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

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:

Phase 2

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. This trial is supported by Cancer Research UK.

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.

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

  • Before randomisation
  • Before starting radiotherapy
  • 10 and 18 weeks after starting radiotherapy
  • Every 6 months for 2 years
  • Then every year for 3 years

They will ask you about how you are feeling and side effects you have had.

Hospital visits

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

During radiotherapy you see the doctor every 2 weeks.

After treatment you see the doctor at week 8, 10 and 18 to see how you are and what side effects you have.

You then see the doctor at 6, 12, 18 and 24 months for blood tests and a rectal examination.

Side effects

The short term side effects of radiotherapy for prostate cancer include

The long term side effects of radiotherapy for prostate cancer include

  • A feeling of wanting to strain, and bleeding from the back passage (proctitis)
  • Difficulty passing urine
  • Leaking urine (incontinence)
  • Difficulty getting an erection (impotence)

There is more information about radiotherapy and hormone treatment for prostate cancer on CancerHelp UK.

Recruitment start:

Recruitment end:

How to join a clinical trial

Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.

Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Chief Investigator

Professor David Dearnaley

Supported by

Cancer Research UK
Institute of Cancer Research (ICR)
NIHR Clinical Research Network: Cancer

Other information

This is Cancer Research UK trial number CRUK/10/022.

Questions about cancer? Contact our information nurses

Freephone 0808 800 4040

Last review date

CRUK internal database number:

Oracle 4548

Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Keith took part in a trial looking into hormone therapy

A picture of Keith

"Health wise I am feeling great. I am a big supporter of trials - it allows new treatments and drugs to be brought in.”

Last reviewed:

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