
"Health wise I am feeling great. I am a big supporter of trials - it allows new treatments and drugs to be brought in.”
Please note - this trial is no longer recruiting patients. We hope to add results when they are available.
This study is looking at an injection called leuprorelin (Prostap) and an experimental drug called Orteronel (TAK 700) to see if together they can reduce the risk of prostate cancer coming back after surgery to remove the prostate.
If you have prostate cancer that has not spread beyond the prostate, you may have surgery to remove the prostate. But because there is a risk that prostate cancer can come back, researchers are looking at giving different drug treatments before surgery, such as hormone therapy or chemotherapy.
Researchers in this study are looking at a combination of hormone therapies before surgery for prostate cancer. These are an injection called leuprorelin, which is already used to treat cancer that has spread beyond the prostate. And, an experimental drug called Orteronel, which is looking promising in studies in men with prostate cancer that is advanced or has spread. When given together, they work to reduce levels in the body. Reducing testosterone levels may stop the cancer growing.
The study team will recruit men due to have surgery to remove their prostate. Half will have a course of leuprorelin and Orteronel before this surgery. The aim of this study is to see if giving leuprorelin and Orteronel for 6 months can reduce the risk of the cancer returning after surgery to remove the prostate.
You may be able to enter this study if you
You cannot enter this study if you
This study will recruit 136 men. It is randomised. Everyone taking part will be put into one of 2 groups by a computer. Neither you nor your doctor will be able to decide which group you are in.
If you are in group 1, you have surgery to remove your prostate. You have your surgery within a month of joining this study.
If you are in group 2, you have a course of Orteronel and leuprorelin, followed by surgery to remove your prostate. You take Orteronel in the morning and evening, 12 hours apart. You also fill out a diary to show the team when you took it. You have leuprorelin as an injection under your skin, which your research nurse will give every 28 days.
You have an MRI scan and, if you agree, a biopsy of your prostate, after about 3 months of taking these drugs. You have the biopsy under .
You have your surgery between 23 and 25 weeks after starting Orteronel and leuprorelin.
Whichever group you are in, your study doctor will contact your GP or other specialist once a year for 3 years, to see if you have had any prostate cancer related issues. You also see the study doctor at these times. After this, you continue to see your regular specialist in the same way as before you joined the study.
Before you start the study you see the doctor and have some tests. These tests include
Everyone in the study will see the doctor and have a blood test
If you are in group 2 you also see the doctor and have a blood test
You also have a prostate biopsy and MRI scan 12 weeks after starting leuprorelin and Orteronel.
Side effects of Orteronel and Leuprorelin together include
Side effects biopsies include
Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.
Professor Thomas Powles
Experimental Cancer Medicine Centre (ECMC)
Millennium Pharmaceuticals, Inc
NIHR Clinical Research Network: Cancer
Queen Mary University of London
Freephone 0808 800 4040
"Health wise I am feeling great. I am a big supporter of trials - it allows new treatments and drugs to be brought in.”