A study looking at giving 2 hormone treatments before surgery to treat prostate cancer (NEPTUNE)

Please note - this trial is no longer recruiting patients. We hope to add results when they are available.

Cancer type:

Prostate cancer

Status:

Closed

Phase:

Phase 2

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 testosterone Open a glossary item 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.

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 glands or pituitary gland
Are taking steroids for 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

Trial design

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.

NEPTUNE study diagram

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 local anaesthetic Open a glossary item .

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.

Hospital visits

Before you start the study you see the doctor and have some tests. These tests include

Physical examination
Heart trace
Heart ultrasound (echocardiogram )
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

Side effects of Orteronel and Leuprorelin together include

Tiredness (fatigue)
Hot flushes
Diarrhoea
Constipation
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