A trial looking at intermittent versus continuous hormone therapy in advanced prostate cancer (EORTC 30985)

Cancer type:

Prostate cancer

Status:

Results

Phase:

Phase 3

This trial was comparing intermittent hormone therapy with continuous hormone therapy for prostate cancer that had spread.

If prostate cancer has spread to another part of the body, doctors can treat it with the hormone therapy drugs goserelin (Zoladex) and bicalutamide (Casodex). But hormone therapy has side effects, which can be very difficult for some men.

In this trial, researchers wanted to find out if stopping and starting the drugs (intermittent treatment) worked as well as taking them all the time (continuous treatment). And to see if this improved quality of life.

Summary of results

This trial did not show that intermittent hormone therapy worked as well as continuous treatment.

The trial enrolled more than 3,000 men. Everybody had hormone therapy for 7 months. They had regular blood tests to monitor the level of a protein called PSA. Men who had a PSA of 4 ng/ml or less (and wasn’t rising) in months 6 and 7 could be put into 1 of 2 treatment groups. Neither the men, nor their doctors could decide which group they were in. This is called randomisation.

The researchers randomised 1,749 men to either

Carry on having hormone therapy (continuous treatment)
Stop having hormone therapy at this point (intermittent treatment)

All the men taking part had a PSA test each month and saw the trial team every 3 months.

The men in the intermittent treatment group only started hormone therapy drugs again if their PSA level went up, or if they developed symptoms. After a further 7 months of treatment, they could stop the treatment again if their PSA level had gone back down to a low level. They could then stay off treatment until their PSA level started to go up again or their disease started to get worse.

The researchers found that the average (median) length of time men lived after randomisation was

5.8 years in the continuous therapy group
5.1 years in the intermittent therapy group

Three months after being randomised, men in the intermittent therapy group reported fewer problems getting an erection and improved mental health. But after 15 months, there was not any real difference in reported quality of life between the 2 groups.

The researchers concluded that this trial couldn’t show that intermittent hormone therapy worked as well as continuous hormone therapy in terms of survival.

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 ) and published in a medical journal. The figures we quote above were provided by the trial team. We have not analysed the data ourselves.