ICTM logo
STAMPEDE completes pilot phase successfully

03 April 2007

The STAMPEDE Trial Management Group are pleased to announce that the planned expansion of the trial is now starting.

STAMPEDE (Systemic Therapy in Advancing or Metastatic Prostate cancer: Evaluation of Drug Efficacy) now welcomes new centres to join in the trial. This follows successful recruitment to the Pilot Phase of the trial which has been conducted in a limited number of centres. The STAMPEDE Trial Management Group are pleased to announce that the planned expansion of the trial is now starting.

STAMPEDE is an international collaborative multi-centre 6-arm randomised controlled trial using multi-arm multi-stage (MAMS) methods. The aim is to assess the safety and effectiveness of novel approaches to the treatment of prostate cancer. The trial uses three drugs (docetaxel, zoledronic acid and celecoxib) in combinations with long-term hormone therapy.

Professor Nick James, STAMPEDE Chief Investigator, said "The trial combines traditional and innovative approaches and aims to investigate new treatments as first-line therapy in patients starting hormone therapy. At this point, patients would be fitter and better able to tolerate treatment than when their prostate cancer has become hormone refractory - earlier in the disease there is a possibility of having a larger and more durable effect."

The trial will recruit more than 3,000 new patients over the next 5 years. Some potential investigators may expect it to be difficult to recruit patients to a 6-arm trial. However, recruitment to the Pilot Phase has been very encouraging and patients and investigators have found the study design to be acceptable and practicable.

The trial is coordinated from the MRC Clinical Trials Unit in London, designed with the NCRI Prostate Clinical Studies Group and adopted by the National Cancer Research Network, Trial drugs are supplied free to participating centres. The EORTC will join recruitment in Summer 2007.

An Investigators Meeting for collaborators at new and existing trial centres will take place in London in April 2006. For more information about STAMPEDE and to begin the process of becoming an accredited centre please contact Karen Sanders at stampede@ctu.mrc.ac.uk or 020 7670 4831/44.