A6181120 Sunitinib and Prednisone Treatment in Prostate Cancer

• Research type

  Research Study

• Full title

  A MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PHASE 3 STUDY OF SUNITINIB PLUS PREDNISONE VERSUS PREDNISONE IN PATIENTS WITH PROGRESSIVE METASTATIC HORMONE-REFRACTORY PROSTATE CANCER AFTER FAILURE OF A DOCETAXEL-BASED CHEMOTHERAPY REGIMEN

• Sponsor organisation

  Pfizer Ltd

• Eudract number

  2008-002158-40

• ISRCTN Number

  N/A

• Clinicaltrials.gov Identifier

  NCT00676650

• Research summary

  Sunitinib is a drug which acts on cancer cell proteins called receptor tyrosine kinases (RTK). Research shows that some cancer cells produce significant amounts of some of these RTKs, which can lead to increased blood supply to cancer cells and cancer growth. Sunitinib works to block some of these RTK proteins and might affect tumour growth as a result. Prednisolone is an anti-inflammatory agent sometimes used in combination with cancer drugs in men with prostate cancer which does not respond to hormone treatment and has spread to other parts of the body such as the bones. Studies suggest that prednisolone can relieve bone pain associated with this type of cancer. Purpose: This study will compare the effects of sunitinib plus prednisolone with placebo (jnactive drug) plus prednisolone in men with prostate cancer which does not respond to hormone treatment and has spread to other parts of the body after having received chemotherapy with a drug called docetaxel. Treatment: People taking part in the study will receive either sunitinib plus prednisolone or placebo plus prednisolone. A computer will randomly (liking tossing a coin) assign study participants to their treatment group. Sunitinib (or placebo) will be taken orally once daily by study participants. Prednisolone will be taken orally twice daily. Several tests and exams will be given throughout the study to monitor participants closely. Treatments will be stopped if a participantÇs cancer gets worse or has unacceptable side effects. This study is being funded by Pfizer Ltd. A total of approximately 819 patients will be included around the world, at as many as 160 sites in 22 countries.

• REC name

  West of Scotland REC 1

• REC reference

  08/S0703/112

• Date of REC Opinion

  7 Oct 2008

• REC opinion

  Further Information Favourable Opinion