212082PCR3011
Research type
Research Study
Full title
A Randomized, Double-blind, Comparative Study of Abiraterone Acetate Plus Low-dose Prednisone Plus Androgen Deprivation Therapy (ADT) Versus ADT Alone in Newly Diagnosed Subjects With High-Risk, Metastatic Hormone-Naive Prostate Cancer (mHNPC)
IRAS ID
116833
Contact name
Andrew Protheroe
Contact email
Sponsor organisation
Janssen-Cilag International NV
Eudract number
2012-002940-26
Clinicaltrials.gov Identifier
Research summary
Abiraterone Acetate (also referred to as JNJ212082)is an irreversible inhibitor of CYP17, a key enzyme required for testosterone synthesis. This enzyme is found in the testes, adrenals, and prostate tumours. Prostate cancer is the most common noncutaneous cancer among men in Europe. It is an androgen dependent disease and inhibition of testosterone is a key element in the control of prostate tumour growth. Abiraterone Acetate in combination with prednisone has been approved (marketed name ZYTIGA) for the treatment of men with mCRPC who have received prior chemotherapy containing docetaxel. More recently, in December 2012 approval was given by the EMA of Abiraterone acetate in the treatment of metastatic castration resistant prostate cancer in adult men who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy in whom chemotherapy is not yet clinically indicated.
The study will consist of a screening period followed by treatment cycles of 28 days where patients will be randomly allocated to receive either 1000 mg daily Abiraterone Acetate, low dose prednisolone (25mg daily) and Androgen Deprivation Therapy (ADT), (LHRH agonists) or the control group (ADT plus placebos). The study is double blinded so that the patient and the Investigator does not know what the patient is receiving. The patients will continue until they are no longer receiving benefit or the Sponsor terminates the study. Once the patient has discontinued and end of treatment visit will be performed within 30 days after the last dose and patients will then be followed up every 4 months for 60 months. In the event of a positive study result, all subjects will have the opportunity to enroll in an Open-label Extension Phase.
REC name
South Central - Oxford C Research Ethics Committee
REC reference
13/SC/0184
Date of REC Opinion
24 May 2013
REC opinion
Further Information Favourable Opinion