A study looking at the best way to take tissue samples to diagnose prostate cancer (The TRANSLATE Study)

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:

Other

This study is for men whose doctor refers them to hospital for suspected prostate cancer.

More about this trial

Your GP may refer you to hospital for more tests for prostate cancer if:

a prostate check shows abnormal signs such as lumps or hard areas
you have a PSA level that is high for someone of your age

Your specialist at the hospital may then arrange for you to have an MRI scan to check for abnormal areas. Sometimes prostate cancer doesn’t show up on the scan and so you might need to give a sample of tissue (biopsy Open a glossary item ). This involves taking small samples of tissue from the prostate gland. A specialist in the laboratory uses a microscope to look for prostate cancer in these samples.

There are 2 main ways of having a biopsy done in the NHS. Most hospitals take a biopsy during a transrectal ultrasound scan (TRUS). This is called a transrectal biopsy. Some hospitals now use a newer technique called a transperineal biopsy. Doctors don’t know which is best, so they are running this study to find out more.

The main aims of the study are to find out:

which way of doing the biopsy works best to diagnose prostate cancer
which has the fewest possible complications such as infection or other side effects
more about the costs

Please note, taking part in this study might not help you directly. It might help men in the future who have a prostate biopsy to detect cancer.

Who can enter

The following bullet points are a summary of the entry conditions for this study. Talk to your doctor or the study team if you are unsure about any of these. They will be able to advise you.

Who can take part

You may be able to join this study if all of the following apply. You:

are male
have suspected prostate cancer either because:
o your PSA level is higher than it should be for your age or
o you have abnormal areas such as lumps or hard areas

As well as the above the following must also apply. You:

are suitable to have a tissue sample (biopsy) taken from your prostate
can read and understand English
are at least 18 years old
have had an MRI scan of the prostate before the biopsy

Who can’t take part

You cannot join this study if any of these apply. You:

have ever had a prostate biopsy in the past
have a PSA level above 50 ng/ml
have problems with recent urine infections, or a suspected or proven urine infection around the time of the biopsy
might need to take extra antibiotics at the time of biopsy. This is to stop you from getting an infection, for example if you have a catheter to drain urine. Your doctor will know this.
have a problem with how your immune system works
can’t lay down in the correct position to have the prostate biopsy

Trial design

The study team need 1,126 men to take part. The team ask you to fill in a short questionnaire about your medical history before you are put into a group. This takes about 10 minutes.

This is a randomised study. A computer puts you into a biopsy group. Neither you nor your doctor can decide which group you are in.

There are 2 groups. You have a local anaesthetic Open a glossary item for both biopsies. You have your biopsy done in 1 of 2 ways:

transrectal ultrasound (TRUS) guided transrectal biopsy under local anaesthetic. This is the technique that has been used for many years
transperineal biopsy under local anaesthetic (LATP). This is the newer technique and is also guided by transrectal ultrasound.

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Transrectal biopsies
The doctor or nurse takes your biopsies through the back passage (rectum). They usually take about 12 to 16 biopsies. This depends on:

the size of the prostate and
the findings from the MRI scan performed before the biopsy

Transperineal biopsies
The doctor or nurse takes your biopsies through the perineum (the skin between the scrotum and the back passage). They usually take about 12 to 16 biopsies.

The samples are then sent to the laboratory as usual. In the laboratory, a specialist doctor looks at the samples under the microscope.

Please note, being part of this study won’t affect your hospital care or the standard treatments you might need.

Questionnaires
You fill in a short questionnaire after the procedure to see how you are and if you had any side effects. You do this at:

7 days
35 days
4 months after the biopsy

Each questionnaire takes between 5 and 15 minutes to fill in. The team email the questionnaire to you. They can post it if you prefer.

Hospital visits

There aren’t any extra tests if you take part in this study. You will still have any necessary blood tests, scans and treatment as part of your routine care.

Side effects

The study team monitor you during the biopsy and afterwards. Contact your advice line or tell your doctor or nurse if any side effects are bad or not getting better.

Transrectal and transperineal biopsies are safe but there are some possible risks. Some of the possible risks include:

blood in your urine and semen
infection, including going to hospital with a serious blood infection. This is called (sepsis )
bruising or discomfort in the prostate
not getting enough biopsy samples or having an unclear biopsy result. In this case your doctor may need to do a further biopsy procedure to get more samples.
problems passing urine and sometimes needing to go to hospital to have a catheter put in to drain urine (a urinary catheter)
temporary problems getting an erection

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