If, after reading the study Patient Information Sheet, you decide you'd like to take part in the PROVENT study, you will be asked some ‘screening’ questions to ensure you are suitable for the trial. If, after answering the questions, it turns out that you are not eligible, you will not be able to join the trial. If you are eligible, you will be asked to read and sign the consent form to confirm that you understand the study and that you agree to participate.
The consent will also allow us to take a small blood sample to check your calcium levels. Vitamin D3 can increase the amount of calcium in your blood, If the result of the blood test shows that your calcium level is too high to take part in the research, you will not be able to join the trial, as a safety precaution. Your well being is our priority.
If you are suitable for the study, then most of the procedures and tests you will have as part of the study are exactly the same as you would have if you were not taking part, with one or two exceptions.
Men who choose active surveillance for their treatment are normally seen in the clinic every three months, and this study is designed so that the research appointments coincide with those regular appointments. If you take part, the only extra clinic visit will be the randomisation visit, when you will be randomly assigned or 'randomised' to one of the 6 treatment arms of the study shown below. Neither you nor your doctor will be told which treatment arm you are allocated, this is what is known as a 'blinded' study
The 6 treatment arms of PROVENT study are:
- Aspirin 300mg + Vitamin D3
- Aspirin 300mg + Vitamin D3 placebo
- Aspirin 100mg + Vitamin D3
- Aspirin 100mg + Vitamin D3 placebo
- Aspirin placebo + Vitamin D3
- Aspirin placebo + Vitamin D3 placebo
PROVENT Visit 1: Randomisation Appointment
This is the only appointment that is additional to normal active surveillance visits. You’ll be asked to bring along a stool sample, in a provided pot, which will be sent for a helicobacter pylori test. We’d prefer that you didn’t have these bacteria in your gut while potentially taking Aspirin long-term, as Aspirin can affect the lining of the stomach. Helicobacter pylori is present in 30-40% of the population, but most people don’t know they have it. If we find that you do, you’ll be treated with antibiotics. Unfortunately, if you are unwilling to undertake treatment for the infection, you will be unable to continue on the PROVENT trial.
During your Randomisation Appointment, you will also have a rectal exam (a normal procedure for patients on active surveillance), after which we will collect a urine sample. We’ll then take a blood sample to test your baseline Vitamin D and hormone levels, and your study doctor/nurse will fill in a questionnaire with you.
Your specific PROVENT drugs will be assigned to you during this appointment, and you’ll be given them by your study research nurse or able to collect them afterwards at the pharmacy, depending upon local practice at the hospital you are attending. You will be given tablets and liquid drops. The tablets will be either Aspirin or a placebo (‘dummy’ drug), and the drops will be either Vitamin D3 or a placebo. Neither you or the staff looking after you will know whether you’ve been assigned the real drugs or the placebo, as they look and taste identical. Your doctor will give you a diary card to record any missed doses or side effects.
You’ll start taking your drugs straight after this appointment. If your helicobacter pylori test comes back positive, you will be treated with antibiotics while you continue to take your PROVENT drugs.
PROVENT Visits 2-7
After your Randomisation Appointment, you’ll come back every three months for 18 months. This appointment schedule is exactly the same as it would be for any other active surveillance patient.
You’ll have a prostate examination and a blood test at each visit. These two are standard procedures for all patients on active surveillance. Because of the trial, you’ll also fill in a questionnaire each time. On alternate visits (i.e. every six months), your doctor will collect an additional blood sample for research purposes, and give you a fresh supply of drugs.
At 12 months (just before your Visit 5) you’ll have an MRI scan and a prostate biopsy. Again, these are normal procedures for someone on active surveillance, and do not just happen because of the trial. We will, however, collect an additional urine sample during Visit 5, which is specific to PROVENT. If your MRI or biopsy results show that a change in treatment plan is required, you may leave PROVENT at this stage. If not, you will return as normal for Visits 6 & 7.