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Background <p>We have demonstrated that patients with prostate-specific antigen failure following radical prostatectomy benefit from salvage radiation therapy prior to salvage hormone therapy in a multicenter, randomized, open-label, phase 3 trial (JCOG0401). This study aimed to develop a nomogram to predict the efficacy of salvage radiation therapy in patients with prostate-specific antigen failure following radical prostatectomy.</p> Methods <p>This exploratory study focused on the salvage radiation therapy arm of the JCOG0401 trial and explored clinical factors that were significantly associated with the time to treatment failure of salvage radiation therapy using univariable and multivariable analyses. Based on these factors, we developed a nomogram to predict 3- and 5-year time to treatment failure. Discrimination and calibration of the nomogram were performed using concordance statistics and calibration plots.</p> Results <p>Ninety-six patients were included in the analysis, with a median time to treatment failure of 4.7&#xa0;years. Multivariable Cox regression analysis identified pathological T stage ≥ 3, lack of lymph node dissection, lack of nerve-sparing, and prostate-specific antigen-doubling time &lt; 6&#xa0;months as significant factors associated with time to treatment failure (P &lt; 0.05 for each). The nomogram including these factors achieved a concordance statistics of 0.6996. The hazard ratio for time to treatment failure was 2.946 (95% confidence interval 1.624–5.347), when the cut-off value of the nomogram was determined as the median nomogram score.</p> Conclusions <p>The developed nomogram enables moderate prediction of the efficacy of salvage radiation therapy in patients with prostate-specific antigen recurrence following radical prostatectomy.</p>

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Nomogram predicting the outcome of salvage radiation therapy for prostate-specific antigen failure following radical prostatectomy: an exploratory analysis of a randomized, multicenter, open-label, phase 3 trial (JCOG0401)

  • 期刊论文

  • 发表日期：

    2025年3月8日

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  • Yoichiro Tohi,
  • Akira Yokomizo,
  • Takahiro Kimura,
  • Masashi Wakabayashi,
  • Masaki Shiota,
  • Keiichiro Mori,
  • Takuma Kato,
  • Toyonori Tsuzuki,
  • Masashi Kato,
  • Keita Sasaki,
  • Takashi Kawahara,
  • Masatoshi Eto,
  • Hiroyuki Nishiyama,
  • Hiroshi Kitamura,
  • Mikio Sugimoto

摘要

Background

We have demonstrated that patients with prostate-specific antigen failure following radical prostatectomy benefit from salvage radiation therapy prior to salvage hormone therapy in a multicenter, randomized, open-label, phase 3 trial (JCOG0401). This study aimed to develop a nomogram to predict the efficacy of salvage radiation therapy in patients with prostate-specific antigen failure following radical prostatectomy.

Methods

This exploratory study focused on the salvage radiation therapy arm of the JCOG0401 trial and explored clinical factors that were significantly associated with the time to treatment failure of salvage radiation therapy using univariable and multivariable analyses. Based on these factors, we developed a nomogram to predict 3- and 5-year time to treatment failure. Discrimination and calibration of the nomogram were performed using concordance statistics and calibration plots.

Results

Ninety-six patients were included in the analysis, with a median time to treatment failure of 4.7 years. Multivariable Cox regression analysis identified pathological T stage ≥ 3, lack of lymph node dissection, lack of nerve-sparing, and prostate-specific antigen-doubling time < 6 months as significant factors associated with time to treatment failure (P < 0.05 for each). The nomogram including these factors achieved a concordance statistics of 0.6996. The hazard ratio for time to treatment failure was 2.946 (95% confidence interval 1.624–5.347), when the cut-off value of the nomogram was determined as the median nomogram score.

Conclusions

The developed nomogram enables moderate prediction of the efficacy of salvage radiation therapy in patients with prostate-specific antigen recurrence following radical prostatectomy.