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NEJM EvidenceMeta-Analysis of Candidate Surrogate End Points in Advanced Prostate Cancer

Are we overlooking an undiscovered metric in advanced prostate cancer that could change the way we predict overall survival?

In the quest to uncover valid surrogate end points for overall survival in advanced prostate cancer, recent research unveils surprising findings, leaving more questions than answers.

Key Points:

  • The Intermediate Clinical Endpoints in Cancer of the Prostate (ICECaP) working group previously identified metastasis-free survival as a valid surrogate end point for overall survival (OS) in localized prostate cancer.
  • In this study, researchers conducted a comprehensive review of 143 randomized trials (involving 75,601 patients) targeting advanced prostate cancer, encompassing different disease stages and treatment types.
  • No candidate end points, including biochemical failure (BF), biochemical failure–free survival (BFS), clinical failure, progression-free survival (PFS), and radiographic PFS, met the criteria for surrogacy.

Additional Points:

  • Candidacy for surrogacy was assessed using the meta-analytic approach, defining suitable surrogate markers as those with an R2 value over 0.70.
  • BFS and PFS, considered in castration-sensitive or castration-resistant disease subgroups and across treatment types, failed to consistently meet the surrogacy criteria.
  • Surrogacy candidacy for all tested end points showed no variation over time.


  • The results suggest that the commonly used clinical end points in advanced prostate cancer are not valid surrogate markers for overall survival, emphasizing the need for further research in this area.

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Did You Know?
As of 2021, prostate cancer is the second most common cancer among men worldwide.

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