Prolaris test data change clinician, patient decisions about prostate cancer management

A new paper in the Journal of Urology provides us with some interesting if preliminary information on the ways that genetic/genomic tests of biopsy samples may be affecting first-line treatments for localized forms of prostate cancer.

We can comment at this time only on the abstract of the new paper by Shore et al. (since the full text of the paper is still unedited and therefore under embargo). According to that abstract, Shore and his colleagues have analyzed the ways in which results of the CCP test (i.e., the Prolaris test marketed by Myriad Genetics) have affected patients’ and clinicians’ about treatment. The analysis is based on data from > 1,000 newly diagnosed patients whose data were collected in the PROCEDE-1000 registry study.

In this study, newly diagnosed and untreated men with adenocarcinoma of the prostate were enrolled and given the Prolaris test on the biopsy samples provided to Myriad Genetics. A series of four sequential surveys were then implemented and used to track changes related to initial therapy recommendations (pre-CCP) based on clinopathologic parameters. The four surveys were conducted:

  • Prior to implementation of the Prolaris test (or at least prior to availability of the results of the Prolaris test)
  • After initial physician-only review of the Prolaris test results
  • After joint physician and patient review of and discussion about the Prolaris test results, and
  • At a minimum of 3 months of clinical follow-up (i.e., at the time of actual treatment)

Shore et al. report the following results:

  • Sufficient data were available on 1206/1596 patients enrolled in the registry (75.6 percent) who were thus eligible for analysis.
  • At each successive evaluation there was a significant reduction in the treatment burden recorded (P < 0.0001).
  • The average (mean) number of treatments per patient decreased from 1.72 prior to the Prolaris test to 1.16 at the time of the 3-month follow-up.
  • The results of the Prolaris test caused a change in actual treatment in 47.8 percent of patients.
    • 72.1 percent of these changes were reductions in treatment.
    • 26.9 percent of these changes were increases in treatment.
  • For each clinical risk category, there was a significant change in treatment modality (intervention vs. non-intervention) from before to after Prolaris testing (P = 0.0002).

The authors conclude only that use of the Prolaris test had

a significant impact in assisting physicians and patients reach personalized treatment decisions.

We have no idea at the present time whether the use of the Prolaris test helped the physician and the patient to reach “the best” decision about treatment for each individual patient. We also have no idea whether the changes in decision were subsequently validated by post-treatment outcomes data.

What is most certainly interesting about this study is that the results of genomic testing were leading to changes in the decisions made by clinicians and their patients about both the recommendations being made to patients by physicians about treatment and (b) the consequent decisions of the patients.

One Response

  1. I believe that earlier this year Medicare started covering the cost of this test for men diagnosed with low-risk prostate cancer (based on Gleason scores and whatever other factors are currently used to stratify prostate cancer severity). The reasoning seemed to be that if you have intermediate- or high-risk cancer, you will need to be treated and the test adds no further information. (The intermediate category is a little fuzzy). Medicare coverage was obviously an important goal for Myriad, and they have some press releases about it on their web site.

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