Our Review Summary
This is a story about a potential new test that may improve the ability to determine when a man with elevated circulating PSA levels has prostate cancer and perhaps better predict if the prostate cancer that a man has is aggressive or not. While mentioning in passing that additional studies are necessary to determine whether this set of tests really does improve the ability to predict the behavior of a man’s prostate cancer, the overall tone of this story was that this test is the tool that doctors have been waiting for. The enthusiasm for a new test ought to be tempered until there is sufficient data demonstrating that it is successful. It is certainly worth noting that while many other markers have been evaulated to improve the accuracy of the PSA test, few have been widely adopted and none have been rigorously evaluated for effectiveness in clinical trials.
Why This Matters
Having tools that better predict whether a prostate cancer is aggressive would be useful for helping men avoid treatment that isn’t needed. Whether this test will prove to be useful in this regard remains to be demonstrated.
Criteria
Not Satisfactory
Although the story included price estimates for prostate biopsy, it did not include a ball park estimate for the cost to assay for the gene fusion product discussed nor the costs of testing for PCA3, which is currently commercially available.
Not Satisfactory
The story did not quantify the benefit of using these markers to avoid unnecessary biopsies. Typically, biopsy thresholds for the markers will be set to detect a large majority of the cancers (>= 90%) which will then reduce the number of unnecessary biopsies–which can be quantified.
Not Satisfactory
While alluding to problems with the PSA test, the story did not cover any potential problems that might arise with the experimental test. Although this test may potentially improve the accuracy of a man’s risk estimate, there was still a fair amount of overlap and uncertainity. The story did not report the proportions of cancers that were low and high risk. Finding a low risk cancer could be considered a harm because many are considered overdiagnosed. Missing a high risk cancer also causes harm.
This new test was suggested to eliminate the problem that arises because ‘it’s up to the patients and their doctors to figure out what to do next’ when an elevated PSA level is detected. However – even if this new test were available – it would still be up to patients and their doctors to determine what next steps to take.
Satisfactory
The story did a fair job explaining the study reported on, including mention that additional studies are necessary to validate the results of this study, larger groups of men need to be studied, and more diverse populations need to be tested in order to better estimate the utility of this test. However – the story does not report the PSA range of the men who where included in the study.
Satisfactory
The story did not engage in overt disease mongering.
Satisfactory
The story mentioned that the study reported on was funded by the company making the test; and it also mentioned that several of the authors of the study had financial interests in the company.
The story included quotes from a study author, as well as Dr. Jones from the Cleveland Clinic, though there was no mention of whether Dr. Jones had any financial interest in the test reported on.
Satisfactory
The story explains that “when PSA levels are elevated, it’s up to patients and their doctors to figure out what to do next” and that “There really aren’t very good tools to utilize to help make that decision.”
Satisfactory
The story indicated that the test was in development.
Satisfactory
If this approach were truly confirmed, it would be a novel and important advance, and the story appropriately addressed that potential.
Satisfactory
This story does not appear to rely solely on a news release.
Total Score: 7 of 10 Satisfactory
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