PROCON (version 3.0)

• Research type

  Research Study

• Full title

  A trial of Prostate Radiotherapy in Conjunction with Carbogen and Nicotinamide (PROCON)

• IRAS ID

  57169

• Sponsor organisation

  East and North Hertfordshire NHS Trust

• Eudract number

  2010-021886-63

• ISRCTN Number

  N/A

• Research summary

  We propose to test whether it is possible to improve the outcome of prostate radiotherapy using simple, cost-effective measures. Carbogen gas (98% oxygen and 2% carbon dioxide) and nicotinamide (vitamin B3) will be given in conjunction with standard prostate radiotherapy. Disease control, survival and toxicity will be measured. In addition, we intend to monitor a group of these patients using oxygen sensitive magnetic resonance imaging. This will improve our understanding of the relationship between tumour oxygen levels, radiotherapy and outcome. The original prostate biopsy samples from each patient will also be analysed in the laboratory to see whether the response to these oxygen-enhancing methods can be predicted.Our group has recently demonstrated that the combination of breathing carbogen gas through a facemask for 10 minutes during radiotherapy treatment in conjunction with taking nicotinamide can significantly improve survival in bladder cancer (a 13% improvement compared to radiotherapy alone) without appreciably increasing side-effects. In another study we have also demonstrated that prostate cancer also responds to the oxygen-enhancing effects of carbogen gas. We therefore believe that it is important to test this schedule in prostate cancer. If proven to be successful, the fact that these measures cost little more than œ100 per patient will facilitate rapid and widespread adoption of the protocol. Furthermore, the versatility of the schedule means that combination with other technical advances in prostate radiotherapy (such as stereotactic radiosurgery or high-dose-rate brachytherapy) is easily achievable.

• REC name

  South Central - Oxford C Research Ethics Committee

• REC reference

  11/SC/0064

• Date of REC Opinion

  25 May 2011

• REC opinion

  Further Information Favourable Opinion