New Radiotherapy comparison arm

As recently announced, the STAMPEDE TMG have discussed the introduction of a new research arm to assess local radiotherapy to the prostate for men with metastatic disease and a funding application is now being prepared for a submission to Cancer Research UK in April 2012.

Here is a link to a 5-question survey which we would like you to complete by Friday 13^th of April to confirm the acceptability of the proposal.

It will take only 3 minutes to complete, but it will be essential to maximise the success of the trial. Please feel free to forward this link to anyone at your centre, who you think might be instrumental for the implementation of this new arm (i.e. Radiotherapy Clinical Lead).

Below you will also find further information on the results from the previous survey and details on the proposed new comparison arm.

In the following weeks, a few open Q&A sessions will be held via teleconference with the clinical lead for this new comparison, Dr Chris Parker, to address any questions you and your team might have about this new comparison arm.

Many thanks for your continued support and enthusiasm for the STAMPEDE trial.

Further information:

Summary results Questionnaire 1

Summary RT comparison arm proposal

Innovative trial finds celecoxib does not improve prostate cancer outcomes

Results published today (27/03/2012) in The Lancet Oncology show that adding the drug celecoxib to standard hormone therapy does not improve outcomes for men with prostate cancer.

These results are from the STAMPEDE trial, which is testing several promising new approaches to see if they can prevent the re-growth of prostate cancer tumours. A pre-planned intermediate analysis showed that the addition of celecoxib to hormone therapy did not result in enough benefit to justify continuing to recruit further patients to the comparison. Recruitment of patients to the celecoxib arms of the trial was halted and treatment with the drug was also stopped. Researchers will continue to follow up patients who received celecoxib, to monitor the long-term effects and whether any benefit does emerge. Further information about these results is available in a short policy brief.

While these results are disappointing, the design of the trial means that it focuses its efforts on other more promising new drugs. STAMPEDE uses an innovative “multi-arm multi-stage” (or “MAMS”) design. This allows it to compare several different treatment approaches to a single control group. Treatments that are not active enough can be stopped early, while recruitment continues throughout to more promising arms. Furthermore, investigators can investigate other new treatments as the trial goes on. The trial recently added a new arm, testing abiraterone. Abiraterone can help patients whose prostate cancer has stopped responding to standard hormone therapy. STAMPEDE will look at whether it can also benefit men whose tumours are responding to hormone therapy.

The STAMPEDE trial started in 2005, and currently has nearly 3,000 patients taking part. It is taking place in more than 100 hospitals, mainly in the UK. The MRC CTU runs STAMPEDE, and Cancer Research UK funds it, along with Janssen, Novartis, Sanofi-Aventis and Pfizer. The trial registration number is NCT00268476.

Further Information

• Study Page
• Policy brief about the STAMPEDE celecoxib results
• Lancet Oncology article about the STAMPEDE celecoxib results
• Lancet Oncology editorial about these results

Record Recruitment Day

STAMPEDE has broken its record for number of patients randomised to the trial in one day! The previous record had been 9, but on Wednesday 22nd February this was surpassed with 12 patients being randomised.

This brought our total patients in the trial to 2889!

STAMPEDE at the GU ASCO conference

STAMPEDE had a good presence at the recent 2012 Genitourinary Cancers Symposium in San Francisco where our Chief Investigator, Professor Nick James, presented posters for two STAMPEDE abstracts. We are pleased to say that the paper which reports the results of the celecoxib comparison has been accepted for publication by The Lancet Oncology. We hope that our second practical methodology paper will be submitted soon. In the meantime please take a look at the GU ASCO abstracts for each paper here: http://bit.ly/xIDtbF

 New Abiraterone Arm  launched on Tuesday 15^th November

Following recent communication, you will be aware that the STAMPEDE trial protocol has recently undergone a substantial amendment, primarily to incorporate a new trial arm, Arm G = Hormone Therapy + Abiraterone. We are pleased to announce that we went live with the new 5-arm design on Tuesday 15th November and the Beatson Cancer Centre was the first to draw arm G when randomising a patient! 

The latest version of the protocol is version 8.0 2^nd Sep 2011. Please click on the links below to access the following documents:

STAMPEDE protocol version 8.0 

STAMPEDE protocol appendices version 8.0 

Version 8.0 approval letters from MHRA^* and the main REC

Separated Word versions of the updated PIS, consent form and GP letter

Please contact the MRC CTU for the Annex 2 Notification of amendment form

From this point Tuesday 15th November, only centres that have received and submitted to the MRC CTU R&D approval for version 8.0 of the trial will be able to participate and therefore it is really important that all centres look to process this amendment as soon as possible, if not completed already.

Please do not hesitate to contact us at the MRC CTU if you require any further information.

MRC Clinical Trials Unit, Aviation House, 125 Kingsway, London, WC2B 6NH

                                                                       stampede@ctu.mrc.ac.uk