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In draft guidance NICE has said that two new tests to help diagnose prostate cancer in people who have had a negative or inconclusive prostate biopsy have not demonstrated enough of an impact compared to current clinical practice to be recommended for use in the NHS in England.

Draft diagnostics guidance on PROGENSA PCA3 assay (Hologic GenProbe) and the Prostate Health Index (PHI) (Beckman Coulter) published today for consultation concludes that using the tests does not lead to improvements  in the  diagnosis of  prostate cancer that are either large enough or consistent enough to influence current clinical diagnostic practice.

Prostate cancer is the second most common cause of cancer death among men in the UK and in 2010 there were 10,721 deaths from prostate cancer in the UK.

Prostate cancer is more common in men aged 65 and over, but under-65s can be affected too. Men from a black African-Caribbean family origin are three times more likely to develop the disease compared with white Caucasian men. It can be very slow growing and whilst many men will have a cancer that won’t cause them any harm in their lifetime, nearly 10,000 men still die every year in England and Wales.

Diagnosis of prostate cancer often involves a biopsy of the prostate gland. A biopsy is an invasive procedure and is associated with complications such as discomfort, bleeding and urinary retention.

Detection rates of prostate cancer are around 14-25% for first biopsy and it is estimated that a significant proportion of people may receive a false negative result and require further investigations, including a second biopsy, to rule out prostate cancer.

Biopsies can be a significant source of anxiety for patients, and even more so for a second biopsy because of the patient’s previous experience of the procedure. This can lead to many patients preferring to have a general anaesthetic for a second biopsy, or even to decide not to have a second biopsy.

The PROGENSA PCA3 assay and PHI are diagnostic tests that are intended for use in people having investigations for suspected prostate cancer who have had a negative prostate biopsy. The tests detect specific biomarkers that, when present in the blood at high levels, can suggest the presence of cancer. Both tests are intended to be used in conjunction with a review of risk factors, such as raised prostate specific antigen (PSA) levels and digital rectal examination findings, to help determine the need for a second biopsy to rule out the presence of prostate cancer.

By indicating which patients have a decreased likelihood of a positive biopsy result and therefore are unlikely to have prostate cancer, these tests might help avoid the need for second biopsies and their associated complications.

Professor Carole Longson, NICE Health Technology Evaluation Centre Directorsaid: “Prostate biopsies are associated with discomfort and pain, as well as side effects including bleeding, problems with catheterisation and possible infections. These tests would be of value if they were able to improve diagnostic certainty because it would reduce the number of prostate biopsies patients had to have, reducing patients’ anxiety.

“However, the committee noted from the evidence that although there were some improvements in diagnostic performance when PCA3 or PHI was added to clinical assessment alone, these improvements were very small.

“NICE has recommended MRI as part of the clinical assessment in men whose initial prostate biopsy is negative to help decide whether a second biopsy is needed, and this is now commonly used as part of clinical assessment. The evidence suggests that where MRI is used to help determine the need for a second biopsy, adding PCA3 or PHI had little or no benefit.

“The committee concluded that when the effectiveness of the two tests was compared to clinical assessment, the potential improvement in diagnostic accuracy was small and therefore they couldn’t be recommended as a good use of NHS resources.”

For more information call the NICE press office on 0300 323 0142 or out of hours on 07775 583 813.

Notes to Editors

About the draft diagnostics guidance on PROGENSA PCA3 assay and the Prostate Health Index to help diagnose prostate cancer

• The draft diagnostics guidance on prostate cancer tests is available on the NICE website at http://www.nice.org.uk/guidance/indevelopment/gid-dt20

About the NICE Diagnostics Assessment Programme

• For further information about the NICE diagnostics assessment programme see Developing NICE diagnostic technologies guidance  

Topics to be considered by the Programme are routed through the related Medical Technologies Evaluation Programme. Further information about this can be found at Developing NICE medical technologies guidance

About NICE

The National Institute for Health and Care Excellence (NICE) is the independent body responsible for driving improvement and excellence in the health and social care system. We develop guidance, standards and information on high-quality health and social care. We also advise on ways to promote healthy living and prevent ill health.

Our aim is to help practitioners deliver the best possible care and give people the most effective treatments, which are based on the most up-to-date evidence and provide value for money, in order to reduce inequalities and variation.

Our products and resources are produced for the NHS, local authorities, care providers, charities, and anyone who has a responsibility for commissioning or providing healthcare, public health or social care services.

To find out more about what we do, visit our website:www.nice.org.uk and follow us on Twitter: @NICEComms.