COU-AA-302 Abiraterone Acetate in Metastatic Prostate Cancer April-09
Research type
Research Study
Full title
A Phase 3, Randomized, Double-blind, Placebo-Controlled Study of Abiraterone Acetate (CB7630) Plus Prednisone in Asymptomatic or Mildly Symptomatic Patients with Metastatic Castration-Resistant Prostate Cancer
IRAS ID
21952
Contact name
Johann S de Bono
Sponsor organisation
Cougar Biotechnology
Eudract number
2008-008004-41
ISRCTN Number
N/A
Clinicaltrials.gov Identifier
Research summary
In patients with prostate cancer that has progressed despite initial hormonal therapy, the body's still producing very low levels of testosterone in the adrenal glands, and the tumour itself may be producing testosterone locally. These levels of testosterone may be stimulating tumour growth. The purpose of this study is to compare the effects of a new treatment for advanced prostate cancer, abiraterone acetate, with common second-line hormonal treatment in men whose tumours have failed first-line hormonal treatment. Abiraterone acetate is a drug in the steroid class that blocks the activities of two enzymes that'ssist in the production of testosterone in the testis, adrenal glands and tumours. The drug has been studied so far in about 1000 patients that have received the selected dose of 1000mg daily. In early phase studies, this dose of abiraterone acetate seemed to reduce the PSA levels of a number of patients. Some of these patients also needed less medication for pain and saw improvements in various other imaging studies as well. The current phase 3 study will compare the clinical benefit of abiraterone acetate plus prednisolone with placebo plus prednisolone in asymptomatic or mildly symptomatic patients with metastatic castration-resistant prostate cancer (CRPC). Prednisolone is a common second-line hormonal therapy for patients with CRPC and also lessens the toxicity of abiraterone acetate. The primary outcomes to be determined will be patient survival and time to which the disease progresses. Safety assessments will also be performed on a regular basis including haematology, biochemistry, cardiac assessments and adverse event assessment. Patient visits will occur every two weeks for the first three months and then monthly while the patient is on study treatment. Patients who have had prior prostate cancer treatment with chemotherapy, biologic therapy, or ketoconazole are not eligible for this trial. This study is a global trial sponsored by Cougar Biotechnology and will involve ten or more sites in the UK. The treatment phase of the study will take approximately 6 months to 2 years; the follow-up phase will take 5 years.
REC name
London - Fulham Research Ethics Committee
REC reference
09/H0711/56
Date of REC Opinion
25 Jun 2009
REC opinion
Favourable Opinion