At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Randomized Multicenter, Phase III Trial Evaluating the Safety of 2 Schedules of Cabazitaxel (Bi-weekly Versus Tri-weekly) Plus Prednisone in Elderly Men (≥ 65years) With mCRPC Previously Treated With a Docetaxel-containing Regimen
In Brief
A Phase 3 clinical trial evaluating cabazitaxel, Prednisone, and 1 other intervention for Prostate Cancer Metastatic. Completed, enrolled 196 participants across 31 sites in 2 countries.
Detailed Summary
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 (≥ 65 years) with mCRPC previously treated with a docetaxel-containing regimen.
Study Details
Timeline
Interventions
* Arm A : cabazitaxel 25 mg/m² on Day 1 of a 3-week cycle plus daily prednisone or * Arm B: cabazitaxel 16 mg/m² 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
Arm A:plus prednisone 10 mg orally given daily for a maximum of 10 cycles Arm B: plus prednisone 10 mg orally given per day up to 10 cycles
Primary prophylaxis with Granulocyte Colony-Stimulating Factor (G-CSF) will be injected from Day 3 to Day 7 after every administration of cabazitaxel