A Multi-Centre, Randomised, Double Blind. Placebo Controlled Trial to Investigate the Effect of Bicalutamide (Casodex) 150mg on the Pharmacokinetics of Midazolam in Prostate Cancer Patients

INTERVENTION: Patients are randomised to receive: 1. Treatment A: Bicalutamide 150 mg daily for 35 days plus three oral doses of midazolam 7.5 mg on days 1, 10 and 35. 2. Treatment B: Oral placebo daily for 35 days plus three oral doses of midazolam 7.5 mg on days 1, 10 and 35. NB Active treatment Bicalutamide or placebo was only taken for 28 days (Day 8‐35). CONDITION: Prostate cancer ; Cancer ; Prostate PRIMARY OUTCOME: Not provided at time of registration SECONDARY OUTCOME: Not provided at time of registration INCLUSION CRITERIA: 1. Histologically or cytologically confirmed prostate cancer 2. If surgically orchiectomised following 1 month depot of leutenizing hormone releasing hormone (LHRH) analogue therapy, at least 42 days must elapse from the end of the therapy before entry into the trial. 3. Adequate liver function 4. Not currently receiving drugs which may effect treatment