MDV3100 for chemotherapy-naïve patients with prostate cancer

• Research type

  Research Study

• Full title

  PREVAIL: A Multinational Phase 3, Randomized, Double-Blind, Placebo Controlled Efficacy and Safety Study of Oral MDV3100 in Chemotherapy-Naïve Patients with Progressive Metastatic Prostate Cancer Who Have Failed Androgen Deprivation Therapy

• IRAS ID

  60505

• Contact name

  J De-Bono

• Sponsor organisation

  Medivation, Inc

• Eudract number

  2010-020821-41

• ISRCTN Number

  n/a

• Research summary

  Prostate cancer growth depends on substances called androgens. Anti-androgen medications are often used in the treatment of prostate cancer. Investigations have shown that advanced tumours have an increased number of androgen receptors and these tumours become resistant to currently available anti-androgen treatments. It is thought that newer therapies that are strong blockers of these receptors may be effective in patients with advanced prostate cancer. The purpose of this study is to determine the benefit of MDV3100, a new compound that is a strong blocker of the androgen receptor.This study, called PREVAIL, will enroll patients with metastatic prostate cancer that have no or mild pain from prostate cancer and have progressed despite their current treatment. Eligible participants will be assigned randomly to receive either MDV3100 or placebo (a dummy treatment containing no active ingredient). Both are given by mouth daily until disease progression is confirmed and they have changes in their anti-tumour treatment regimen. Participants will be required to attend the clinic every four weeks until Week 25 and then every 12 weeks subsequently. A safety follow up visit will be performed 28 days after the last dose and participants will be contacted for long-term follow-up according to the schedule (every four weeks until Week 49 and then every 12 weeks thereafter). During clinic visits, assessments will be performed including vital signs, physical examination, blood samples, examination of the heart using an electrocardiogram, and a CT/MRI and bone scan. Participants will be asked to complete questionnaires about pain, fatigue and quality of life at certain visits.This study is sponsored by Medivation, Inc. Approximately 150 patients from 15 centres in the UK are expected to enroll in this global study.

• REC name

  London - Harrow Research Ethics Committee

• REC reference

  10/H0715/57

• Date of REC Opinion

  12 Nov 2010

• REC opinion

  Further Information Favourable Opinion