At a glance
ClinicalIndex Comparison Record- ✓Histologically confirmed prostate cancer
- ✓High volume metastatic disease defined as visceral metastases or ≥3 bone lesions
- ✓ADT for ≤3 months prior to day 1 of study chemotherapy; prior ADT courses allowed
- ✓Testosterone <50 ng/dL with continuation of primary ADT if no orchiectomy
- ✕Prior exposure to chemotherapy, PARPi, or immunotherapy for prostate cancer
- ✕Prior abiraterone or enzalutamide, unless therapy was for <2 weeks
- ✕Radiation therapy within 14 days or major surgery within 28 days of first dose
- ✕Other systemic prostate cancer therapies within 28 days or 5 half-lives (whichever shorter) before day 1, except anti-androgens like bicalutamide
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase II Study of Carboplatin, Cabazitaxel and Abiraterone in High Volume Metastatic Castration Sensitive Prostate Cancer
In Brief
A Phase 2 clinical trial evaluating Cabazitaxel, Carboplatin, and 2 other interventions for Prostate Cancer. Completed, enrolled 61 participants across 8 sites.
Detailed Summary
This is a phase II clinical trial in patients with metastatic castration sensitive prostate cancer. The objective of the study is to determine the efficacy and further define the safety of the treatment combination. This study will evaluate dose levels of carboplatin AUC 4 with cabazitaxel 20 mg/m2. Patients will be treated with the combination of ADT and carboplatin and cabazitaxel for 6 cycles. After 6 cycles of chemotherapy, they will start abiraterone with ADT. The primary objective is to determine the percent of subjects that have no PSA or radiographic progression at 1 year. Secondary objectives will include determining the progression-free survival, time to PSA nadir and time to PSA progression of carboplatin and cabazitaxel in combination with ADT.
Study Details
Timeline
Interventions
20 mg/m2 Q 21 days
AUC 4 Q21 Days x 6 cycles with ADT
1000 mg PO daily
5 mg PO daily on chemotherapy completion