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Related Experiment Videos

Phase II studies on prostate cancer

F H Schröder1, U Norming, B A Blumenstein

  • 1Department of Urology, Erasmus University, Rotterdam, The Netherlands.

Urology
|April 1, 1997
PubMed
Summary

Phase II trials for prostate cancer need better designs. Using serum prostate-specific antigen (PSA) and softer endpoints may improve drug evaluation, potentially replacing some traditional phase II studies.

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Area of Science:

  • Oncology
  • Clinical Trial Design

Background:

  • Phase II trials are crucial for evaluating new cancer treatments.
  • Traditional phase II trial designs face limitations in assessing prostate cancer, particularly skeletal metastases.

Purpose of the Study:

  • To evaluate diverse study designs for phase II trials in prostate cancer.
  • To assess the overall utility and applicability of phase II trials in this field.

Main Methods:

  • A comprehensive literature review and expert consensus were compiled.
  • Analysis focused on traditional versus novel endpoints and statistical designs.

Main Results:

  • Phase II trials aim to confirm treatment activity and assess adverse reactions.
  • Skeletal metastases in prostate cancer limit traditional response assessments.

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  • Serum prostate-specific antigen (PSA) and World Health Organization criteria for adverse reactions are proposed alternatives.

    • Conclusions:

    • The role of PSA in phase II trials requires further validation.
    • Softer endpoints and early phase III studies may enhance drug evaluation in prostate cancer.
    • Adaptable phase II trial designs are essential for advancing prostate cancer therapeutics.