GP Randomised Extended Action Triptorelin (GREAT study)- v1.0 11/01/12

• Research type

  Research Study

• Full title

  A PHASE IV, RANDOMISED, OPEN-LABEL, MULTI-CENTRE STUDY TO ASSESS THE IMPACT ON DISEASE CONTROL, SAFETY, PATIENT AND CLINICIAN EXPERIENCE OF CHANGING PATIENTS WITH ADVANCED PROSTATE CANCER FROM A 3-MONTHLY LHRH AGONIST TO 6-MONTHLY INJECTIONS OF DECAPEPTYL® SR 22.5MG

• IRAS ID

  99499

• Contact name

  Timothy Hall

• Sponsor organisation

  Ipsen Limited

• Eudract number

  2011-004213-16

• Research summary

  Prostate cancer is one of the most common cancers in men. One of the treatment options available is hormone therapy, in which drugs known as Luteinising Hormone-Releasing Hormone (LHRH) agonists are used to lower the level of the male hormone, testosterone, causing the cancer to regress. The use of a LHRH agonist is often called chemical castration because testosterone will drop to very low (castrate) levels. There are several LHRH agonists available on the market (Triptorelin/Decapeptyl, Goserelin/Zoladex, Leuprorelin/Prostap) which are mostly given as monthly or 3-monthly injections. Recently, a new formulation of Decapeptyl was launched in the UK as 6-monthly injections. This study will compare the new 6-monthly preparation of Decapeptyl with the standard 3-monthly LHRH agonists injections over a 12-month period on: - maintenance of castration (via regular blood testing of testosterone levels) - maintenance of stable Prostate Specific Antigen (PSA) (measurement of PSA levels is a blood test widely used in the diagnosis and monitoring of prostate cancer) - side effects - quality of life (a measure of how well a person is overall via completion of patient questionnaires) - patient satisfaction with treatment (via questionnaires) It is hoped that the study will demonstrate that 6-monthly injections of Decapeptyl are equivalent in terms of disease control and safety as the current 3-monthly LHRH agonists and that there is a definitive preference from both patients and physicians for 6-monthly injections. Stable prostate cancer patients treated with 3-monthly LHRH agonists will be randomly assigned to remain on their current treatment or to the new 6-monthly Decapeptyl formulation. This is an open-blind study meaning both the study doctors and the participants will know which treatment they are receiving. Participants will attend either 5 or 7 scheduled study visits. The study will be conducted in the UK at approximately 35-40 GP practices. 168 participants will be treated in the study.

• REC name

  South West - Central Bristol Research Ethics Committee

• REC reference

  12/SW/0096

• Date of REC Opinion

  1 May 2012

• REC opinion

  Further Information Favourable Opinion