• What are the advantages of taking part in PROVENT?

    We don’t yet know whether the drugs tested in PROVENT will help stop your prostate cancer progressing. However, if the trial is successful, the drugs may benefit you and other men in the future. You may also benefit from the PROVENT screening tests, where we check for a particular type of bacteria known to cause stomach ulcers and bleeding (Helicobacter pylori). This is easily treated with antibiotics, but often people don’t realise they have it.

  • Are there any disadvantages to taking part?

    Not in terms of your cancer treatment. You’ll be seen just as regularly as you would if you were on active surveillance and not in PROVENT. However, you will need to remember to take your drugs every day, and there is a small risk of side effects.

    Possible Side Effects of Aspirin

    Possible Side Effects of Vitamin D

  • Are there any alternative treatments to this study?

    If your doctor has invited you to take part in PROVENT, he/she thinks that monitoring your prostate cancer by active surveillance may be the most suitable treatment approach. If you have opted for active surveillance, the only alternative to taking part in PROVENT is not taking part. Your doctor will discuss with you the alternatives to active surveillance, which include radical surgery and radiotherapy.

  • Will my taking part in the study be kept confidential?

    Yes. During your Randomisation Appointment you will be assigned a number that will identify you throughout the study. Your name will not be used. We will, however, let your GP know that you’re taking part.

  • Can I start taking PROVENT drugs immediately?

    If you decide to take part, in the study, we’ll assess your suitability using some screening questions and tests. If you’re eligible to join PROVENT, you will need to attend an initial Randomisation Appointment, where we ask you some more questions and assign specific drugs/placebos to you. After this, you’ll be able to start taking your drugs.

  • How long will I be in the study for?

    After your Randomisation Appointment, you’ll be taking the PROVENT tablets and liquid drops for 18 months. If this ‘feasibility’ stage of PROVENT goes well, and a larger study is approved during your trial period, you may have the option to transfer to the larger study later. If your prostate cancer becomes more serious during the study, your doctor will reassess your treatment options and you may leave the study early.

  • How often will I need to attend appointments?

    After your initial Randomisation Appointment, you’ll need to attend appointments every three months. This schedule is exactly the same as it would be for normal (non-PROVENT) active surveillance patients.

  • Do I need to have a prostate biopsy?

    Yes, after 12 months you will need to have a biopsy. This is a normal part of active surveillance, so you would have this whether you joined the study or not. Your doctor may advise that you have an additional biopsy at any stage of your treatment if he/she considers it necessary, but this is a possibility whether you are a PROVENT Study participant  or not.

  • Can I leave the study once I have joined?

    Yes, you can leave the study at any time. You may, for example, decide that you want radical treatment after all. This should be discussed with your doctor, but you are under no obligation to stay in the trial. If you leave PROVENT, data and samples collected up to that point would be used as part of the study. If, for some reason, you should wish for your data and samples to be withdrawn, we ask that you express this in writing. The purpose of this stage of PROVENT is to work out whether a larger study would be feasible in the future, so we may ask why you have chosen to drop out.

  • What if new information becomes available about the PROVENT drugs?

    We’ll let you know if this happens. Depending on what the information is, you may have to sign a new consent form to continue with the study. Alternatively, you might wish to withdraw from PROVENT, or be advised to do so by your doctor.

  • What happens to any samples I give?

    We regard your samples (blood, urine, faeces and biopsy tissue) as ‘donations’ from you to Queen Mary University of London (QMUL). They’ll either be sent for testing straight away, or stored securely and indefinitely for later analysis, without any identifying personal details. Some samples may be sent outside the European Union for analysis, but will remain anonymous.

  • What happens at the end of the study?

    As long as your cancer remains the same, very little will change at the end of the study. You’ll stop taking your drugs, but will continue to be seen on active surveillance every three months. If we decide to expand the trial, you may be asked if you'd like to be part of the bigger study.

  • Who do I contact if I have a problem?

    For any queries about PROVENT, contact your study doctor/nurse at your study centre.

  • Who do I contact for more general advice on clinical trials?

    For independent advice on taking part in a clinical trial, please contact your study centre’s Patient Advice and Liaisons Service (PALS).

  • Who is organising and funding PROVENT?

    Funding is primarily from Bart’s and the London Charity. Cancer Research UK are providing additional funding for PROVENT project management. The drugs are being provided by Bayer Healthcare and Merck Sorono.

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