A trial comparing treatment approaches for prostate cancer (ProtecT)

Please note this trial is no longer recruiting patients.

This trial is looking at radiotherapy, surgery and active monitoring to find the best treatment for localised prostate cancer.

It can be difficult to decide which treatment is best for prostate cancer that is completely inside the prostate (localised prostate cancer). The options include radiotherapy, surgery (radical prostatectomy) or careful monitoring with regular check ups. At the moment no one knows which of these 3 options is best.

This study will compare these 3 approaches to treatment

Active monitoring
Radical radiotherapy
Radical prostatectomy

The aim of the study is to find out which is best for localised prostate cancer. And what men with prostate cancer think about the 3 options.

Please note, you cannot volunteer to take part in this study. If you are eligible to join the study and are registered with a GP practice involved, you may be asked if you would like to take part.

Recruitment

Start 01/06/1999

End 31/12/2008

Phase

Phase 3

Who can enter

You can enter this study if you are

A man aged between 50 and 69 years old
Well enough to have surgery or radiotherapy
Registered with a GP practice that is taking part in the study
Invited to take part

You cannot enter this study if you have had

Any other cancer, apart from non melanoma skin cancer that has been successfully treated
Treatment for prostate cancer already
A heart attack or stroke, have congestive heart failure or any other serious heart condition
Chronic obstructive lung disease (COPD) or any other serious lung problems
A kidney transplant or have regular kidney dialysis
Both hips replaced

Trial design

Recruitment To being with, your GP will write you a letter asking if you would like to take part. They will also send you some information about the study to read. If you agree to take part, they will send you some more detailed information.

You will also see a research nurse who you can talk to about the study. If you are happy to have a PSA test, the research nurse will take a blood sample. You have 24 hours to be sure you are happy to go ahead, and if you are, the amount of prostate specific antigen (PSA) will be measured in your blood sample.

Doctors want to find out how PSA testing for prostate cancer affects men’s feelings and emotions. To find this out the researchers are doing a small study as part of the ProtecT trial. This is called a sub study, For the sub study you will fill in some questionnaires when you have the PSA test. And if you need to have a biopsy you will fill in the questionnaires several more times. The questionnaires will ask you about symptoms, such as difficulty passing urine. And they will ask you about your feelings and emotions. You can read more about the sub study on CancerHelp UK Some of the men taking part will also be asked to fill in a 7 day diet diary.

Diagnosis

About 9 out of 10 men (90%) who have the PSA test will not have a raised PSA level. The 1 in 10 men (10%) who have a raised PSA level will have more tests.

If your PSA is between 3 and 20, will have another PSA test, a biopsy, and a rectal examination (DRE). If further tests show that you have prostate cancer that is contained within the prostate (localised prostate cancer), you are eligible for the next part of the trial.

If your PSA is over 20, you will have another PSA test and other tests. Depending on the results of these, you may be eligible for the next part of the trial. If you are found to have prostate cancer that has spread outside the prostate gland, you will not be able to take part in the next part of the trial. Your doctor will discuss the treatment options with you at the time.

Treatment

If you are eligible for the trial, you will see a specialist doctor who will talk to you about your diagnosis. You will then see a research nurse to discuss all the treatment options.

One option is active monitoring. You will have a PSA test every 3 months for the first year, and then every 6 to 12 months after that. You may have a rectal examination (DRE) once a year. If there are any signs that your prostate cancer has started to grow you will discuss whether you should have surgery or radiotherapy, or continue with active monitoring.

Another option is conformal radiotherapy. Radiotherapy aimed at curing prostate cancer is called radical radiotherapy. Before you have radiotherapy you will have hormone therapy for 3 to 6 months. This will help shrink the cancer and make radiotherapy easier. Then you will have radiotherapy every day, Monday to Friday, for 6 to 8 weeks.

The third option is surgery. You will have an operation to remove your prostate called a radical prostatectomy.

If there are signs that your prostate cancer has started to grow again, your doctor will discuss the other treatment options with you. You may be able to have radiotherapy, or you may have hormone therapy, for example.

Hospital visits

You will see the research team at the start of the trial, as described above. How often you go to hospital after that depends on which group you are in.

If you are in the active monitoring group you will go to the hospital for tests every 3 months for the first year and every 6 to 12 months after that.

If you are in the radiotherapy group you will have radiotherapy every weekday for 6 to 8 weeks. You have treatment as an outpatient. After that you will see the doctors every 3 months for a year, then every 6 months for a year, and once a year after that.

If you are in the surgery group, the operation will take a few hours. You will be in hospital for 4 to 7 days altogether. You will go home with a tube in place to drain urine from your bladder (urinary catheter). A week or 2 later you will go back to the hospital to have the catheter removed, and to make sure you are able to pass urine without it. You will see the doctors again 6 weeks later, and then every 3 months after that.

Side effects

The short term side effects of radiotherapy for prostate cancer include

The longer term side effects of radiotherapy for prostate cancer can include

The feeling of wanting to strain and bleeding from your back passage (proctitis)
Difficulty passing urine or leaking urine (incontinence)
Difficulty getting an erection (impotence)

The most common side effects of surgery for prostate cancer are