Effect of Decapeptyl on Prostate Volume Pre Radiotherapy (EDVART)

• Research type

  Research Study

• Full title

  A Randomised Controlled Trial to Determine the Effect of Decapeptyl on Reduction of Prostate Volume Pre-Radiotherapy Compared with Standard Therapy (Zoladex)

• IRAS ID

  34733

• Contact name

  Amit Bahl

• Sponsor organisation

  University Hospitals Bristol NHS Foundation Trust

• Eudract number

  2008-007028-25

• ISRCTN Number

  to be applied for

• Research summary

  Radical radiotherapy is used as a curative treatment in men with prostate cancer. The current National Institute for Health and Clinical Excellence guidance on prostate cancer management supports the use of hormone injections for three to six months before radical radiotherapy. The use of hormones before radiotherapy aims to reduce the size of the prostate gland so that the area to be treated with radiotherapy is smaller, therefore reducing the risk of damage to normal tissue near the prostate. It has been shown that using a hormone injection called Zoladex in this way for three months reduces the prostate size significantly and offers improved survival. This study aims to find out whether Decapeptyl, a similar hormone injection commonly used in prostate cancer, is as effective as Zoladex in reducing prostate size before radical radiotherapy. Decapeptyl and Zoladex both belong to the same group of hormone drugs called Luteinising Hormone Releasing Hormone analogues which work by reducing testosterone levels in the body. The use of Decapeptyl before radiotherapy would involve a significant financial benefit to the NHS.This is a randomized controlled trial. Patients will be chosen at random to receive either Decapeptyl or Zoladex injections and will take part in the study for a period of 14 weeks before their radiotherapy treatment. 72 patients will be recruited from University Hospitals Bristol NHS Foundation Trust and North Bristol NHS Trust; all patient visits will take place at University Hospitals Bristol NHS Foundation Trust. Each patient will have five study visits during which hormone injections will be given, questionnaires administered and blood tests taken. Prostate size will be measured by ultrasound before and after the three months of hormone treatment.The study is sponsored by the University Hospitals Bristol NHS Foundation Trust and is funded by a grant from Ipsen Ltd.

• REC name

  South Central - Oxford C Research Ethics Committee

• REC reference

  10/H0606/43

• Date of REC Opinion

  13 Aug 2010

• REC opinion

  Favourable Opinion