The 2009 study by Hussain et al. showed that a PSA-based intermediate end point might be useful in clinical trials of advanced prostate cancer. However, overall survival (OS) will remain the required end point of phase III studies and the search for a true, robust surrogate of OS to accelerate drug development continues.
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We acknowledge Roger A'Hern in the Cancer Research UK Section of Clinical Trials, The Institute of Cancer Research, Sutton, Surrey, UK, for advising us on the contents of this manuscript.
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Attard, G., de Bono, J. PSA as an intermediate end point in clinical trials. Nat Rev Urol 6, 473–475 (2009). https://doi.org/10.1038/nrurol.2009.130
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DOI: https://doi.org/10.1038/nrurol.2009.130
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