Phase I Trial of PACE for Metastatic Prostate Cancer

Status Withdrawn

Clinical Trial Summary

This trial is being conducted to determine the feasibility and recommended dose of the combination of four drugs (prednisone, abiraterone, cabazitaxel and enzalutamide (PACE) as first-line therapy for metastatic castration-resistant prostate cancer (mCRPC).

Clinical Trial Description

Multiple agents have been shown to improve survival in patients with mCRPC by up to five months. The combination of prednisone, abiraterone, cabazitaxel and enzalutamide may be anticipated to be feasible therapy with minimal or no adverse drug interactions. This is a phase I trial to study the feasibility of the proposed therapy. Patients will undergo a combination of oral daily drug intake at varying doses over a period of three weeks. Monitoring including blood collection for laboratory testing will be done on Day 1 of each three-week cycle with additional monitoring during the first cycle. Imaging and correlative studies will be done every 12 weeks. Therapy will continue until disease progression or severe toxicities. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03110588
Study type	Interventional
Source	University of Alabama at Birmingham
Contact
Status	Withdrawn
Phase	Phase 1
Start date	May 9, 2018
Completion date	December 18, 2019

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