Surrogate end point for prostate cancer-specific mortality after radical prostatectomy or radiation therapy.

Published

Journal Article

BACKGROUND: The relationship between prostate-specific antigen (PSA)-defined recurrence and prostate cancer-specific mortality remains unclear. Therefore, we evaluated the hypothesis that a short post-treatment PSA doubling time (PSA-DT) after radiation therapy is a surrogate end point for prostate cancer-specific mortality by analyzing two multi-institutional databases. METHODS: Baseline, treatment, and follow-up information was compiled on a cohort of 8669 patients with prostate cancer treated with surgery (5918 men) or radiation (2751 men) from January 1, 1988, through January 1, 2002, for localized or locally advanced, non-metastatic prostate cancer. We used a Cox regression analysis to test whether the post-treatment PSA-DT was a prognostic factor that was independent of treatment received. All statistical tests were two-sided. RESULTS: The post-treatment PSA-DT was statistically significantly associated with time to prostate cancer-specific mortality and with time to all-cause mortality (all P(Cox)<.001). However, the treatment received was not statistically significantly associated with time to prostate cancer-specific mortality after PSA-defined disease recurrence for patients with a PSA-DT of less than 3 months (P(Cox) =.90) and for patients with a PSA-DT of 3 months or more (P(Cox) =.28) when controlling for the specific value of the PSA-DT. Furthermore, after a PSA-defined recurrence, a PSA-DT of less than 3 months was statistically significantly associated with time to prostate cancer-specific mortality (median time = 6 years; hazard ratio = 19.6, 95% confidence interval = 12.5 to 30.9). CONCLUSION: A post-treatment PSA-DT of less than 3 months and the specific value of the post-treatment PSA-DT when it is 3 months or more appear to be surrogate end points for prostate cancer-specific mortality after surgery or radiation therapy. We recommend that consideration be given to initiating androgen suppression therapy at the time of a PSA-defined recurrence when the PSA-DT is less than 3 months to delay the imminent onset of metastatic bone disease.

Full Text

Duke Authors

Cited Authors

  • D'Amico, AV; Moul, JW; Carroll, PR; Sun, L; Lubeck, D; Chen, M-H

Published Date

  • September 2003

Published In

Volume / Issue

  • 95 / 18

Start / End Page

  • 1376 - 1383

PubMed ID

  • 13130113

Pubmed Central ID

  • 13130113

Electronic International Standard Serial Number (EISSN)

  • 1460-2105

International Standard Serial Number (ISSN)

  • 0027-8874

Digital Object Identifier (DOI)

  • 10.1093/jnci/djg043

Language

  • eng