Last updated on December 2018

Trial Evaluating the Safety of 2 Schedules of Cabazitaxel in Elderly Men With mCRPC Previously Treated With a Docetaxel

Brief description of study

The purpose of this study is to evaluate the incidence of grade 3 neutropenia and/or neutropenic complications (febrile neutropenia, neutropenic infection) with two schedules of cabazitaxel (bi-weekly versus tri-weekly) plus prednisone in elderly men ( 70 years) with mCRPC previously treated with a docetaxel-containing regimen.

Detailed Study Description

Randomized, open-label, phase 3 trial in mCRPC patients aged 70 years.

  • Arm A : cabazitaxel 25 mg/m on Day 1 of a 3-week cycle plus daily prednisone or
  • Arm B: cabazitaxel 16 mg/m on Day 1 and Day 15 of a 4-week cycle plus daily prednisone.
  • Treatment will be continued for a maximum of 10 cycles unless there is documented disease progression or unacceptable toxicity.
  • Standard cabazitaxel premedication will be used
  • Prophylactic G-CSF (GRANOCYTE) will be injected from Day 3 to Day 7 after every cycle of cabazitaxel if neutrophil count is> 2000/mm3, only 3 days).
  • All new hormonal treatment, including ODM-201, prior to study entry is allowed.
  • Patients who received Radium-223 are eligible for this study
  • Treatment with LHRH should not be discontinued.

Exploratory assessments:

CT-Scan (abdominal/pelvic/chest) or whole body MRI and Bone scan: at screening, every 3 months and EOT.

FACT-P questionnaire:at C1D1,each subsequent visit and EOT

Number of subjects:

Total:170 (85 per arm)

Statistical analysis:

A sample size of 77 evaluable patients per arm will achieve 80% power to detect a 20% difference in G3 neutropenia incidence between the 2 arms. The incidence in group cabazitaxel 25 mg/m2 q3w is assumed to be 32% and 12% on bi-weekly cabazitaxel arm. The test used is a two-sided Fisher's exact test at 0.05 significance level. Assuming 10% non-evaluable patients, 85 patients should be included in each arm for a total of 170. Patients will be stratified according to G8 score and previous ARtargeted agent (abiraterone or enzalutamide) before randomization.

Clinical Study Identifier: NCT02961257

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