A trial looking at a new injection to improve scans to diagnose prostate cancer

Who can enter

You can enter this trial if you

• Have prostate cancer that has been confirmed with a biopsy
• Have prostate cancer that is completely inside the prostate gland and you are due to have surgery to remove your prostate (radical prostatectomy) OR
• Have prostate cancer that has broken through the covering of the prostate (‘locally advanced’), are due to have radiotherapy and are willing to have an operation called ‘surgical pelvic lymph node staging’ to help plan your radiotherapy OR
• Have prostate cancer that has spread to other parts of your body (‘metastasised’)
• Have satisfactory blood tests
• Are well enough to take part (performance status 0, 1 or 2)
• Are willing to spend a day at hospital having the different scans, blood and urine tests involved
• Are willing to use reliable contraception during the trial and for 6 months afterwards if there is a chance that your partner could become pregnant
• Are at least 18 years old

You cannot enter this trial if you

• Will be having chemotherapy or radiotherapy within 2 weeks either side of the start of the trial
• Have had major surgery to your chest (thoracic surgery) or your tummy (abdominal surgery) and have not yet recovered
• Have recent severe problems with your heart rythmns (cardiac arrhythmia)
• Have a condition where your heart can’t pump blood properly (congestive heart failure)
• Have heart disease that severely limits or may stop physical activity, or makes you breathless at rest or after light activity
• Have an uncontrolled infection
• Have any other condition that would make you unwell if you took part, or affect the results of the trial – you can check this with your doctor

Trial design

This trial will recruit about 50 people with prostate cancer. Everyone will have an injection with 99mTcDB4, a number of scans and tests to see how 99mTcDB4 affects the body.

On the first day of the trial you will see the doctor and have a heart trace (ECG). You will have 99mTcDB4 as an injection into a vein in your arm or the back of your hand. You will stay connected to the heart monitor for about 15 minutes after your injection. You will then have between 5 and 7 scans during the day including scans using a gamma camera, CT scans and SPECT scans. You must lie very still during the scans, but will be free to get up and walk around after each set of scans.

During the day you will give about 11 blood samples. You give each blood sample from a single needle that stays in your arm for the whole day. The team may also need to insert a thin, flexible tube (urinary catheter) into your bladder. This may be a little uncomfortable, but you will have some numbing gel (anaesthetic) to the area before the tube goes in. The catheter drains urine into a bag. This keeps your bladder empty so that doctors have a clear view of your prostate on the scans. The team will also be able to take regular urine samples from the tube.

After you have finished your scans the staff will check your blood pressure and pulse, and you will have another heart trace (ECG). You then go home.

The next day a research nurse will telephone you at home to see how you are and answer any questions you may have. The trial team will then contact you each week to find out when you will be starting your planned treatment, which is not part of the trial.

On day 29 of the trial you will see the team and give another blood and urine sample (you will not need a tube into your bladder this time). If your treatment is due before this time you will have an extra check up before you start this.

Over the next year, your trial doctor may look at any information collected about you to do with your cancer. This will help them work out how accurate the 99mTcDB4 scans are.

If you are due to have surgery, the team will also ask your permission to keep a sample of the cancer that will be removed. This will help researchers to learn more about prostate cancer treatment. You do not have to agree to this if you do not want to. You can still take part in the trial.

During and after the trial you will continue to see your regular specialist doctor.

Hospital visits

Before you start the trial, you will see the doctor and have some tests. These tests include

• CT scan or MRI scan
• Physical examination
• Heart trace (ECG)
• Blood test
• Urine test

On the first day of the trial you will come to the hospital for your injection and scans. This will take around 7 hours, so you will be at the hospital for most of the day.

At the end of the trial you will see the team for your final check up. You will also have an extra check up if your treatment is due to start before this time.

Side effects

This is the first time that 99mTcDB4 has been given to people. From research in the laboratory, the team expect possible side effects to include

• Tiredness
• Blushing
• Irregular heart beat
• Possible rise in blood pressure

As 99mTcDB4 is a new drug, there may be side effects researchers do not know about yet. This is one of the reasons for this trial. If you have any medical problems it is important that you contact your trial doctor.

The amount of extra radiation exposure you will have from 99mTcDB4 is low.  

The amount of extra radiation exposure you have from the scans depends on the number you have. You can talk to your trial team if you have any concerns about this.