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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.
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.
The aims of this trial are to confirm that it is safe to give high doses of radiotherapy to the prostate and the
Who can enter
You can enter this trial if you
- Have prostate cancer that has spread into the
seminal vesiclesor 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
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
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.
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.
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)
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.
Professor David Dearnaley
Cancer Research UK
Institute of Cancer Research (ICR)
NIHR Clinical Research Network: Cancer
This is Cancer Research UK trial number CRUK/10/022.