Welcome!

100 patients at four more sites!

Belfast City, the Royal Preston, Churchill Oxford and the Royal Devon and Exeter have all now recruited over 100 patients. We would like to thank and congratulate all of these sites for their valuable contribution and hard work.

STAMPEDE reaches 4000 patients!

STAMPEDE has reached yet another recruitment milestone with our 4000th patient randomised to the trial at the beginning of April! Thank you to all our centres for continuing to recruit so impressively.      

STAMPEDE end of recruitment to arm B, C and E (protocol minor amendment)

STAMPEDE has completed recruitment to research arms B, C and E as a sample size has been reached that is sufficient to provide the targeted power within the foreseeable future. As previously explained, this constitutes a minor amendment to the protocol and some of the supporting documentation.

Protocol, appendices, PIS General Part 1 and 2, GP letter and consent form

All the above mentioned documents are now version 10.0 (April 2013). Minor changes have been made to these documents to reflect the end of recruitment.

The documentation has been submitted to the REC and MHRA for information and we expect an acknowledgement to come through in the following weeks. As the amendment is considered a non-substantial one, all documents have immediate effect and can be used from Tuesday 2^nd April.  Letters of acknowledgement from REC and MHRA will follow soon.

Please submit these documents to your R&D departments for approval. The STAMPEDE team doesn’t require a confirmation of the submission or of the approval.

As most of you are already aware, closing a research arm is something STAMPEDE has implemented before so you should be familiar with the process. Closing the original comparison arms B, C and E has different underlying reasons from those that lead to suspend recruitment to the celecoxib arms (as arms D and F were suspended due to intermediate analysis). You might find interesting reading about closing arms D and F in one of the STAMPEDE publications issued by the online journal Trials. Here is a link for you http://www.trialsjournal.com/content/10/1/39

Please find below the updated docments:

a. Protocol version 10.0

b. Appendices version 10.0

c. PIS General Part 1 version 10.0

d. PIS General Part 2 version 10.0

e. Consent form version 10.0

f. GP letter version 10.0

g. Cover letter sent to REC and MHRA. Please read this letter as it contains important and relevant information on the amendment and conduct of the trial

Arm G PIS (substantial amendment)

A further amendment has been made to the Arm G-specific PIS version 9.0. The substantial amendment has been made as a result of a recent communication by the manufacturer of abiraterone acetate (Janssen) which warns that caution should be taken when handling the IMP by pregnant women and women who may become pregnant. All centres have been notified of such communication on 28- Feb-2013.

Please forward the PIS and notification of amendment to your R&D departments so that they are aware an amendment is coming through in due course. REC and MHRA approval is pending.

Re-consent is not required for ongoing patients. More details on the recent communication regarding pregnancy and abiraterone were described in an email to all centres sent on 28^th of February. We advised all centres to circulate the information to all subjects, caregivers and study staff but deemed the risk low and therefore re-consent is not required.

a. Arm G PIS version 10.0

b. Notification of Amendment form (Annex 2)

STAMPEDE editorial published

A recent STAMPEDE editorial on prostate radiotherapy for men with metastatic disease is now available online: http://www.sciencedirect.com/science/article/pii/S0936655513000915

Survey to sites for new research comparison

The STAMPEDE Trial Management Group is considering a proposal to introduce a further new research arm to assess a combination of abiraterone, steroids and enzalutamide, all in addition to standard hormone therapy (and, radiotherapy if N0M0). This proposal follows the successful activation of the abiraterone and M1/RT comparisons, and the excellent recruitment from sites in the UK and Switzerland.

The TMG feels that there is a convincing rationale for investigating this combination, but would only proceed if our investigators are supportive. We are in discussions with the relevant companies concerning access to the drugs. If this combination were to be activated, a new arm would likely be introduced at the end of 2013 or early in 2014.

A short summary of the proposal can be found here.

Here is a link to a short survey which we would like you to complete by lunchtime on Monday 4th March to comment on the draft proposal: http://survey.mrc.ac.uk/stampedeabienza/

This should take 5 minutes to complete. Please discuss the proposal with your colleagues and feel free to forward as you see fit for others to comment.

We plan to hold a Q&A session via teleconference/Webex on week commencing 25^th February with the clinical lead for this new comparison, Dr Gert Attard, to address any questions you and your team might have about this new comparison arm. Details will follow in due course.

Radiation Oncology in Prostate and Bladder Cancer- Current and Future Concepts Meeting

We have been asked by a member of the STAMPEDE trial management group to draw your attention to the Radiation Oncology in Prostate and Bladder Cancer - Current and Future Concepts Meeting taking place in Munich next month as you may find it interesting. We are told that data from the PR07 trial are being presented. Further information can be found here.

Launch of RT-to-the-prostate comparison for M1 disease

On 22-Jan-2013, randomisation was switched to a new comparison of radiotherapy-to-the-prostate for men with metastatic disease. This is activated with the implementation of Version 9.0 of the STAMPEDE protocol.

Patients will now be randomised between (A) standard care, (B) zoledronic acid + standard care, (C) docetaxel + standard care, (E) zoledronic acid + docetaxel + standard care, (G) abiraterone plus standard care and, now, (H) radiotherapy-to-the prostate + standard care.

Men with non-metastatic disease or disease that has previously been treated with local therapy or who have a contraindication to RT cannot, of course, be allocated to the new arm, Arm H.

Standard care continues to be hormone therapy for all men, with the addition of standard RT for all men with N0M0 disease.

The new comparison will comprise men allocated to Arm H and Arm A, and will include about 1200 consenting men over 4 years. The lead clinical investigator for this “M1/RT comparison” is Dr Chris Parker.

All sites have been trained, but approvals need to be in place for randomisation to continue.

STAMPEDE Protocol Version 9.0: Changes to the protocol which necessitate re‑consenting patients on arm G (abiraterone)

The latest version of the STAMPEDE protocol which is activated on 22‑Jan‑2013 includes new information relevant to the selection of patients suitable for arm G and the monitoring of patients who have been treated with abiraterone. Please find here a letter summarising changes to the protocol which necessitates administrative re-consenting patients in Arm G. Please read this information carefully and return by fax or email the declaration signed by the PI . Once R&D approval is received by your centre for protocol version 9.0, please ensure Arm G patients are re-consented at the first convenient opportunity (eg follow up clinic).