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A Bioluminescent and Fluorescent Orthotopic Syngeneic Murine Model of Androgen-dependent and Castration-resistant Prostate Cancer
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The State of Intermediate Clinical Endpoints as Surrogates for Overall Survival in Prostate Cancer in 2024
Marcin Miszczyk1, Paweł Rajwa2, Tamás Fazekas3
1Department of Urology, Comprehensive Cancer Center, Medical University of Vienna, Vienna, Austria; Collegium Medicum - Faculty of Medicine, WSB University, Dąbrowa Górnicza, Poland.
European Urology Oncology
|April 25, 2024
Summary
Metastasis-free survival is a valid intermediate clinical endpoint (ICE) for localized prostate cancer (PCa) trials. For advanced PCa, some ICEs exist but require further validation for broader use in clinical research.
Area of Science:
- Oncology
- Clinical Trials
- Biostatistics
Background:
- Historically, intermediate clinical endpoints (ICEs) in prostate cancer (PCa) trials relied on qualitative measures.
- Current research standards demand robust correlation between ICEs and overall survival (OS).
Purpose of the Study:
- To review high-quality meta-analyses validating ICEs as surrogates for OS in prostate cancer.
- To assess the reliability of various ICEs across different stages of PCa.
Main Methods:
- Systematic review of existing meta-analyses on ICEs in PCa.
- Analysis of data quality and generalizability for surrogate endpoint validation.
Main Results:
- Strong evidence supports metastasis-free survival as a valid ICE for localized PCa.
- In metastatic hormone-sensitive PCa, radiological and clinical progression-free survival are identified as potential ICEs.
- Concerns exist regarding the generalizability of data used to validate ICEs in advanced PCa.
Conclusions:
- Metastasis-free survival is a reliable ICE for localized prostate cancer.
- Further research is needed to confirm the generalizability and utility of ICEs in advanced prostate cancer, particularly metastatic hormone-sensitive PCa.
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