A trial comparing immediate treatment with active surveillance for newly diagnosed prostate cancer (ProSTART)

Please note this trial is no longer recruiting patients.

This trial is trying to find out if it is best for men with prostate cancer contained within the prostate gland to have treatment straight away or to have active surveillance.

If you are diagnosed with prostate cancer, your doctor may suggest that you have treatment such as surgery to remove the prostate gland, radiotherapy or brachytherapy. If the cancer is completely contained inside the prostate gland, the aim of these treatments is to cure the cancer. You may hear them called radical treatments.

But all treatments have side effects. For some men, the side effects of treatment are worse than any problems the cancer might cause. Prostate cancer can grow so slowly that it never causes any symptoms.

So, some men have active surveillance. This 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.

This trial is for men who have prostate cancer that their doctors think is unlikely to grow or spread for some years. The aim of the trial is to compare active surveillance with treatment intended to cure the cancer, to see which is better for this group of men.

Recruitment

Start 09/09/2008

End 04/12/2009

Phase

Phase 3

Who can enter

You can enter this trial if you

Have been diagnosed with prostate cancer in the last 6 months and it is entirely within the prostate (stage T1, T2a or T2b)
Have a Gleason score no higher than 6
Have a relatively low PSA level (less than 10 ng per ml)
Are well enough to take part in the trial (performance status 0,1 or 2)

You cannot enter this trial if you

Have cancer that has spread outside your prostate gland
Have already had any type of treatment for prostate cancer, apart from less than 3 months of anti androgen hormone therapy
Have had any other cancer, apart from non melanoma skin cancer or superficial bladder cancer that has been successfully treated, or another cancer that has been in complete remission for at least 5 years

Trial design

This is an international study. In the UK, it will begin by recruiting about 100 men in a pilot study. If recruitment is successful, the trial team then plan to extend the study into a full phase 3 trial which will recruit more than 2,000 men.

It is a randomised trial. The men taking part will be put into treatment groups by a computer. Neither you nor your doctor will be able to decide which group you are in.

If you are in group 1, you and your doctor will choose one of the following treatments

Surgery to remove your prostate (prostatectomy)
External beam radiotherapy
Brachytherapy

If you are in group 2, you have active surveillance. You will have a physical examination, digital rectal examination and PSA blood test every 3 months for 2 years and then every 6 months.

You will also have a biopsy of the prostate after 1 year, 4 years, 7 years and 10 years. After that you will have a biopsy once every 5 years.

Hospital visits

If you are in group 1, the number of hospital visits you have will depend on which treatment you have. After you finish treatment, you will continue to see the trial doctors every 6 months. At these visits, you will have a blood test and a digital rectal examination. You may have a transrectal ultrasound.

If you are in group 2, you will go to the hospital every 3 months for 2 years and then every 6 months after that. You will also go to hospital for a biopsy every 3 years for 10 years and every 5 years after that.

Side effects

All treatments have side effects and it is not possible to know in advance if they will be mild or severe. Many side effects get better shortly after treatment finishes. But sometimes they can be long lasting or permanent. Your doctor will monitor you closely during treatment and when possible will help to reduce or manage any side effects.

There is more information about the side effects of surgery, radiotherapy and brachytherapy on CancerHelp UK.

Any treatment for prostate cancer could affect your ability to father a child. If fertility is an issue for you, it is important to discuss this with your doctor before you start treatment. If you have radiotherapy, your doctors will advise you to use reliable contraception for 2 years after treatment. This is because sperm produced after treatment may still be fertile but could be damaged. This could cause abnormalities in a child conceived soon after radiotherapy.

The possible side effects of a prostate biopsy include