CANCAP01

• Research type

  Research Study

• Full title

  Neoadjuvant docetaxel prior to radical prostatectomy for high risk localised prostate cancer. Evaluation of biological and functional imaging surrogates of therapy efficacy.

• IRAS ID

  21260

• Sponsor organisation

  Cambridge University Hospitals NHS Trust

• Eudract number

  2009-014491-21

• ISRCTN Number

  n/a

• Clinicaltrials.gov Identifier

  n/a

• Research summary

  Neoadjuvant taxane chemotherapy may improve the clinical outcome of men with high risk disease treated by radical prostatectomy. The first consideration however is if the drug is reaching the target and having an effect on prostate tumours. Early mid point surrogates of response may further select men who will have a good outcome from chemotherapy. In this study our goal is to pilot the use of docetaxel as a neoadjuvant therapy in high risk prostate cancer. Central to this is the development of effective surrogates of treatment response which can be assayed during treatment and prior to surgery. This study will be the basis for a future larger Phase II/III trial of neoadjuvant docetaxel prior to radical prostatectomy in high risk localised prostate cancer.

• REC name

  East of England - Cambridge Central Research Ethics Committee

• REC reference

  09/H0308/161

• Date of REC Opinion

  19 Oct 2009

• REC opinion

  Further Information Favourable Opinion