A trial comparing 2 different ways of giving radiotherapy for prostate cancer - PIVOTAL

This trial is comparing 2 different ways of giving radiotherapy for prostate cancer that may have 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.

The aims of this trial are to confirm that it is safe to give high doses of radiotherapy to the prostate and the lymph glands in the pelvis. And to compare the side effects of having radiotherapy to the prostate only and having radiotherapy to the prostate and pelvis.

Recruitment

Start 03/06/2011

End 31/08/2012

Phase

Phase 2

Who can enter

You can enter this trial if you

Have prostate cancer that has spread into the seminal vesicles or surrounding tissue (stage T3b or T4) – you doctor can advise you about this
Have been having hormone therapy for the last 6 to 9 months before starting radiotherapy
Have satisfactory blood test results
Are able to look after yourself (performance score 0,1)
Are at least 18 years old

You cannot enter this trial if

Your PSA blood test keeps rising after having hormone therapy
Your cancer has spread to the lymph glands
You are not able to have radiotherapy
You have had hip surgery that may affect you having radiotherapy – your doctor can advise you about this
You have already had radiotherapy to the area between your hip bones (pelvis)
You have had major surgery to the area between your hip bones
You have had any other cancer in the past 5 years, apart from basal cell skin cancer

Trial design

This is a phase 2 trial. Initially it will recruit 110 men. If they are able to cope with the treatment and it is acceptable, the research team will recruit more men.

You will be put into 1 of 2 groups by a computer. Neither you nor your doctor can choose which group you are in. This is called randomisation.

If you are in the first group, you have radiotherapy to the prostate only. Men in the second group will have radiotherapy to the prostate and the area between the hip bones (pelvis).

Both groups will have intensity modulated radiotherapy – IMRT. IMRT is a way of targeting the prostate cancer more exactly. This means that doctors are able to give a larger dose of radiotherapy just to the cancer.

You have radiotherapy daily, from Monday to Friday, for 7 and half weeks. Each treatment session takes between 10 and 15 minutes.

You will be asked to fill out a few questionnaires