News

Additional Safety Assessments - Reminder of requirement for monthly LFTs monitoring for all patients receiving abiraterone (Arms G & J)


Please ensure that all patients taking abiraterone as part of their research treatment have the required additional safety monitoring as outlined in the STAMPEDE protocol.

Here is a link to the schedule of investigations for current comparisons.


Launch of PSA Progression Value Calculator

For the purposes of the STAMPEDE trial, a PSA progression value calculator has been created to allow sites to calculate a unique threshold PSA value for biochemical failure for each patient, referred to as the PSA progression value. In the past, research staff have received Progression Letters or contacted the STAMPEDE trial team to obtain this value. However the PSA progression calculator allows research staff to determine the Progression Value themselves, by entering the patient’s PSA results from randomisation to week 24, and printing a copy of the calculation for the patient’s records.

We hope with the launch of this calculator it will be easier for you to track a patient’s PSA record and progression status. Additionally we welcome any feedback or suggestions for improvement!


For more details click here.



Results from the "Celecoxib Comparisons"

We are pleased to inform you of the survival results from the oncology “celecoxib comparisons” have now been published in The Journal of Clinical Oncology. A link to the Open Access paper is provided here for your information, along with an editorial relating to the results:

The Journal of Clinical Oncology paper

Open Access paper: http://ascopubs.org/doi/abs/10.1200/jco.2016.69.0677

Editorial: http://ascopubs.org/doi/full/10.1200/JCO.2017.72.2793



Recruitment to Arm J Closes On the 31st March 2016

The “enzalutamide +abiraterone comparison” has progressed through its first intermediate analysis and the second intermediate analysis is planned for March 2016. Thanks to the amazing enthusiasm and support by all participating centres, we are now fast approaching the recruitment target of approximately 1,800 patients. Current accrual rates and projections indicate that the target will be reached by the end of Q1-2016. 

For this reason, all randomisations to Arm J will stop on Thursday 31-Mar-2016 at 5pm.

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 forth new comparison, the “metformin comparison”, should start recruitment in April with the initiation of Arm K. More information will follow.

More than 7,900 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.

STAMPEDE at ESMO 2014

The STAMPEDE TMG member Dr Chris Parker presented at the European Society for Medical Oncology congress held in Madrid on 26th to 30th September 2014. The talk was focused on the role of radiotherapy on failure-free survival in newly-diagnosed M0 patients from the STAMPEDE control arm. The results strongly support the use of RT in N+ patients and they are similar to the effect seen in the N0 population.
 
A copy of the presentation can be found here and a manuscript will be soon submitted for publication on behalf of the STAMPEDE investigators.


New CRF completion guidelines

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


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:


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.


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.


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.


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.


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.


Summer Newsletter

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


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.

Please click here to view our past updates.