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A trial looking at 2 different ways of giving radiotherapy for prostate cancer (PIVOTAL)
This trial looked at radiotherapy for prostate cancer that had grown outside the prostate but had not spread to lymph nodes or another part of the body. It was supported by Cancer Research UK.
More about this trial
The men taking part in this trial had prostate cancer that was at risk of spreading to the lymph glands in the pelvis. The pelvis is the area surrounded by your hip bones. When this trial was done, the standard treatment for men in this situation was radiotherapy to the prostate, but not the pelvic area.
Everyone taking part in this trial had intensity modulated radiotherapy (IMRT). Some men had radiotherapy to the prostate only. And some had radiotherapy to the prostate and pelvic area.
The research team wanted to find out more about the side effects of these two types of radiotherapy.
This trial was done to see how well people cope with high doses of radiotherapy to the prostate and the lymph glands in the pelvis.
Summary of results
This trial showed that pelvic radiotherapy for prostate cancer didn’t cause too many serious side effects.
The research team recruited people between 2011 and 2013, and published the results in 2018.
This trial recruited more than 120 men with prostate cancer that had grown outside the prostate, and doctors felt may spread to their pelvic lymph nodes.
The men taking part were put into 1 of 2 groups at random, and:
- half had radiotherapy to their prostate only
- half had radiotherapy to their prostate and pelvis
The research team looked at the side effects people had during and after treatment. They looked how many people in each group had side effects that affected their bladder or bowel. These include problems such as:
- inflammation or bleeding from the back passage (rectum)
- inflammation of the bladder
- needing to pass urine more often than usual
Bowel side effects
Some men had side effects that were mild or short lived. But a few had more serious side effects.
The biggest difference between the 2 groups was 6 weeks after starting radiotherapy, when the number of men having more serious side effects was:
- 4 out of 61 people (7%) who had radiotherapy to the prostate
- 16 out of 61 people (26%) who had radiotherapy to the prostate and pelvis
Over time the number of people with bowel side effects, and difference between the two groups, got smaller. The number of men having more serious side effects was similar in both groups by about 4 months (18 weeks):
- 2 people (3%) who had radiotherapy to the prostate
- 3 people (5%) who had radiotherapy to the prostate and pelvis
Bladder side effects
The number of men with bladder side effects was very low and similar in both groups. The side effects were worst about 8 weeks after starting treatment.
How well treatment worked
The main aim of this trial was to look at side effects, but the research team also looked at how well the treatments worked in the first 2 years.
They found that the cancer had grown or spread to another part of the body in a small number of men in each group. But it’s hard to draw any firm conclusions from a phase 2 trial because of the relatively small number of people taking part.
Quality of life
The people taking part completed several questionnaires to see how the treatment affected their quality of life. Researchers call these ‘patient reported outcomes’. They included questions about possible bowel and bladder problems.
The research team found that the answers were similar for the two groups. People in both groups reported more bowel problems 10 weeks after joining the trial. They had fewer problems as time went on.
The trial team concluded that radiotherapy to the prostate and pelvis was safe and didn’t cause too many serious side effects. It may be a useful treatment for prostate cancer, but researchers need to find out more about how well it works.
We have based this summary on information from the research team. The information they sent us has been reviewed by independent specialists (
How to join a clinical trial
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.