A study of active surveillance, aspirin and vitamin D in men with prostate cancer (PROVENT)

Please note - this trial is no longer recruiting patients. We hope to add results when they are available.

Cancer type:

Prostate cancer

Status:

Closed

Phase:

Other

This study is for men having regular monitoring for prostate cancer contained within the prostate gland (localised prostate cancer).

More about this trial

Prostate cancer can grow so slowly that it never causes any symptoms. So, some men with localised prostate cancer have regular monitoring. This is called active surveillance. It means you don’t have treatment straight away. Your doctor keeps a close eye on you to check for any signs that the cancer is growing. If it does, then you and your doctor will decide which treatment is best for you.

Some newer research suggests that having aspirin and vitamin D3 can stop cancer from growing and changing. So researchers want to find out more. In this study, they want to see how useful these drugs are in men having active surveillance.

This is a feasibility study. This helps the study team to check the design before running a larger trial. The aims of this study are to find out:

how willing men are to take part
how well treatment works for prostate cancer that has a low risk of growing or spreading

Who can enter

The following bullet points list the entry conditions for this study. Talk to your doctor or the study team if you are unsure about any of these. They will be able to advise you.

You might be able to join this study if all of the following apply. You

Have stage T1 or T2 prostate cancer that hasn’t spread outside the prostate
Have a PSA level that is less than or equal to15
Have a Gleason score of 6 or 7
Are having or due to have regular monitoring (active surveillance) of your prostate cancer
Have had an MRI scan of your prostate within a year of joining the study and the doctor took tissue samples (biopsies) of any lesions found
Have satisfactory blood test results
Are at least 16 years old

You cannot join this study if any of these apply. You

Cancer related

Have had treatment for prostate cancer including radiotherapy, hormone therapy, brachytherapy or surgery

Medical conditions

Have or have had bleeding anywhere in your stomach or bowels, peptic ulcer, severe indigestion or inflammatory bowel disease
Have a bleeding condition called haemophilia or any other bleeding problem such as thrombocytopenia
Have had kidney stones in the past
Have severe, long term kidney problems
Have high levels of calcium in your blood or a condition called hyperparathyroidism that isn’t well controlled with medication
Have any bowel condition such as a fistula that would make taking tissue samples via the rectum risky or difficult
Have had any other cancer apart from non melanoma skin cancer that has been successfully treated in the last 5 years
Have any other serious medical condition that would make repeat prostate biopsy risky such as significant bleeding problems
Have severe asthma
Have a genetic disorder called G6PD that affects red blood cells
Have an eye condition called macular degeneration

Other

Are taking aspirin, non steroidal anti inflammatory drugs (NSAIDS) or vitamin D3 or you have taken 6 months of aspirin or vitamin D3 within 2 years of joining this study
Are taking or have taken drugs such as finasteride or dutasteride
Are sensitive or allergic to aspirin or NSAIDS such as ibuprofen or naproxen
Can’t have aspirin or vitamin D3 for any reason or you are taking any medicine that might interact with these
Drink more alcohol than the recommended daily limit of 3 to 4 units per day

Trial design

This feasibility study is based in the UK. The researchers need 102 men to take part.

It is a randomised study. You are put into 1 of 6 groups. Neither you nor your doctor will be able to decide which group you are in. And neither of you will know which group you are in either. This is called a double blind study. You have 1 of the following:

the usual dose of aspirin (300mg) and vitamin D3
the usual dose of aspirin and dummy drug (placebo ) vitamin D3
low dose aspirin (100mg) and vitamin D3
low dose aspirin and dummy vitamin D3
dummy aspirin and vitamin D3
dummy aspirin and dummy vitamin D3

study diagram

Aspirin and dummy aspirin are tablets. You take aspirin or the dummy drug once a day, everyday.

Vitamin D3 and dummy vitamin D3 are an oily liquid. You have a few drops once a day, everyday. You can take them on their own, soaked in some bread or in a small amount of fruit juice.

You have treatment for up to a year and a half.