NCT03934840

CASCARA: Castration Sensitive Carboplatin, Cabazitaxel and Abiraterone

A Phase II Study of Carboplatin, Cabazitaxel and Abiraterone in High Volume Metastatic Castration Sensitive Prostate Cancer

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 22 (actual)
• Sponsor: Masonic Cancer Center, University of Minnesota · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
DRUG	Cabazitaxel	20 mg/m2 Q 21 days
DRUG	Carboplatin	AUC 4 Q21 Days x 6 cycles with ADT
DRUG	Abiraterone	1000 mg PO daily
DRUG	Prednisone	5 mg PO daily on chemotherapy completion

Timeline

• Start date: 2019-10-10
• Primary completion: 2023-06-19
• Completion: 2025-05-01
• First posted: 2019-05-02
• Last updated: 2024-02-28

Locations

8 sites across 1 country: United States

Regulatory

• FDA-regulated drug study