NEPTUNE

• Research type

  Research Study

• Full title

  NEPTUNE: A Randomised Phase II Study of Neoadjuvant TAK-700 and Leuprorelin Acetate versus Surgery Alone in Intermediate and High Risk Clinically Localized Prostate Cancer

• IRAS ID

  99466

• Contact name

  Thomas Powels

• Sponsor organisation

  Queen Mary, University of London

• Eudract number

  2012-000478-42

• ISRCTN Number

  n/a

• Clinicaltrials.gov Identifier

  n/a

• Research summary

  Patients with prostate cancer confined to the prostate can be treated with surgery- also known as prostatectomy. The cancer can return despite this operation. This is particularly marked with patients with more aggressive disease. These patients are known to have intermediate and high risk localized prostate cancer. The goal of this research project is to try to reduce the risk of the cancer returning by giving a period of new hormone based therapy prior to the prostatectomy. Currently patients with intermediate and high risk localized prostate cancer are usually treated with surgical removal of the prostate (prostatectomy). Prostatectomy has become a standard operation for these patients, although other types of surgery (laparoscopic or open) are also used. However even with this surgery they have a 30-40% chance of the developing of recurrent disease after treatment. Patients with recurrent disease have a poor outcome and usually die from their disease. Treatment for recurrent disease includes hormone therapy, chemotherapy and bone targeted therapy and is associated with significant mortality. The study investigates giving a new drug called orteronel (TAK-700) in combination with leuprorelin acetate to patients with high and intermediate risk prostate cancer for up to six months prior to a prostatectomy (surgery). To determine if this approach is effective we will compare the outcome of patients who have the combined approach of hormone therapy and prostatectomy compared with standard therapy which is prostatectomy alone. Patients will be randomised into one of these 2 treatment options. Orteronel and leuprorelin acetate are the hormone drugs being used in this study. Both reduce testosterone levels which are a male hormone and helps prostate cancer grow. Orteronel is a new treatment which is currently under development. It looks particularly effective at treating prostate cancer in patients with more advanced disease. It is given with leuprorelin as standard. We hope that by giving these agents before the surgery we can reduce the tumour size, improve surgical outcomes and decrease relapse rates. If this study is positive it would lead to larger studies which may change the way we treat early prostate cancer.

• REC name

  London - City & East Research Ethics Committee

• REC reference

  12/LO/1653

• Date of REC Opinion

  8 Jan 2013

• REC opinion

  Further Information Favourable Opinion