Local hospital headed paper

GP Letter: CONFIRMATION OF TRIAL RANDOMISATION

Version 16.0, Mar 2017

Dear Dr ______

STAMPEDE: SYSTEMATIC THERAPY FOR ADVANCING OR METASTATIC PROSTATE CANCER

Your patient, PATIENT NAME, has agreed to participate in a clinical trial named STAMPEDE. This is an international trial for patients with locally advanced or metastatic prostate cancer who are about to commence long-term hormone therapy (androgen deprivation therapy). It evaluates the effectiveness of interventions for this stage of prostate cancer. Patients are randomised either to the control arm of the trial, the current standard-of-care (SOC), or to one of the current recruiting research arms.More than 8,000 patients have joined the trial so far.

Treatment details

Your patient has been randomised to the marked arm:

A:Standard-of-care
K: Standard-of-care+ metformin
L: Transdermal oestradiol

Standard-of-care = androgen deprivation therapy ± docetaxel ± radiotherapy

Patients allocated to the control arm or the metformin treatment group will receive standard hormone therapy via one of the methods described below. This continues to be prescribed according to local practice.

Standard-of-care Hormone Therapy / LHRH agonist
will be given by: / LHRH antagonist
Orchidectomy
Dual androgen blockade (DAB)

Patients allocated to receive transdermal oestradiol will receive this as an alternative form of hormone therapy.

Enclosed with this letter is a copy of the information that has been supplied to the patient about this trial. This includes generalinformation, treatment specific information and details about optional additional research conducted as part of the trial.

For any patient experiencing side effects suspected to be related to trial treatment, the preferred hospital for admissions is:

Please contact: (Name and telephone number)

Details of trial screening investigations and monitoring

Life-long follow-up data is required for all patients randomised into STAMPEDE.

PSA Levels: The trial protocol requires regular monitoring of prostate-specific antigen (PSA) levels. In the future we may ask if your surgery could assist in taking blood samples to reduce hospital visits for participants.

Diabetic screening: Metformin is being evaluated within the trial as an additional anti-cancer treatment in non-diabetic patients. Diabetic screening using HbA1cis required for all patients who are not already known to have diabetes.Should this screening test be abnormal, consistent with a new diagnosis of type 2 diabetes, the patient will be informed and a separate letter sent to you to confirm this.

Cardiovascular events: the trial protocol collects data on cardiovascular disease therefore we ask for your assistance in alerting the hospital research team if patients experience cardiovascular symptoms or significant events e.g. heart disease, strokes or thrombosis. Although current safety data does not demonstrate transdermal oestradiol to increase cardiovascular risk, it may be pre-cautionary to stop treatment following a cardiovascular or thrombotic event; please contact the hospital consultant to enable assessment.

Genetic analysis: STAMPEDE participants may be invited to take part in additional research which may involve genetic analysis of tumour tissue, and/or saliva and blood samples. Results arising from this research could have implications for trial participants and their biological relatives. Participants may opt to find out about the results of these genetic analyses. Only results for which known medical implications and for which testing would be available under standard NHS genetic testing guidelines will be reported. Participants will be referred to clinical genetics for confirmatory testing and genetic counselling.

More information can be found in the trial protocol available on the STAMPEDE website:

For non-urgent queries relating to your patients treatment or trial participation please contact the consultant, as detailed on the accompanying correspondence.

Yours sincerely,

______

Hospital Consultant

More information about the study

STAMPEDE (ISRCTN number: ISRCTN78818544) uses a multi-arm, multi-stage design which means that the data is reviewed at planned intermediate analyses during the course of the trial. The trial started accrual in 2006, except forArm G (2011),Arm H (2012), Arm J (2014), Arm K (2016) and Arm L (2017).

The trial is funded by Cancer Research UK with support from Astellas, Janssen, Novartis, Sanofi-Aventis, Clovis and Pfizer, sponsored by the Medical Research Council (MRC) and coordinated by the MRC Clinical Trials Unit at UCL.

STAMPEDE website:

ISRCTN website:

GP LetterVersion 16.0Mar 2017