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Surrogate Endpoints in Localized Prostate Cancer.

Holly E Hartman, William C Jackson1

  • 1Radiation Oncology, University of Michigan, Ann Arbor, MI.

Cancer Journal (Sudbury, Mass.)
|January 25, 2020
PubMed
Summary

Metastasis-free survival is a validated surrogate endpoint for overall survival in localized prostate cancer clinical trials. This finding can accelerate the evaluation of new treatments, ensuring timely access to improved therapies for patients.

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Area of Science:

  • Oncology
  • Clinical Trials
  • Prostate Cancer Research

Background:

  • Randomized clinical trials for localized prostate cancer often require extensive patient enrollment and over a decade of follow-up to confirm overall survival benefits.
  • The rapidly evolving treatment landscape risks rendering trial results obsolete by publication.
  • There is a critical need for earlier endpoints that accurately predict overall survival.

Purpose of the Study:

  • To review data on surrogate endpoints for localized prostate cancer.
  • To validate metastasis-free survival as a reliable surrogate for overall survival in this patient population.
  • To address the challenges posed by long follow-up periods in prostate cancer clinical trials.

Main Methods:

  • Review of relevant data concerning surrogate endpoints in localized prostate cancer.
  • Analysis of findings from the Intermediate Clinical Endpoints in Cancer of the Prostate Working Group.
  • Evaluation of metastasis-free survival as a potential surrogate endpoint.

Main Results:

  • Metastasis-free survival has been identified as a valid surrogate endpoint.
  • This endpoint can be assessed earlier in the disease course compared to overall survival.
  • The findings support the use of metastasis-free survival in clinical trial design.

Conclusions:

  • Metastasis-free survival serves as a robust surrogate for overall survival in localized prostate cancer.
  • Utilizing this endpoint can expedite the assessment of novel therapies.
  • This approach helps overcome limitations of long follow-up durations in clinical trials.