Study of ARN-509 in Prostate Cancer
Research type
Research Study
Full title
A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase III Study of ARN-509 in Men with Non-Metastatic (M0) Castration-Resistant Prostate Cancer
IRAS ID
124209
Contact name
Simon Chowdhury
Contact email
Sponsor organisation
Aragon Pharmaceuticals
Eudract number
2012-004322-24
Duration of Study in the UK
4 years, 11 months, 28 days
Research summary
The present study is a multicentre, randomised, double-blind, placebo controlled study of ARN-509 in men with non-metastatic, castration-resistant prostate cancer.(NM-CRPC)
Prostate cancer is the second most frequently diagnosed cancer and the sixth leading cause of cancer death in males. Men with high risk NM-CRPC are at significant risk for development of metastases and prostate cancer-specific death. To date there are no approved treatments or standard of care for men with high risk NM-CRPC and thus this patient population represents an area of unmet medical need.ARN-509 is a new generation androgen receptor (AR) antagonist that has been developed to overcome the potential therapeutic deficiencies of first generation AR antagonists. ARN-509 is orally available and acts by inhibiting the action of androgen.
Patients will be randomised 2:1 onto either ARN-509 or placebo, and will be followed for safety and efficacy and will remain on study treatment until documented radiographic progression or the development of unacceptable toxicity.The study will be carried out at approximately 250 hospitals with approximately 1,200 patients that will be invited to participate. Doctors in Oncology Departments of NHS hospitals will be treating participants in the UK.
Study accrual is expected to last for up to 24 months per patient, with a minimum follow up period of 10 months. Total study duration per patient is expected to be approximately 6 months.
REC name
London - Fulham Research Ethics Committee
REC reference
13/LO/1277
Date of REC Opinion
23 Sep 2013
REC opinion
Favourable Opinion