National Institute for Health and Clinical Excellence (NICE)
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NICE issues final diagnostics guidance on prostate cancer tests and consults on draft guidance on tests for bacterial infection and skin cancer

In final guidance issued yesterday 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. NICE has yesterday also issued draft diagnostics guidance on 5 tests that can show whether infections have been caused by bacteria. In its other draft diagnostics guidance issued yesterday for consultation, NICE has said that the VivaScope 1500 and 3000 systems (MAVIG) for diagnosing potentially malignant skin lesions (cancers) show promise but there is currently insufficient evidence to recommend their use in routine NHS clinical practice.

The NICE diagnostics guidance on PROGENSA PCA3 assay (Hologic GenProbe) and the Prostate Health Index (PHI) (Beckman Coulter) concludes that using the tests to help determine the need for a second biopsy 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.

The PROGENSA PCA3 assay and PHI are diagnostic tests that are intended for use in people with suspected prostate cancer, for whom an initial biopsy is being considered, or for whom a repeat biopsy is being considered following a negative or inconclusive 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 evidence on the use of these tests shows that, although there were some improvements in diagnostic performance when PCA3 or PHI was added to clinical assessment alone, these improvements were very small. There was also insufficient evidence to determine the clinical effectiveness of using the PCA3 assay or PHI in detecting more aggressive cancers.

“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.”

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