degarelix vs goserelin on prostate size reduction in prostate cancer

• Research type

  Research Study

• Full title

  A randomised, parallel arm, open-label trial comparing degarelix with goserelin plus anti-androgen flare protection (bicalutamide), in terms of prostate size reduction in prostate cancer patients of intermediate-to-high risk, who require neoadjuvant hormone therapy prior to radiotherapy (curative intent)

• IRAS ID

  8358

• Contact name

  Malcolm Mason

• Sponsor organisation

  Ferring Pharmaceuticals A/S

• Eudract number

  2008-005232-33

• ISRCTN Number

  0000000000000

• Clinicaltrials.gov Identifier

  0000000000000

• Research summary

  Prostate cancer is a common disease in males. The risk of getting prostate cancer increases with age. Depending upon the size or spread of the tumour, prostate cancer may be treated by surgery, radiotherapy, or drugs. In most prostate cancers, the growth of cancer cells is stimulated by a hormone called testosterone. Reduction of testosterone can help to reduce cancer growth and spread.Some patients receive radiation treatment for prostate cancer, and the doctors treating them would like to shrink the size of the prostate gland before the radiation treatment in order to increase the safety and efficiency of the procedure. There are several treatments available that can decrease the size of the prostate gland when it is enlarged due to cancer. The purpose of this trial is to look at how well a new trial, prostate-shrinking drug works and how safe it is, compared to a standard prostate-shrinking treatment for prostate cancer. The new trial drug is called degarelix. Degarelix causes testosterone in the blood to quickly fall to very low levels.The comparator treatment is Zoladex, also known as goserelin. This drug also reduces testosterone levels. It is a very widely used and standard prostate-shrinking treatment in this situation. However, it works differently from degarelix and it requires pre-treatment with another approved drug, Casodex (also known as bicalutamide). The two drugs are given together because given alone the first drug may cause a testosterone surge at the start of treatment, and may stimulate tumour growth.The trial lasts for three months and patients have to attend the clinic five to six times. Between the visits they can go on with daily life as normal. They will be assigned completely randomly to one of the two treatments; both are given as injections just under the skin on the stomach.

• REC name

  Wales REC 3

• REC reference

  08/MRE09/69

• Date of REC Opinion

  7 Jan 2009

• REC opinion

  Further Information Favourable Opinion