"Health wise I am feeling great. I am a big supporter of trials - it allows new treatments and drugs to be brought in.”
A study looking at dutasteride as a possible prostate cancer treatment (MAPPED)
Please note - this trial is no longer recruiting patients. We hope to add results when they are available.
This study is to see if the drug dutasteride can shrink prostate cancer in men whose doctors are closely monitoring their disease (active surveillance). This drug is usually used for men with an enlarged prostate who have problems passing urine.
If you have prostate cancer that may never need treatment, you may have active surveillance. This means that you see your doctor regularly for blood tests, rectal examinations and prostate biopsies. And avoid side effects of prostate cancer treatment until you definitely need to have it. If your cancer starts to grow, you will have treatment aimed at curing your cancer (radical treatment). But not all men are happy to just have active surveillance. Researchers are looking for a simpler treatment that can control early prostate cancer and lower the risk of a man needing more intensive treatment.
In this study, they will look at the drug dutasteride. We know from research that men at an increased risk of prostate cancer who take the drug for 4 years are less likely to have a biopsy that shows cancer.
The research team think dutasteride may also shrink some prostate cancers. And it may lengthen the time a man can stay on active surveillance. In this study men will take dutasteride or a dummy drug (placebo). They will also have a series of scans, including a powerful type of MRI scan, which can measure the volume of cancer in the prostate. The aim of the study is to see if dutasteride reduces the volume of prostate cancer seen by using MRI scans.
Who can enter
You can enter this study if you
- Have prostate cancer
- Have had a biopsy showing prostate cancer in the last 2 years
- Are under active surveillance
- Have cancer that is large enough to be measured on an MRI scan – you can check this with your doctor
- Have satisfactory blood tests
- Are able to take capsules
- Would be able to read the study questionnaires and complete them yourself
- Are under 80 years of age
You cannot enter this study if you have ever had any of the following treatments for prostate cancer
- Hormone therapy
- Steroid tablets called glucocorticoids, for example dexamethasone
- Finasteride or dutasteride or another similar drug in the last 12 months – you can check this with your doctor
- Anabolic steroids in the last 6 months
- Any drug in the last 6 months that could affect how the body makes and uses the male sex hormone – you can check this with your doctor
You also cannot enter the trial if you
- Are not able to have MRI scans (for example you a have a
pacemakeror metal in your body, or cannot cope with being in small spaces)
- Cannot have the MRI contrast gadolinium for any reason
- Have had a hip replacement, and your doctor thinks this would affect the quality of the MRI pictures
- Have any other condition that would affect the quality of study MRI scans – you can check this with your doctor
- Have had any other cancer in the last 5 years
- Have had any heart condition in the last 6 months that is a cause for concern
- Have had a stroke or a mini stroke (TIA) in the last 6 months
- Have uncontrolled diabetes
- Have a stomach ulcer that is not controlled with medication
- Have any other condition that would make you unwell, or affect the results of the study – you can check this with your doctor
- Are allergic to any drug in the same family as, or that is similar to, dutasteride – you can check this with your doctor
- Have taken part in any clinical drug trial in the last 30 days
This phase 2 study will recruit 42 men into 2 groups. It is a randomised study. The men taking part are put into 2 groups randomly. Neither you nor your doctor will be able to decide or know which group you are in. This is called a ‘double blind’ study.
If you are in group 1, you will take a dutasteride capsule every day for 6 months.
If you are in group 2, you take a dummy capsule (placebo) every day for 6 months.
You fill out questionnaires at regular points during the study. These will ask you about any difficulties you may have passing urine or having sex.
Everyone will also have a series of scans throughout the study, using a powerful MRI scanner, and a type of ultrasound scan called a Histoscan. You will also have a prostate biopsy at the end of the study.
The team will look at all these results and compare them with any changes to your prostate that can be seen from the scans or biopsy.
After you finish the study you continue to see your regular cancer specialist in the same way as you did before.
Before you start the study, and 3 times during the study, you will see the doctor and have some tests. These include
- Examining your prostate (rectal examination)
- Urine test
- Blood tests, including a PSA blood test
You have an MRI scan (for 1 hour)
- Before you start the study
- After 3 months
- After 6 months
And a Histoscan ultrasound (for half an hour)
- At the start of the study
- After 6 months
You have a prostate biopsy at 6 months.
Common side effects of dutasteride include
- Difficulty getting an erection
- Decrease in the desire to have sex (decreased libido)
- Problems with ejaculation
- Breast enlargement or tenderness
Side effects of prostate biopsy include
- Discomfort during the biopsy – you will have painkillers for this
- Infection - you have antibiotics to help prevent this
- A small amount of bleeding into your urine, semen and stool (faeces) for a short time after the test
Very rarely, MRI contrast dye can cause an allergic reaction. Staff at the MRI unit will be able to treat this if it happens.
How to join a clinical trial
Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.
Professor Mark Emberton
Clinical Imaging Centre
NIHR Clinical Research Network: Cancer
University College London (UCL)
University College London Hospitals NHS Foundation Trust