insights

  • Pathological complete response, no evidence of disease, and prevention of prostate-specific antigen relapse are potential alternative endpoints.
  • These endpoints may better account for the burdens associated with diagnosis and treatment.
  • Considering patient-reported outcomes and quality of life is crucial.

Outlook

  • Further validation of these novel endpoints is required.
  • The development of standardized, patient-centric endpoints will improve clinical trial design and regulatory evaluation.
  • Future research should focus on incorporating diverse stakeholder input for endpoint selection.