Overview

Abiraterone With Different Steroid Regimens for Side Effect Related to Mineralcorticoid Excess Prevention in Prostate Cancer Prior to Chemotherapy

Status:
Completed

Trial end date:
2018-06-05

Target enrollment:

Participant gender:

Summary

The purpose of the study is to determine the safety and clinical benefit of the combinations of abiraterone acetate and prednisone or abiraterone and dexamethasone in prostate cancer patients. Prednisone will be given at one of three different dose schedules. Dexamethasone will be given at one dose schedule. This will include looking at what side effects occur and how often they occur. In addition the impact of the study drug on quality of life and pain will be evaluated. The study will also collect data on subsequent treatment of patients after they come off the study drug (approximately 4.5 years after the start of study treatment of the first subject participating in the study). By analyzing blood samples, the study aims to identify if some markers could help to understand if the treatment with abiraterone is effective and also help to understand if patients can become resistant.

Phase:

Phase 2

Details

Lead Sponsor:

Janssen Pharmaceutica N.V., Belgium

Treatments:

Abiraterone Acetate
BB 1101
Dexamethasone
Dexamethasone 21-phosphate
Dexamethasone acetate
Mineralocorticoids
Prednisone