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.
European urology. 2024 May 17 [Epub ahead of print]
Sabine D Brookman-May, Marc Buyse, Stephen J Freedland, Branko Miladinovic, Ke Zhang, Wolfgang P Fendler, Felix Feng, Oliver Sartor, Christopher J Sweeney
Department of Urology, Ludwig-Maximilians University Munich, Munich, Germany; Janssen Research and Development, Spring House, PA, USA. Electronic address: ., Data Science Institute, Interuniversity Institute for Biostatistics and statistical Bioinformatics (I-Biostat), University of Hasselt, Hasselt, Belgium; International Drug Development Institute, Louvain-la-Neuve, Belgium., Department of Urology, Cedars-Sinai Medical Center, Los Angeles, CA, USA; Section of Urology, Durham VA Medical Center, Durham, NC, USA., Janssen Research and Development, San Diego, CA, USA., Department of Nuclear Medicine, University of Duisburg-Essen and German Cancer Consortium (DKTK)-University Hospital Essen, Essen, Germany., Department of Medicine, UCSF, San Francisco, CA, USA; Department of Urology, UCSF, San Francisco, CA, USA; Department of Radiation Oncology, UCSF, San Francisco, CA, USA., Mayo Clinic, Rochester, MN, USA., South Australian Immunogenomics Cancer Institute, University of Adelaide, Adelaide, Australia.