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A study looking at giving 2 hormone treatments before surgery to treat prostate cancer (NEPTUNE)
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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
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.
Who can enter
You may be able to enter this study if you
- Have prostate cancer
- Have a PSA of more than 10
- Haven’t had any treatment for prostate cancer before
- Are due to have surgery to remove your prostate
- Are well enough to carry out all your normal activities, apart from heavy physical work (performance status of 0 or 1)
- Have satisfactory blood test results
- Are willing to use reliable contraception during the study and for 16 weeks after if there is any chance your partner could become pregnant
- Are at least 18 years old
You cannot enter this study if you
- Are allergic to man made versions of a hormone called gonadotrophin releasing hormone (GnRH) - you can ask your doctor about this
- Have had any other cancer in the last 5 years that has needed drug treatment (
systemic treatment), unless this was as part of another treatment to cure your cancer, or was for non melanoma skin cancer or early stage transitional cell cancer of the urinary system
- Have a problem with your
adrenal glandsor pituitary gland
- Are taking
steroidsfor any reason
- Have a condition that affects how well your body would absorb the study drug, including having had any major surgery to your digestive system
- Have uncontrolled diabetes
- Are sensitive to the study drug or any of its ingredients – you can ask your doctor about this
- Have uncontrolled high blood pressure
- Have had serious heart problems or blood clotting problems in the last 6 months (if you have an abnormal heart rhythm called atrial fibrillation, and are taking blood thinning medication as part of this and both the condition and drug dose is stable you may still be able to take part)
- Have any other serious medical problems, such as a diagnosis of a disease where your immune system attacks body tissues (autoimmune disease) in the last 6 months, or infection such as hepatitis
- Have taken part in another clinical trial in the last 30 days
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 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
- Physical examination
- Heart ultrasound (
- MRI scan
- Blood tests
Everyone in the study will see the doctor and have a blood test
- 12 weeks after surgery
- Once a year for 3 years after surgery
If you are in group 2 you also see the doctor and have a blood test
- Every 4 weeks whilst you are on leuprorelin and Orteronel (you also have your leuprorelin injection at these visits)
- One week before your surgery (also with an MRI scan)
You also have a prostate biopsy and MRI scan 12 weeks after starting leuprorelin and Orteronel.
Side effects of Orteronel and Leuprorelin together include
- Tiredness (fatigue)
- Hot flushes
- Skin rash
- Taste changes
- High blood pressure
- Joint pain
- Raised blood sugar levels
- Problems getting an erection
- A drop in blood cells causing an increased risk of infection, bleeding problems, tiredness and breathlessness
- Short term changes to the way your liver works
- Low levels of potassium in your blood
Side effects biopsies include
How to join a clinical trial
Professor Thomas Powles
Experimental Cancer Medicine Centre (ECMC)
Millennium Pharmaceuticals, Inc
NIHR Clinical Research Network: Cancer
Queen Mary University of London