A trial looking at dexamethasone, aspirin and diethylstilbestrol for men with prostate cancer that has spread

Cancer type:

Prostate cancer




Phase 3

This trial tried to find out if it was better to start diethylstilbestrol straight after having treatment for prostate cancer that had spread or later on.

When prostate cancer spreads outside of the prostate gland, or to elsewhere in the body, it may be treated with hormone therapy. But it can continue to grow despite this treatment.

One treatment doctors may use is a combination of dexamethasone, aspirin and diethylstilbestrol. Dexamethasone is a steroid, aspirin is a type of anti inflammatory drug and diethylstilbestrol is a type of hormone therapy.

We know from earlier studies that these drugs can lower the level of a substance in the blood called the prostate specific antigen (PSA). This can be measured by a blood test. Doctors use PSA test results to follow the progress of treatment for some men with prostate cancer. If the PSA level is raised at diagnosis, it often comes down again when treatment has started to work.

Doctors have found that more than half of the men who have dexamethasone, aspirin and diethylstilbestrol have a drop in their PSA level. This means that the cancer has stopped growing or is not growing as quickly.

The researchers of this trial wanted to improve on this. They wanted to find out if it was better to start diethylstilbestrol straight away with dexamethasone and aspirin, or at a later stage.

The aims of this trial were to find out if delaying the start of diethylstilbestrol

  • Was better at controlling the cancer
  • Had less side effects

Summary of results

The trial team found that there was not much difference between starting diethylstilbestrol straight after treatment and delaying it.

Of the 270 men recruited everyone had dexamethasone and aspirin

  • 137 started diethylstilbestrol straight away
  • 133 did not

The researchers found no significant difference between the 2 groups when they looked at

  • How the cancer responded to treatment
  • Average amount of time it took for the cancer to start growing again
  • Average time men lived

The side effects of diethylstilbestrol were

  • An increased risk of blood clots
  • Painful and enlarged breasts

The trial team concluded that starting diethylstilbestrol straight away did not control prostate cancer better than delaying it.

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

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

Dr Jonathan Shamash

Supported by

Barts Health NHS Trust
Experimental Cancer Medicine Centre (ECMC)
NIHR Clinical Research Network: Cancer
Orchid Cancer Appeal
Queen Mary University of London

If you have questions about the trial please contact our cancer information nurses

Freephone 0808 800 4040

Last review date

CRUK internal database number:

Oracle 662

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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