A number of newer treatments have become available and have shown initial promise against prostate cancer. Newer treatments are usually used in prostate cancer when hormone treatment is no longer effective and the cancer has started to grow again. An alternative approach would be to investigate the use of experimental agents at an earlier stage, at the time of initiating long term hormone therapy; patients would be fitter, may be better able to tolerate them and there is the possibility of having a larger effect.

Objectives

STAMPEDE is designed to assess the safety and efficacy of 3 very different drugs for the treatment of locally advanced or metastatic prostate cancer. These drugs are docetaxel (chemotherapy), zoledronic acid (bisphosphonate) and celecoxib (cox-2-inhibitor) and are given in various combinations to patients starting long-term hormone therapy.

The trial is divided into five phases � Pilot and Efficacy Stages 1-3 and Efficacy Stage 4. The primary outcome measures are safety + feasibility, failure-free survival and overall survival, respectively.

Trial Status

The STAMPEDE trial had an initial Pilot Phase to assess feasibility during which a selection of centres were invited to participate.  The Pilot Phase was completed ahead of schedule in March 2007, the trial is now into the first efficacy stage and participation has been widened to include all interested centres.

Patient Information

Study Investigators/Health Care Professionals Information

For general enquiries about the trial or website please e-mail stampede@ctu.mrc.ac.uk