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

Please note this trial is no longer recruiting patients.

This trial is looking at using tadalafil in men after surgery for prostate cancer (prostatectomy). It is for men who have nerve sparing prostate surgery.

After this type of operation some men may still 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 can help men with erectile dysfunction between 1 and 4 years after surgery. But doctors are not sure if giving tadalafil sooner after surgery can help.

In this trial the researchers want to compare tadalafil with a dummy drug (placebo) soon after surgery to see if tadalafil can help men to maintain their erectile function.

Recruitment

Start 01/12/2009

End 03/06/2011

Phase

Phase 4

Who can enter

You can enter this trial if you

Have prostate cancer that has not grown outside the prostate gland (stages T1 to T2c)
Have a PSA blood result of 10 or less before surgery
Have a Gleason score of 7 or less before surgery
Have had surgery in the last 6 weeks
Have erectile dysfunction as a result of your surgery
Want to continue your sexual activity as soon as possible after surgery
Are 18 to 68 years old at the time of your surgery

You cannot enter this trial if you

Are to have radiotherapy or hormone therapy after surgery
Have a tube into your bladder to drain urine (urinary catheter) for more than 3 weeks after surgery
Have had treatment for prostate cancer before surgery
Have had problems with your erections before surgery
Have another medical condition that may cause weak erections
Have had treatment for erectile dysfunction before, including tadalafil, Viagra or similar drugs
Have had another medication in the past 30 days as a part of another clinical trial
Have had a penile implant
Have diabetes
Have liver problems
Have a serious heart condition
Have blood pressure problems
Have had a problem with your spinal cord or brain (central nervous system) within the last 6 months, including a stroke or a major injury
Have lost vision in one or both eyes due to a decrease in blood flow to the eye
Are known to be HIV positive
Take one of a group of drugs called nitrates (this is to treat angina - do not stop taking this medicine unless your doctor tells you to)
Have any other medical condition that could affect you taking part in this trial

The researchers would also like to invite your partner to take part in this trial. To take part your partner must be

Female
Your regular partner
At least 18 years old

Trial design

This is a phase 4 international trial. It will recruit about 690 men. It is a randomised trial. The men taking part are put into 1 of 3 groups by a computer. Neither you nor your doctor will be able to decide which group you are in or told which group you are in. This is called a double blind trial.

You will have medication to take once a day and medication to take when you want to have sex. For 2 of the groups one of these medications will be tadalafil and the other a dummy drug (placebo). For the other group both of these medications will be dummy drugs.

After 9 months you stop taking your medications for 6 weeks. This is to allow all the tadalafil and dummy drug to come out of your body. This is called a ‘washout’ period.

After this everyone will have tadalafil once a day for 3 months.

The researchers will ask you to fill in a number of questionnaires during the study, and to keep a diary. The questionnaires will ask about your sex life, how you are feeling, symptoms you have and your relationship with your partner.

If your partner is taking part in the trial, the researchers will ask her to fill in 3 questionnaires. She fills in the first one at the hospital when she agrees to take part in the trial. For the other 2 she can attend the hospital with you to fill them in or the research team may call her at home.