A trial to see if the early use of tadalafil can help with sexual function after surgery for cancer of the prostate

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Cancer type:

Prostate cancer




Phase 4

This trial looked at using tadalafil in men after surgery for prostate cancer. It is for men who had prostate surgery (prostatectomy) that was nerve sparing. After this type of operation some men may have problems getting erections. You may hear this called erectile dysfunction. This means you are not able to get an erect penis, or keep it erect enough for sexual activity.

We know from research that tadalafil helped men with erectile dysfunction between 1 and 4 years after surgery. But doctors were not sure if giving tadalafil sooner after surgery could help.

In this trial the researchers compared tadalafil with a dummy drug (placebo Open a glossary item) soon after surgery to see if tadalafil helped men to keep their erectile function.

Summary of results

The trial team found that having tadalafil once a day after prostate surgery helped men to keep their erectile function.

This was a phase 4 trial. Of the 583 men recruited, 423 men were randomised and 422 men had treatment. The men taking part were put into 1 of 3 treatment groups. Neither they nor their doctor could choose which group they were in and neither knew which group they were in. This is called a double blind trial.

  • 139 men took tadalafil once a day and a dummy drug (placebo) when they needed it
  • 142 men took tadalafil when they needed it
  • 141 men took a dummy drug when they needed it

After 9 months of treatment the men stopped treatment for 6 weeks. This was to allow the tadalafil and the dummy drug to come out of their body. After this everyone took tadalafil once a day for 3 months.

At the end of the 9 months treatment, the researchers measured the erectile function of each individual man. In the group of men who had tadalafil every day, a larger number had kept more of their erectile function than in the group who had the dummy drug. This could not have happened by chance and so it was statistically significant Open a glossary item.

After the 6 weeks of no treatment, there was no statistical significant difference in the erectile function between the 3 groups of men.  

Overall after having tadalafil once a day for 3 months, the erectile function of the men had improved in all groups.  

The trial team concluded that having tadalafil once a day after prostate surgery did help men maintain their erectile function.

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.

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

Mr Hiten Patel

Supported by

Eli Lilly and Company Limited
NIHR Clinical Research Network: Cancer

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Last review date

CRUK internal database number:

Oracle 5670

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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