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Gene test may help guide prostate cancer treatment


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Gene test may help guide prostate cancer treatment

Our Review Summary

The story employed very careful presentation of both the promise and the potential limitations of two new prostate cancer gene tests.

Until recently, the PSA test was routinely used as a screening instrument for prostate cancer resulting in millions of men suddenly facing a set of interesting choices.  If the PSA is elevated, should a biopsy be performed?  If so, how reliable is the Gleason scoring system in predicting the risk of spread and death? Because of uncertainty, many men undergo potentially needless surgical procedures rather than perhaps watchful waiting.  A new and potentially more reliable test to determine the aggressiveness of the tumor type in concert with a Gleason score or as a replacement would be welcomed.  A reliable predictive test of risk of death from prostate cancer would add considerably to the decision process.


Why This Matters

One line from the story captures the essence of why this matters:

“Doctors say tests like these have the potential to curb a major problem in cancer care — overtreatment.”


Does the story adequately discuss the costs of the intervention?


The cost of the new test – and of one that recently came on the market – were listed (> $3,000 each). And the story explained it’s not known if insurers will pay for the tests.

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


The story carefully framed the potential benefits – “could triple the number of men thought to e at such low risk for aggressive disease that monitoring is a clearly safe option.  Conversely, the test also suggested some tumors were more aggressive than doctors had believed.”

It explained that one manufacturer had published 9 studies while the other had not published any results yet – “another thing that makes doctors wary.”

It explained that in one study:

“Using one current method, 37 of the 395 men would have been called very low risk and good candidates for monitoring. Adding the gene test put 100 men into that category, said another study leader, Dr. Matthew Cooperberg of UCSF. The gene test shifted about half of the men into either a lower or a higher risk category.”

Does the story adequately explain/quantify the harms of the intervention?


The story explained some of the potential limitations of the new testing approach.

“Unless you can be sure your biopsy has hit the most aggressive part that’s in the prostate, you can’t be sure” how accurate your risk estimate is, explained Dr. Eric Klein, chief of urology at the Cleveland Clinic, who led early development of the Oncotype prostate cancer test.

UCSF just got a federal grant to see how men choose treatments and whether this test might sway them.

“We throw all these numbers at them. Are they really going to make a better decision?” Cooperberg said.

Does the story seem to grasp the quality of the evidence?


The story carefully explained:

Independent experts say such a test is desperately needed but that it’s unclear how much information this one adds or whether it will be enough to persuade men with low-risk tumors to forgo treatment, and treat it only if it gets worse.

Genomic Health has not published any results on the prostate test, another thing that makes doctors wary.

Dr. Kevin McVary, chairman of urology at Southern Illinois University School of Medicine and a spokesman for the Urological Association, said the test must be validated in more men before it can be widely used.

“It’s not there yet,” he said.

But wouldn’t it be most helpful to report what the sensitivity and specificity of the test was?

Does the story commit disease-mongering?


There was no disease mongering of prostate cancer in the story.

Does the story use independent sources and identify conflicts of interest?


Mixed bag.

Multiple sources were interviewed – which was admirable.

The story could have explained that two of the experts quoted either had paid consultant arrangements or received research funding from one of the companies mentioned in the story.

Does the story compare the new approach with existing alternatives?


We’ll give the story the benefit of the doubt on this one.  It covered a lot of ground and we don’t want to ding it for what it might have done a bit better.

It at least gave data comparing one of the new tests with “one current method.”

It at least said the new test is “similar to tests used now for certain breast and colon cancers.”

And it at least reported that “Doctors now base risk estimates on factors such as a man’s age and how aggressive cells look from biopsies that give 12 to 14 tissue samples. But tumors often are spread out and vary from one spot to the other.”

Does the story establish the availability of the treatment/test/product/procedure?


The story explained that one test goes on sale today and that another recently came on the market. And it raised the questions about whether availability/use will be limited if there isn’t evidence it leads to better care or saves lives.

Does the story establish the true novelty of the approach?


The story put the new test – set for discussion today at the American Urological Association annual conference – into the context of some other relatively new genetic tests for cancer.

Does the story appear to rely solely or largely on a news release?


Lots of independent reporting so it’s clear this story didn’t rely on a news release.

Total Score: 10 of 10 Satisfactory

Comments (3)

Please note, comments are no longer published through this website. All previously made comments are still archived and available for viewing through select posts.

Richard Hoffman

May 8, 2013 at 3:41 pm

The issue is that men with low PSA and Gleason scores on biopsy are considered candidates for active surveillance–a monitoring strategy where men are not offered active treatment unless there is evidence that the cancer is progressing. The big concern is that biopsy results might not accurately capture tumor aggressiveness due to sampling errors. The new tests are comparing biopsy results against prostatectomy findings to determine whether risk can be more accurately characterized from the biopsy tissue alone. However, it is important to note that we do not know whether these new tests can accurately predict the risk of dying from prostate cancer.


Gary Schwitzer

May 9, 2013 at 1:58 pm

See Dr. Len Lichtenfeld’s post on the American Cancer Society website, “A New Genomic Test To Guide Prostate Cancer Treatment: What We Know And What We Don’t.”

He concludes:

“This might be a fantastic test. It might be the answer we are looking for when it comes to telling us what we need to know about patients who appear to have low risk prostate cancer and would be candidates for active surveillance or watchful waiting. But let’s have the data so we can make the interpretation before we blast the media and the web with all sorts of testimonials that boot strap limited studies to grand promises. Diagnostic tests and treatments that are not subject to critical review have a tendency to become self-fulfilling, such as the enthusiasm generated for robotic surgery. And based on some comments in some of the press reports, including the one referenced above, some experts agree with a cautious approach. However, those are not the comments that appear to make the headlines.

As my colleague Dr. Otis Brawley – who is the Chief Medical Officer of the American Cancer Society–said to me recently, faith based medicine is not evidence based medicine. After what we have been through with prostate cancer, we should have learned our lesson to demand the evidence before we demand the test.”


John Ludlow MD

May 24, 2014 at 8:25 pm

A test to more accurately identify those with prostate cancer who NEED treatment would be welcome. The real problem is our fee-for-service healthcare system. I’m incentivized to biopsy patients with ‘elevated’ PSAs…whether they need it or not. And to make matters worse, none of what I do is tabulated for outcomes. This makes no sense. I could easily biopsy 20 patients every week and truthfully only 1 or 2 of those patients really need a biopsy. In the end, the validity of this genetic test will be confirmed by long-term (greater than 10 years) follow-up.