Dasatinib & Docetaxel vs. Docetaxel in Advanced Prostate Cancer v. 1

• Research type

  Research Study

• Full title

  A Randomised Double-Blind Phase 3 Trial Comparing Docetaxel Combined with Dasatinib to Docetaxel Combined with Placebo in Castration-Resistant Prostate Cancer

• IRAS ID

  5237

• Sponsor organisation

  Bristol-Myers Squibb International Corporation

• Eudract number

  2008-000701-11

• ISRCTN Number

  N/A

• Clinicaltrials.gov Identifier

  NCT00744497

• Research summary

  Prostate cancer is one of the most common cancers in men in the UK. In many patients with advanced prostate cancer, the cancer can spread to the bone (called bone metastases) causing severe symptoms. Standard drug treatment for these patients is with the drugs docetaxel and prednisone/prednisolone. The purpose of this study is to see if adding the study drug, dasatinib, to standard treatment will prolong survival of patients, and help to reduce pain and other symptoms caused by their bone metastases. Of the 1,380 patients to be enrolled worldwide, half will receive docetaxel, prednisone and dasatinib and the other half docetaxel, prednisone and placebo. UK recruitment starts in January, 2009 and ends in October, 2010. The study is funded by Bristol-Myers Squibb, and is being carried out in Colchester, Cardiff, London, Leeds, Bristol and Edinburgh.Patients who consent to participating in the study will undergo:1. Screening: physical examination, heart function tests, blood and urine tests, measurement of the prostate cancer and metastases by scans, and completion of two pain questionnaires.2. Randomisation: randomised to receive standard treatment plus either dasatinib or placebo. It will not be known which treatment patients will receive. [This study design is called Ó?double-blind?.] 3. Treatment until the patient??s disease worsens or progresses or they experience unacceptable side effects. 4. End of Treatment: physical examination, blood and urine tests, scans and completion of the questionnaires.5. Follow-Up: where possible, patients will be seen every four weeks if they were experiencing side effects when they stopped treatment, or every 12 weeks if no side effects but their disease has not progressed. Also where possible, the patient or a family member will then be contacted by the study doctor or nurse every three months to check on the patient??s status.

• REC name

  East of England - Essex Research Ethics Committee

• REC reference

  08/H0301/127

• Date of REC Opinion

  31 Dec 2008

• REC opinion

  Further Information Favourable Opinion