Welcome!

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Welcome to the STAMPEDE website. We will be adding regular updates about the trial and have made all of the trial documentation available for you to download. Please check the site regularly and add us to your favourites!

About STAMPEDE

Prostate cancer accounts for around one fifth of all male cancers. In the UK there are around 25,000 new cases each year and around 10,000 deaths.  Most men with prostate cancer are given hormone therapy and this is often effective for a short time at stopping the tumour growing. However in most cases over time the tumour will start to grow again.

The aim of this trial is to try to prevent the tumour re-growth by adding other treatment to the hormone therapy. The trial is currently assessing abiraterone and enzalutamide in combination with hormone therapy or radiotherapy (newly diagnosed metastatic patients only) in combination with hormone therapy.


 
 

New CRF completion guidelines

Please read our new CRF completion guidelines to help keep data queries to a minimum.   

 

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Arm J opens!

Arm J opened to recruitment on 29th July 2014. It is assessing the addition of abiraterone and enzalutamide to standard care. Please find links to the updated protocol, CRFs, patient related documents, approvals and pharmacy documents below:

 

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STAMPEDE editorial published

We are pleased to inform you that the editorial on the "enzalutamide and abiraterone comparison" submitted to European Urology has been accepted and it’s now available open access.

You can view it via the link here.

 

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STAMPEDE: update on recent data

Recent publications and presentations of RCTs of zoledronic acid and docetaxel have been discussed by the STAMPEDE Trial Management Group, in light of the recent review of data by the trial's Independent Data Monitoring Committee and a meeting of the Trial Steering Committee.

The STAMPEDE TMG has issued a statement which can be viewed here.   

 

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Investigator meetings 2014

Four STAMPEDE investigator meetings were recently held around the UK in Cardiff, Edinburgh, Manchester and London to discuss the new trial arm: enzalutamide and abiraterone in combination with hormone therapy. Presentations were given by members of the STAMPEDE trial management group and representatives from Astellas and Janssen.

Thank you to all who attended and contributed! 

The presentation slides can be found here.

 

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Major recruitment milestone in STAMPEDE

Recruitment to the “abiraterone comparison” of STAMPEDE was completed on 17 January 2014, after the recruitment target was reached. This is a major milestone for the trial because the “abiraterone comparison” was the first of the new comparisons to be incorporated into this ongoing multi-arm multi-stage trial. Most trials have only two arms and do not change. STAMPEDE started with 6 arms, and has efficiently drawn in further comparisons over time.

Rates of accrual to STAMPEDE were remarkable throughout 2013 with an average of around 150 patients per month. The recruitment target for the “abiraterone comparison” of 1800 men with hormone-naïve prostate cancer was reached in 26 months instead of the predicted 36 months.

The “abiraterone comparison” compares men randomised over the same period of time to either the control group (Arm A: standard care with androgen deprivation therapy with or without radiotherapy) or the abiraterone group (Arm G: standard care plus abiraterone and prednisone).

Recruitment to the abiraterone group started 5 years after the trial originally opened, but has been completed only 10 months after completion of recruitment to the original research arms. The original research arms assessed adding one or two of zoledronic acid, docetaxel or celecoxib to standard care.

The primary outcome measure for all comparisons is overall survival. Follow-up activity continues for all trial patients. The results of the different comparisons within STAMPEDE are eagerly awaited.

Recruitment to the trial continues to the “M1/RT comparison” which looks at radiotherapy-to-the-prostate in men whose disease has already spread elsewhere. This was the second new comparison, initiated in January 2013. A third new comparison, the “enzalutamide + abiraterone comparison”, should start recruitment in March with the initiation of Arm J. More information will follow.

More than 5,000 patients from across the UK and Switzerland have joined STAMPEDE, demonstrating  the feasibility and benefits of conducting new comparisons within an ongoing trial.

The STAMPEDE team would like to thank all of the site staff and patients involved in the trial.

 

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Protocol version 11 released

Protocol version 11 is now available to all participating centres and can be found in the protocol and appendices section. Ethics and MHRA approval letters and a new site file assessment form can be found in essential documents. The protocol has been amended to reflect the increase in target sample size for the “abiraterone comparison” from 1,500 to 1,800 patients.

 

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Summer Newsletter

For the latest STAMPEDE news and updates, please take a look at our summer newsletter here.

 

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STAMPEDE at ASCO 2013

STAMPEDE TMG members Professor Nick James and Professor Noel Clarke recently took off to Chicago to the American Society of Clinical Oncology (ASCO) annual meeting to present a poster looking at the prognosis of metastatic patients within the trial’s control arm. With the large amount of data STAMPEDE collects on newly diagnosed metastatic prostate cancer patients receiving androgen deprivation therapy (ADT) alone, this presented a great opportunity to look at such a specific population, for whom there is limited information.

The poster can be viewed here.

A link to the abstract can be found here. A detailed analyses of this data will be submitted for publication soon.

 

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Please click here to view our past updates

 

.About prostate cancer

.About randomisation

.Trial summary

.Protocol and appendices

.CRFs

.MRC CTU contacts