Skip to content
Bending the Curve Trial by Trial
?

PROSELICA

Phase III Study Comparing a Reduced Dose of Cabazitaxel (20 mg/m2) and the Currently Approved Dose (25 mg/m2) in Postdocetaxel Patients With Metastatic Castration-Resistant Prostate Cancer-PROSELICA

Phase 3N = 1,200NCT01308580

Population
Postdocetaxel patients with metastatic castration-resistant prostate cancer
Design
Randomized phase 3 non-inferiority trial of cabazitaxel 20 mg/m2 (C20) versus 25 mg/m2 (C25). Non-inferiority was defined as C20 keeping at least 50% of the overall survival benefit of C25 versus mitoxantrone in TROPIC: the upper boundary of the hazard ratio CI could not exceed 1.214 under a one-sided 98.89% CI after interim analyses.
Primary endpoint
OS
Arms
  • Cabazitaxel 25 mg/m2 (control, n = 602): Cabazitaxel 25 mg/m2
  • Cabazitaxel 20 mg/m2 (experimental, n = 598): Cabazitaxel 20 mg/m2
People
Eisenberger M, PROSELICA
OSHR 1.024Δ median OS−1.1 months
Show the numbers
Results reported for PROSELICA
EndpointAnalysisCabazitaxel 20 mg/m2Cabazitaxel 25 mg/m2Effect
OSRandomized patients (analysis population not stated in the abstract)primaryEisenberger 2017median 13.4 monthsmedian 14.5 monthsHR 1.024Hazard ratio of C20 versus C25. The abstract gives only the upper boundary of the confidence interval, 1.184, which is below the non-inferiority margin of 1.214. The abstract does not state the C20-versus-C25 comparison as superior or inferior.
Results reported for PROSELICA
EndpointAnalysisCabazitaxel 20 mg/m2Cabazitaxel 25 mg/m2Effect
OSRandomized patients (analysis population not stated in the abstract)primaryEisenberger 2017median 13.4 monthsmedian 14.5 monthsHR 1.024Hazard ratio of C20 versus C25. The abstract gives only the upper boundary of the confidence interval, 1.184, which is below the non-inferiority margin of 1.214. The abstract does not state the C20-versus-C25 comparison as superior or inferior.
Illustrative — modelled from reported values, not trial data. OS, primary.
0%25%50%75%100%0102030Months (modelled)
  • Cabazitaxel 25 mg/m2 (control)
  • Cabazitaxel 20 mg/m2 (experimental)

Median-only curves assume a constant hazard (exponential) and fit plateaus, as seen with some immunotherapies, poorly.

Data table (modelled values)
MonthsCabazitaxel 25 mg/m2Cabazitaxel 20 mg/m2
0100.0%100.0%
965.0%62.8%
1842.3%39.4%
2727.5%24.7%
3617.9%15.5%
Primary publication: Eisenberger M, Hardy-Bessard AC, Kim CS, Géczi L, Ford D, Mourey L, et al. Phase III Study Comparing a Reduced Dose of Cabazitaxel (20 mg/m(2)) and the Currently Approved Dose (25 mg/m(2)) in Postdocetaxel Patients With Metastatic Castration-Resistant Prostate Cancer-PROSELICA. J Clin Oncol. 2017;35(28):3198-3206. PubMedDOI

Appears in

Sources

  1. Eisenberger M, Hardy-Bessard AC, Kim CS, Géczi L, Ford D, Mourey L, et al. Phase III Study Comparing a Reduced Dose of Cabazitaxel (20 mg/m(2)) and the Currently Approved Dose (25 mg/m(2)) in Postdocetaxel Patients With Metastatic Castration-Resistant Prostate Cancer-PROSELICA. J Clin Oncol. 2017;35(28):3198-3206.

    PubMedDOI