Survival modelling of relapse-free survival and competing-risk analysis in patients with high-risk localized prostate cancer treated in GETUG-12.

Clinical Snapshot

Key Findings

• P Value: Not explicitly stated but CIs suggest statistical significance

• Effect Size: HR 0.49 for second events in patients with ≥3 years vs <3 years to biochemical progression

• Primary Outcome: Relapse-free survival analyzed using piecewise-exponential model with two time intervals

• Nnt Or Sensitivity: Sub-hazard ratio 0.41 for metastases development in late vs early biochemical progression

• Confidence Interval: 95% CI 0.30-0.79 for second events; 95% CI 0.23-0.73 for metastases

Clinical Application

Docetaxel and estramustine combination requires oncology expertise and monitoring for toxicity Relevant to Australian practice; docetaxel is PBS-listed for prostate cancer, though estramustine use has declined. Findings support current NCCN and EAU guidelines adopted in Australia Men with high-risk localized prostate cancer receiving ADT and radiotherapy

Abstract

BACKGROUND: Androgen-deprivation therapy (ADT) plus radiotherapy is a standard of care for men with high-risk localized prostate cancer (PC). Adding docetaxel in this setting demonstrated better relapse-free survival (RFS) but not survival. Few data are available on relapse patterns. Our aim was to investigate whether different patterns of relapses exist in men with high-risk localized PC. PATIENTS AND METHODS: Prospective data from the GETUG12 phase 3 randomized controlled trial comparing ADT alone vs ADT + docetaxel and estramustine (DE) was examined. RFS (main endpoint) was analysed using parametric survival models and second event-free survival (SEFS) defined from biochemical progression (BP) was analysed using a competing-risk approach. RESULTS: Overall, 413 patients were randomized from 2002 to 2006, 206 treated with ADT and 207 with ADT+DE, in addition to local treatment. First analysis showed that the piecewise-exponential model with two time-intervals ([0-3[; ≥3 years) was the model that best characterized RFS with no time-dependent effect of risk factors and treatment. Second analyses limited to patients with a BP showed that the risk of a second event was significantly lower in patients with a longer time-interval from randomization to BP (hazard ratio (HR≥ 3 versus < 3 years): 0.49 [95% CI 0.30-0.79]). In competing-risk analysis, a significant and protective effect of this time-interval was observed for metastases (sub-HR≥ 3 versus < 3 years: 0.41 [0.23-0.73] accounting for salvage treatment. CONCLUSION: Time-interval from randomization to BP is a major prognostic factor for developing local or distant recurrences for patients with high-risk localized PC.

References

1. 1.Vicier, C., Erdogan, F., Allouache, N., Delva, R., Gravis, G., Rolland, F., Priou, F., Ferrero, J. M., Houede, N., Mourey, L., Theodore, C., Krakowski, I., Berdah, J. F., Baciuchka, M., Laguerre, B., Fléchon, A., Gross-Goupil, M., Cojean-Zelek, I., Oudard, S., ... Le Teuff, G. (2026). Survival modelling of relapse-free survival and competing-risk analysis in patients with high-risk localized prostate cancer treated in GETUG-12. European Journal of Cancer, 116678. https://doi.org/10.1016/j.ejca.2026.116678