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

Publication ,  Journal Article
D'Amico, AV; Moul, JW; Carroll, PR; Sun, L; Lubeck, D; Chen, M-H
Published in: J Natl Cancer Inst
September 17, 2003

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.

Duke Scholars

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Published In

J Natl Cancer Inst

DOI

EISSN

1460-2105

Publication Date

September 17, 2003

Volume

95

Issue

18

Start / End Page

1376 / 1383

Location

United States

Related Subject Headings

  • Treatment Outcome
  • Time Factors
  • Survival Analysis
  • Prostatic Neoplasms
  • Prostatectomy
  • Prostate-Specific Antigen
  • Proportional Hazards Models
  • Predictive Value of Tests
  • Oncology & Carcinogenesis
  • Odds Ratio
 

Citation

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D’Amico, A. V., Moul, J. W., Carroll, P. R., Sun, L., Lubeck, D., & Chen, M.-H. (2003). Surrogate end point for prostate cancer-specific mortality after radical prostatectomy or radiation therapy. J Natl Cancer Inst, 95(18), 1376–1383. https://doi.org/10.1093/jnci/djg043
D’Amico, Anthony V., Judd W. Moul, Peter R. Carroll, Leon Sun, Deborah Lubeck, and Ming-Hui Chen. “Surrogate end point for prostate cancer-specific mortality after radical prostatectomy or radiation therapy.J Natl Cancer Inst 95, no. 18 (September 17, 2003): 1376–83. https://doi.org/10.1093/jnci/djg043.
D’Amico AV, Moul JW, Carroll PR, Sun L, Lubeck D, Chen M-H. Surrogate end point for prostate cancer-specific mortality after radical prostatectomy or radiation therapy. J Natl Cancer Inst. 2003 Sep 17;95(18):1376–83.
D’Amico, Anthony V., et al. “Surrogate end point for prostate cancer-specific mortality after radical prostatectomy or radiation therapy.J Natl Cancer Inst, vol. 95, no. 18, Sept. 2003, pp. 1376–83. Pubmed, doi:10.1093/jnci/djg043.
D’Amico AV, Moul JW, Carroll PR, Sun L, Lubeck D, Chen M-H. Surrogate end point for prostate cancer-specific mortality after radical prostatectomy or radiation therapy. J Natl Cancer Inst. 2003 Sep 17;95(18):1376–1383.
Journal cover image

Published In

J Natl Cancer Inst

DOI

EISSN

1460-2105

Publication Date

September 17, 2003

Volume

95

Issue

18

Start / End Page

1376 / 1383

Location

United States

Related Subject Headings

  • Treatment Outcome
  • Time Factors
  • Survival Analysis
  • Prostatic Neoplasms
  • Prostatectomy
  • Prostate-Specific Antigen
  • Proportional Hazards Models
  • Predictive Value of Tests
  • Oncology & Carcinogenesis
  • Odds Ratio