Comparison of degarelix and goserelin 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 reduction in International Prostate Symptom Score (IPSS), in patients with lower urinary tract symptoms (LUTS) secondary to locally advanced prostate cancer

• IRAS ID

  6648

• Contact name

  John Anderson

• Sponsor organisation

  Ferring Pharmaceuticals A/S

• Eudract number

  2008-004338-26

• ISRCTN Number

  n/a

• Research summary

  Prostate cancer is a common disease. Depending upon the size or spread of the tumour, it may be treated by surgery, radiotherapy, or drugs. In the early stage, when the tumour is only present in the prostate itself, treatment includes radical surgery and / or radiotherapy. In patients with low-stage disease, medical or surgical intervention may also be deferred and a policy of active surveillance may be adopted (watch and wait). In advanced prostate cancer (defined as tumour growth beyond the organ, which means that other body systems are affected) androgen suppression (suppression of male sex hormones) has in these cases become one of the most commonly used procedures, aimed at slowing disease progression. In many prostate cancers, growth of cancer cells is stimulated by a hormone called testosterone. Reduction of testosterone can help to reduce cancer growth and spread. The new trial drug is called degarelix, is a blocker of a hormone called gonadotrophin-releasing hormone (GnRH). Degarelix causes testosterone in the blood to fall to very low levels. The comparator treatment is Zoladex, also known as goserelin. This drug also inhibits GnRH and reduces testosterone levels. 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

  Yorkshire & The Humber - Leeds East Research Ethics Committee

• REC reference

  08/H1306/158

• Date of REC Opinion

  15 Dec 2008

• REC opinion

  Further Information Favourable Opinion