Are genomic tests “up to snuff” for routine use in prognosis of prostate cancer risk?

The Intergroupe Coopérateur Francophone de Recherche en Onco-urologie (ICFuro) has just published a review of the available evidence on the clinical validity and utility of six prognostic biomarkers available for the assessment of prostate cancer-related risk. The six biomarkers referred to are:

  • The Prostate Health Index or phi test
  • The 4KScore test
  • The Michigan Prostate Score or MiPS test
  • The Oncotype GPS test
  • The Prolaris test, and
  • The Decipher test

The paper by Lamy et al. on behalf of the ICFuro reports a systematic review and analysis of all published data on these six biomarkers from January 2002 through April 2015.

The basic finding of the review group was that

preanalytical and analytical validations were heterogeneous for all tests and often not adequate for the molecular signatures.

In other words, when these biomarkers were studied for specific uses — such as whether patients were good candidates for a first or second biopsy, or good potential candidates for active surveillance, or good portential candidates for treatment by radical prostatectomy or other adjuvant treatment — levels of evidence for the clinical utility of the six tests was varied.

However, the authors did conclude that the phi test and the 4KScore test were the two tests offering the highest levels of evidence for being able to discriminate between aggressive and indolent tumors in different indications. They therefore also concluded that these were the two tests (out of the six tests examined) that could best help clinicians to manage their patients with prostate cancer at the present time.

The authors stated further that:

The other biomarkers show a potential prognostic value; however, they should be evaluated in additional studies to confirm their clinical validity.

Obviously the commercial developers of the tests like the Oncotype GPS test, the Prolaris test, and the Decipher test are not going to be too happy about the findings of this paper. It should be noted, also, that these findings do not mean that the results of such tests have no value. On the other hand, the implication is that the routine use of such tests is not justified by the currently available data.

4 Responses

  1. I think the marked genetic heterogeneity of tumors, as noted by Klotz in the talk you posted recently, is a challenge that has to be met before I want to place any reliance on these tests. In the worst case, they could give the sort of false sense of security offered by some 12-needle biopsies.

    When will your posting rate slow?!

  2. OK. But what about recent trends in restaging using imaging? Would a test indicating aggressive prostate cancer be as good as an image that could guide personalized treatment?

    I believe a meta-analysis does not give an answer, as modern restaging with imaging is changed dramatically in recent years.

  3. Thanks! Excellent summary of the current utility of these genomic tests.

  4. Dear Finn:

    The authors of this paper didn’t look at imaging. They only looked at the tests referred to. However, other papers have pointed out that the quality and utility of imaging also depends on a whole range of factors, most particularly including the type of imaging, the size of the tumor, and the skill and experience of the radiologist reading the images (of which the last appears to be paramount).

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