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

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...

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Bibliographic Details
Published in:European urology 2024-08, Vol.86 (2), p.81-87
Main Authors: Brookman-May, Sabine D., Buyse, Marc, Freedland, Stephen J., Miladinovic, Branko, Zhang, Ke, Fendler, Wolfgang P., Feng, Felix, Sartor, Oliver, Sweeney, Christopher J.
Format: Article
Language:English
Subjects:
Endpoint Determination
Humans
Male
Prostate-Specific Antigen - blood
Prostatic Neoplasms - pathology
Prostatic Neoplasms - therapy
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Summary: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.
ISSN:0302-2838
1873-7560
1873-7560
DOI:10.1016/j.eururo.2024.04.024