A trial to see if triptorelin can shrink the prostate gland before radiotherapy (EDVART)

Cancer type:

Prostate cancer

Status:

Results

Phase:

Phase 2/3

This trial looked at triptorelin before radiotherapy for prostate cancer, to see whether it can shrink the prostate gland.

It was open for people to join between 2011 and 2013, and the team published the results in 2019.

More about this trial

Doctors can treat prostate cancer with a number of treatments including surgery, radiotherapy, and hormone therapy. The men taking part in this trial were having radiotherapy to try to cure their prostate cancer.

We already knew from research that having hormone therapy for 3 months before radiotherapy can shrink the prostate gland. This helps the radiotherapy to work better.

When this trial was done, doctors often used a hormone therapy called goserelin (Zoladex).

In this trial, the researchers compared goserelin with another hormone therapy called triptorelin (Decapeptyl). It works in a similar way to goserelin. When this trial was done, triptorelin had been looked at in trials for men with more advanced prostate cancer.

The aims of the trial were to find out:

whether triptorelin works as well as goserelin at reducing the size of the prostate gland
more about the side effects and how the treatments affect men’s quality of life

Summary of results

The research team found that triptorelin and goserelin both helped reduce the size of the prostate.

Trial design
The men taking part in this trial had all been diagnosed with prostate cancer, and were due to have hormone therapy and then radiotherapy. They were having hormone therapy first to help reduce the size of their prostate.

They were put into 1 of 2 treatment groups - half had triptorelin and half had goserelin.

They all had a trans rectal ultrasound scan (TRUS) before and after their hormone therapy. And had regular blood tests to measure their PSA and testosterone levels.

They also completed various quality of life questionnaires before, during and after treatment:

one was designed for anyone taking part in any trial (EQ5D)
one was for people with any type of cancer (QLQ-C30)
one was specifically for people with prostate cancer (QLQ PR25)

Results
A total of 71 men took part in this trial. They were put into 1 of 2 groups at random:

37 had triptorelin
34 had goserelin

Diagram 1

The research team measured the size (volume) of everyone’s prostate gland, before and after treatment. They then worked out the average prostate size, and the average change in size. They found that the prostate got smaller in both groups.

They measured the prostate in cubic centimetres (cc). A cubic centimetre is the same size as a millilitre (ml).

For men who had triptorelin the prostate changed from an average of 38cc before treatment, to an average of 27cc afterwards. This is a reduction in size of 11cc.

For men who had goserelin the prostate changed from an average of 38cc before treatment, to an average of 24cc afterwards. This is a reduction in size of 14cc.

Bar Chart 1

The difference between the 2 groups isn’t big enough to say for sure that it’s due to the different treatments. It could be due to chance. So these results suggest that triptorelin is as good as goserelin.

Quality of life
The research team found that there was no difference between the two groups for nearly all the quality of life assessments.

The men who had goserelin had slightly worse ‘hormone symptoms’ such as hot flushes or sore breasts.

Conclusion
The trial team concluded that triptorelin was as good as goserelin at reducing the size of the prostate before radiotherapy. And it didn’t decrease the men’s quality of life.

Where this information comes from
We have based this summary on information from the research team. The information they sent us has been reviewed by independent specialists (peer reviewed Open a glossary item ) and published in a medical journal. The figures we quote above were provided by the trial team who did the research. We have not analysed the data ourselves.