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A test that changes prostate cancer treatment recommendations — but does it improve outcomes?

Rating

3 Star

Tags

New Study Published on Cover of Urology Finds that Decipher® Prostate Cancer Classifier Reduces Conflicting Treatment Recommendations between Urologists and Radiation Oncologists

Our Review Summary

prostate cancerIn this news release, we’re introduced to a world of confusion among doctors about what to do with a man after they remove his cancerous, walnut-sized prostate gland. And the release offers something that can allegedly reduce that confusion: GenomeDx Biosciences’ Decipher, a test that sniffs out 22 different genetic signals of how a cancer case might play out.

Next we’re told about the struggle between urologists and radiation oncologists. The former group is less likely than the latter to prescribe “adjuvant therapy,” typically radiation, after removing a prostate gland. Missing high-risk cancer cases and not treating them is a problem, of course, but so is treating men who probably don’t need it. (Although we’re never really told why that’s an issue.)

According to the release, Decipher has the ability to change the minds of both urologists (45%) and radiation oncologists (35%), and get more of them to agree what or what not to do with a patient after removal of his cancerous prostate gland. That’s potentially an important advance, but we aren’t provided with crucial context — notably that it’s unclear if the decisions made because of Decipher were actually better decisions that would lead to a reduction in prostate cancer deaths. We’re also never cautioned about the small size of the study, given cost information about the test, or told about potential harms.

 

Why This Matters

Among cancers in men, prostate cancer is the second-most common – about 1 in 5 men in the U.S. will get a diagnosis in their lifetimes. It’s also the second-most deadly: Of the more than 200,000 men diagnosed each year in the U.S., nearly 30,000 die. (At least twice as many more black men succumb to prostate cancer as other ethnic groups.)

Testing prostate cancer for how likely it is to grow quickly and migrate (metastasize) might save a lot of men from unnecessary follow-up treatments and unwanted side effects. So, a reliable tool to help clinicians make informed choices – and with a consensus of opinion among the doctors a patient sees – stands to help everyone while reducing costs associated with prostate cancer.

Criteria

Does the news release adequately discuss the costs of the intervention?

Not Satisfactory

There isn’t a dollar sign in this release, and we could find no reliable figure for how much each Decipher test costs. (A New York Times article suggests similar genomic tests for prostate cancer cost roughly $3,000, if not more.) We’ve reached out to the company’s PR agency for an average per-test cost, but haven’t received a response in time for the publication of this review.

Does the news release adequately quantify the benefits of the treatment/test/product/procedure?

Satisfactory

The release states that, according to the latest study, Decipher has the ability to change the minds of both urologists (45%) and radiation oncologists (35%), and get more of them to agree what or what not to do with a patient after removal of his cancerous prostate gland.

We’ll give the release credit here for quantifying the main findings of the study. But we’d note that there was potential to go deeper. We’re never told how many patients have issues with recurrent cancer or metastasis. (The Centers for Medicare and Medicaid Services suggests about 40,000 men each year face a high risk.) We also aren’t told how effective radiation or other therapies are after a prostatectomy, nor how effective Decipher might be in saving lives. Most of the clinical trials cited in the article mention only reductions in biochemical progression–a surrogate endpoint.

Most of what’s found in the release are rather general statements from doctors who have financial relationships with GenomeDx Biosciences, e.g. “it helped ensure that the ones selected for adjuvant therapy are the ones most likely to benefit from it.”

Does the news release adequately explain/quantify the harms of the intervention?

Not Satisfactory

The release doesn’t explain what sorts of risks a patient faces from radiation, hormone, and other “adjuvant” therapies after surgery, and avoiding these seems to be a key point of the Decipher test. We also don’t get any words on how reliable the test actually test is and how often it might return inaccurate results, which is its own kind of risk.

Does the news release seem to grasp the quality of the evidence?

Not Satisfactory

The release lacked context on important study limitations, particularly the small sample size of clinicians (only 20 urologists and 26 radiation oncologists) and the small number of patient cases (only 11). We also don’t know how experienced/representative the clinicians are in their specialties, or whether results among academics differed from community practices.

The study comments on some of this in its conclusion section, and it would have helped to see something like it in the release: “The sample size of this study is modest, and so additional validation studies are needed to determine the generalizability of the results over a wide range of patient cases and clinicians with varying degrees of expertise.”

Does the news release commit disease-mongering?

Satisfactory

There’s nothing dramatic or overblown in this release.

Does the news release identify funding sources & disclose conflicts of interest?

Not Satisfactory

GenomeDx Biosciences funded the research. The company’s name appears 14 times in the release and its product shows up 29 times.

But while the study itself makes detailed and explicit disclosures about funding and potential conflicts of interest (some of the researchers are employees of the company), the news release doesn’t. That’s unfortunate. Prostate cancer is very prevalent, Medicare can cover the cost of a Decipher test, and about half of men who get prostate cancer are covered by Medicare — so GenomeDx Biosciences has a lot to gain from more widespread use of its product.

Does the news release compare the new approach with existing alternatives?

Not Satisfactory

We’re not told if there are any alternatives. Even if Decipher stands alone as a post-operative test, that’s critical information.

In the study itself, the authors did provide clinicians with information about risk groups, PSA, and extensive information about the pathology of the cancer. Studies (and guidelines) have used these parameters to guide treatment–it would be useful to know whether the initial decisions followed accepted practice. If not, then clinician education might be a more (cost) effective intervention than providing results from an expensive test.

Does the news release establish the availability of the treatment/test/product/procedure?

Satisfactory

We’re told Decipher is commercially available and that Medicare can pay for the test.

Does the news release establish the true novelty of the approach?

Satisfactory

A bit of boilerplate text toward the end of the release gets at novelty with this statement: “Decipher generates a risk result that is completely independent and distinct from PSA, Gleason score and other clinical risk factors. Clinical studies from leading cancer centers published in over a dozen medical journals demonstrate that Decipher can accurately predict metastatic disease, which men may benefit from radiation therapy following prostate surgery, and can lead to significant cost-savings for healthcare systems.” That’s good enough for Satisfactory rating, although we caution again that the amount of independent value added from Decipher is unclear.

Does the news release include unjustifiable, sensational language, including in the quotes of researchers?

Satisfactory

We found no charged or dramatic language. On the contrary, the entire release is pretty staid.

Total Score: 5 of 10 Satisfactory

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