A trial looking at a short course of radiotherapy to treat prostate cancer (IMRT)

This trial is looking at having a short course of radiotherapy to treat prostate cancer that has spread or may spread to the lymph glands in the pelvis. The pelvis is the area surrounded by your hip bones.

Doctors often treat prostate cancer with, hormone therapy, surgery or external radiotherapy.

Intensity modulated radiotherapy (IMRT) is a way of targeting the areas of prostate cancer more exactly. This means that doctors are able to give a larger dose of radiotherapy to the cancer and a lower dose to surrounding healthy tissue. By doing this the side effects of radiotherapy may be reduced.

If you have radiotherapy, the treatment usually takes about 7 weeks. It may be possible to have IMRT over a shorter period of time. The men taking part in this trial will have IMRT treatment for 5 weeks.

The aim of this trial is to see if a 5 week course of IMRT can reduce the side effects of radiotherapy.

Recruitment

Start 01/03/2000

End 31/01/2013

Phase

Phase 1

Who can enter

You can enter this trial if

You have prostate cancer that has spread or may spread to the lymph glands in the pelvis (your doctor can advise you about this)

You cannot enter this trial if

Your doctors don’t think radiotherapy is the best treatment for you
You have had radiotherapy to the pelvis before
You have had surgery to the pelvis other than surgery to remove the prostate
You have bowel disease

Trial design

This is a phase 1 study. Everyone taking part will have 5 weeks of radiotherapy to the prostate and the lymph glands in the pelvis. You have 4 days of radiotherapy each week.

Before you start radiotherapy you will have 6 to 12 months of hormone treatment. The hormone treatment will continue after the radiotherapy for a total of 3 years.

You will be asked to fill out a questionnaire

Before starting radiotherapy
Every 6 months for 2 years
Then every year for 3 years

It will ask how you have been feeling and about any side effects that you have had. This is a called a quality of life questionnaire.

Hospital visits

You will see the doctor and have some tests before you take part in this trial. These tests include

Blood tests including PSA test
Physical examination including rectal examination
Biopsy
MRI scan or CT scan

You go to the hospital on 4 week days each week for radiotherapy. You will do this for 5 weeks. You will have more blood tests during your radiotherapy course.

After finishing radiotherapy you will have

Regular appointments with your doctor
A PSA test every 6 months for 5 years
Rectal examination every 6 months for 2 years and then every year for 3 years

If your doctor thinks that your prostate cancer is growing again, you will have a CT scan or MRI scan, and a bone scan. Your doctor will then discuss treatment options with you.