NICE concludes that PCA3, phi tests not clinically useful


The National Institute for Health and Care Excellence (NICE) has issued draft guidance stating that two approved tests for risk of prostate cancer are not clinically useful in England.

A report on the Medscape web site, based on draft diagnostics guidance issued by NICE on December 17, recommends that the Progensa PCA3 test and the Prostate Health Index (the phi or PHI test) should not be used in the National Health Service in England. Specifically, the guidance indicates that these tests, which were approved to help identify prostate cancer in patients with negative or inconclusive results on initial prostate biopsy, do not improve diagnosis enough to be recommended for clinical practice, given other, current guidelines in England.

It is important in understanding this new NICE guidance to be aware that NICE has already approved the use of multiparametric MRIs (using T2 and diffusion-weighted imaging) in England for men with a negative TRUS-guided biopsy to decide whether a repeat biopsy is advisable. NICE guidance states that such a repeat biopsy should be offered if either (a) an mpMRI is positive or (b) an mpMRI is negative but one or more of the following risk factors exists:

  • High-grade prostatic intraepithelial neoplasia (HG-PIN) on the initial biopsy
  • Atypical small acinar proliferation (ASAP) on the initial biopsy
  • An abnormal digital rectal examination (DRE)

Given this guidance, it is not difficult to see why NICE would conclude that the use of PCA3 or the phi test is of very limited value. However, since the use of mpMRI is not yet considered to be routine in the USA, the situation here, and in other countries too, may be (at least arguably) rather different.

Whether the PCA3 and phi tests may have value in determining whether a patient needs a first biopsy is not addressed in this guidance for the simple reason that neither test has ever been evaluated or approved for such use in Europe. (The PCA3 test has never been approved for such use in the USA either, although the phi test has been so approved.)

4 Responses

  1. I had two negative biopsies and a PCA3 test that all indicated cancer was not present. Ended up with Gleason 10 three months after the PCA3 test.

  2. The scarcity of 3-T or better MRI devices may be a critical delimitation.

    Phil Olsen

  3. Not approved in USA? Not approved by whom?

    I had PSA of 6 and no prior biopsy. Medicare and Aetna Supplemental reimbursed in full for my PCA3 test in early 2014.

  4. Dear John.

    My error. The phi test is approved in the USA by the US FDA (but not in Europe) for use prior to a biopsy. The PCA3 test is only approved for use after an initial negative biopsy in both Europe and the USA.

    The fact that some payers will cover the costs of such tests outside their approved indication is a separate issue.

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