A study looking at a urine test to diagnose prostate cancer (PCa001)

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 looking at a urine test as a way of diagnosing prostate cancer. The test measures a protein called Mcm5 which stands for mini chromosome maintenance protein 5.

If you have symptoms that could be caused by prostate cancer, you are likely to have a PSA blood test. Your doctor will also feel your prostate gland by putting a gloved finger into your back passage. This is called a digital rectal examination or DRE.

If the level of PSA in your blood is high, you may then have a prostate biopsy. But although a high level of PSA can be a sign of cancer, it can also be raised in conditions other than cancer. So some men won’t need a biopsy.

Researchers are looking for ways to work out which men with a raised PSA are unlikely to have prostate cancer, so could avoid having a biopsy.

The aim of this study is to see if a urine test called Urosens Mcm5-ELISA can help to diagnose prostate cancer. If the test can do this, in future it may lead to fewer men having a biopsy they don’t need.

Who can enter

There are 2 parts to this study. Men were able to join the first part of the study if they had been diagnosed with prostate cancer and were going to hospital for further tests or treatment.

You may be able to join the second part of the study if you need to have a biopsy after a blood test showed a raised level of PSA, or your doctor felt something abnormal during your digital rectal examination (DRE).

And for both parts of the study, you must be

At least 18 years of age
Able to provide a urine sample

You cannot enter this trial if you

Have swelling or an infection in your prostate gland
Have kidney or bladder stones
Have had bladder cancer, kidney cancer, or cancer that started elsewhere but has spread to these organs
Have had any medical procedure on your urinary system in the last 14 days (the trial team can advise you about this)
Have had a prostate biopsy in the last 6 weeks

Trial design

There are 2 parts to this study. The first part of the study tested urine samples from about 40 men with prostate cancer who were going to hospital for treatment or a follow up appointment.

They saw the doctor or nurse and had a digital rectal examination (DRE). They then passed urine into a special collection tube that separates the first bit of urine passed from the rest of the sample.

This part of the study was to find out if testing the first part of the urine sample for proteins gives a better result than testing the whole sample.

The second part of the study is recruiting men who are going to have a biopsy after having either an abnormal rectal examination or a high PSA blood test result (or both).

Before having your biopsy, you have another rectal examination and pass urine into a special collection tube.

During the biopsy, the doctor will put a small probe into your back passage (rectum). The doctor then puts a very fine needle inside the probe and uses it to take some tissue samples from your prostate gland.

The researchers will compare the results of the biopsy and the urine test to see if the urine test can accurately diagnose prostate cancer.

Hospital visits

There will be no additional hospital visits as a result of taking part in this study. The trial team will ask you to have a digital rectal examination and to provide a urine sample. This will not affect other tests and treatment you have.