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

PHASE2CompletedINTERVENTIONAL
Enrollment

164

Participants

Timeline

Start Date

July 16, 2013

Primary Completion Date

April 20, 2015

Study Completion Date

June 5, 2018

Conditions
Prostate Cancer
Interventions
DRUG

Abiraterone Acetate

Type = exact number; unit = mg; number = 1000; form = tablet; route = oral; taken as four 250 mg tablets once daily at least 2 hours after eating and no food should be eaten for at least 1 hour after taking the tablets.

DRUG

Prednisone 5 mg twice daily

type = exact number; unit = mg; number = 5; form = tablet; route = oral; taken twice daily, the first dose in the morning after a meal and the second dose after a minimum interval of 8 hours in the late afternoon or early evening, after a meal

DRUG

Prednisone 5 mg once daily

type = exact number; unit = mg; number = 5; form = tablet; route = oral; taken once daily, in the morning after a meal

DRUG

Prednisone 2.5 mg twice daily

type = exact number; unit = mg; number = 2.5; form = tablet; route = oral; taken twice daily, the first dose in the morning after a meal and the second dose after a minimum interval of 8 hours in the late afternoon or early evening, after a meal

DRUG

Dexamethasone 0.5 mg once daily

type = exact number; unit = mg; number = 0.5; form = tablet; route = oral; taken once daily, in the morning after breakfast

Trial Locations (17)

Unknown

Aalst

Brussels

Ghent

Hasselt

Kortrijk

Leuven

Hanover

Mülheim

Nürtingen

Tübingen

Budapest

Miskolc

Birmingham

Glasgow

London

Sutton

Whitchurch

All Listed Sponsors
lead

Janssen Pharmaceutica N.V., Belgium

INDUSTRY

NCT01867710 - Abiraterone With Different Steroid Regimens for Side Effect Related to Mineralcorticoid Excess Prevention in Prostate Cancer Prior to Chemotherapy | Biotech Hunter | Biotech Hunter