
"I was delighted to take part in a clinical trial as it has the potential to really help others in the future.”
Please note - this trial is no longer recruiting patients. We hope to add results when they are available.
This trial is looking at a gel that contains the male hormone to see if it helps men who have low levels of testosterone after cancer treatment. The trial is supported by Cancer Research UK.
We know from research that men aged 25 to 50 who have had treatment for cancer may have lower levels of testosterone than other men. A low testosterone level may cause
Men who have very low levels of testosterone can have treatment to replace the hormone. But doctors are unsure of the best way to help men who have testosterone levels that are just a bit lower than normal. They call this a borderline low level.
The aim of this study is to see if a gel containing testosterone can help men with borderline low levels of testosterone following cancer treatment. The researchers want to see if it can help reduce body fat, and improve sex drive and general wellbeing.
You may be able to enter this trial if you
As well as the above, if you've had a bone marrow transplant using cells from a donor, you must have finished at least a year ago. If you are taking hormone replacement drugs, you must have been on stable doses for the last 6 months.
You cannot enter this trial if you
The trial will recruit up to 268 men. It is a randomised trial. The men taking part are put into treatment groups by a computer. Neither you nor your doctor will be able to decide which group you are in. And neither of you will know which group you are in either. This is called a double blind trial.
Men in one group use a gel called Tostran that contains testosterone. Men in the other group use a gel that looks the same but does not contain any testosterone (a ).
You use the gel everyday for 6 months in the trial. You spread it on your tummy or the inside of your thighs. The trial team will tell you exactly how and when to use the gel. They will also give you a leaflet to take home.
The researchers will ask you to complete some questionnaires before you start treatment, after 3 and 6 months of treatment. The questionnaires will ask about your health and general wellbeing, your self-esteem and your sex life. Some of these questions are very personal and explicit. If there are any questions that you don’t want to answer, or are not able to answer, you can miss them out.
All the information you give is . You put the completed questionnaires into an envelope that is sealed and sent to the researchers at the University of Leeds. Your answers will only by seen by people who don’t know your name.
You see the trial doctors and have some tests before you start treatment. This includes blood tests and a whole body scan using X-rays (a DXA scan).
You have another blood test after 2 weeks. Depending on the results of this test, the trial team may tell you to change the amount of gel you use.
You have hospital visits after 3 and 6 months of treatment. At these visits, you have blood tests. A member of the trial team will take a measurement around your waist as well as weighing you and checking your blood pressure. At the last visit you will also have another body scan.
A common side effect of the gel is skin irritation such as a rash, dry skin, itching or redness in the areas where you have been applying the gel.
Other less common side effects of Tostran include
You have blood tests during the trial and if your doctor thinks that you have any significant side effects, they can take you off the study.
Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.
Professor Richard Ross
Cancer Research UK
Clinical Trials Research Unit (CTRU)
Experimental Cancer Medicine Centre (ECMC)
University of Leeds
NIHR Clinical Research Network: Cancer
ProStrakan
Sheffield Hospitals Charity
Sheffield Teaching Hospitals NHS Foundation Trust
University of Sheffield
This is Cancer Research UK trial number CRUK/10/012
If you have questions about the trial please contact our cancer information nurses
Freephone 0808 800 4040
"I was delighted to take part in a clinical trial as it has the potential to really help others in the future.”