Skip to main content

Thank you for visiting nature.com. You are using a browser version with limited support for CSS. To obtain the best experience, we recommend you use a more up to date browser (or turn off compatibility mode in Internet Explorer). In the meantime, to ensure continued support, we are displaying the site without styles and JavaScript.

  • News & Views
  • Published:

Prostate cancer

PSA as an intermediate end point in clinical trials

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.

This is a preview of subscription content, access via your institution

Relevant articles

Open Access articles citing this article.

Access options

Buy this article

Prices may be subject to local taxes which are calculated during checkout

References

  1. Hussain, M. et al. Prostate-specific antigen progression predicts overall survival in patients with metastatic prostate cancer: data from Southwest Oncology Group Trials 9346 (Intergroup Study 0162) and 9916. J. Clin. Oncol. 27, 2450–2456 (2009).

    Article  PubMed  PubMed Central  Google Scholar 

  2. Petrylak, D. P. et al. Evaluation of prostate-specific antigen declines for surrogacy in patients treated on SWOG 99–16. J. Natl Cancer Inst. 98, 516–521 (2006).

    Article  PubMed  Google Scholar 

  3. Armstrong, A. J. et al. Prostate-specific antigen and pain surrogacy analysis in metastatic hormone-refractory prostate cancer. J. Clin. Oncol. 25, 3965–3970 (2007).

    Article  PubMed  Google Scholar 

  4. Scher, H. I. et al. Design and end points of clinical trials for patients with progressive prostate cancer and castrate levels of testosterone: recommendations of the Prostate Cancer Clinical Trials Working Group. J. Clin. Oncol. 26, 1148–1159 (2008).

    Article  PubMed  Google Scholar 

  5. Bubley, G. J. et al. Eligibility and response guidelines for phase II clinical trials in androgen-independent prostate cancer: recommendations from the Prostate-Specific Antigen Working Group. J. Clin. Oncol. 17, 3461–3467 (1999).

    Article  CAS  PubMed  Google Scholar 

  6. Halabi, S. et al. Progression-free survival as a predictor of overall survival in men with castrate-resistant prostate cancer. J. Clin. Oncol. 27, 2766–2771 (2009).

    Article  PubMed  PubMed Central  Google Scholar 

  7. Collette, L. et al. Is prostate-specific antigen a valid surrogate end point for survival in hormonally treated patients with metastatic prostate cancer? Joint research of the European Organisation for Research and Treatment of Cancer, the Limburgs Universitair Centrum, and AstraZeneca Pharmaceuticals. J. Clin. Oncol. 23, 6139–6148 (2005).

    Article  PubMed  Google Scholar 

  8. de Bono, J. S. et al. Circulating tumor cells predict survival benefit from treatment in metastatic castration-resistant prostate cancer. Clin. Cancer Res. 14, 6302–6309 (2008).

    Article  CAS  PubMed  Google Scholar 

  9. Attard, G. et al. Characterization of ERG, AR and PTEN gene status in circulating tumor cells from patients with castration-resistant prostate cancer. Cancer Res. 69, 2912–2918 (2009).

    Article  CAS  PubMed  Google Scholar 

  10. Parmar, M. K. et al. Speeding up the evaluation of new agents in cancer. J. Natl Cancer Inst. 100, 1204–1212 (2008).

    Article  CAS  PubMed  PubMed Central  Google Scholar 

Download references

Acknowledgements

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.

Author information

Authors and Affiliations

Authors

Corresponding author

Correspondence to Johann S. de Bono.

Ethics declarations

Competing interests

The authors declare no competing financial interests.

Rights and permissions

Reprints and permissions

About this article

Cite this article

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

Download citation

  • Issue Date:

  • DOI: https://doi.org/10.1038/nrurol.2009.130

This article is cited by

Search

Quick links

Nature Briefing

Sign up for the Nature Briefing newsletter — what matters in science, free to your inbox daily.

Get the most important science stories of the day, free in your inbox. Sign up for Nature Briefing