Month 30 - Genetic Test & PSA Guidance

This will be a long post because there have been several important stories in the news about prostate cancer recently.

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The first report talks about a new genetic test that will better classify the aggressiveness of prostate cancer, and that will allow patients and their physicians to better guide their treatment decision.  This progress is quite exciting.

New Test May Help Guide Prostate Cancer Treatment 
(Full text below in case article gets deleted by NBC News.)

Being able to know the aggressiveness of the cancer may give men on active surveillance greater peace of mind, and it may allow those who are recently diagnosed to choose active surveillance as their treatment option, avoiding the potential risks of long-term, significant side effects that can come with radiation or surgery.

Of course, the test is new and unproven in the real world yet.  Still, it is a step in the right direction.

The second article talks about the American Urological Association's (AUA) change in guidelines concerning PSA testing, making the testing less frequent.

Urologists Recommend Less PSA Testing for Prostate Cancer
(Full text below in case article gets deleted by NPR.)

Funny that this article about PSA screenings would come out just before my next post-operative PSA screening (scheduled to get the results on 20 May).  I'll have to ask my urologist what his thoughts are on all this.

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What do I think about all of this?  Well, I'm glad that there is more and more research that is bringing the diagnosis and treatment of prostate cancer into better focus.  Don't get me wrong, I still think there's a long way to go, and if prostate cancer research had half the attention and support that breast cancer research does, we could make so much more progress at a more rapid pace.

What would I do if I were diagnosed with prostate cancer today given these and other recent developments in prostate cancer diagnosis, classification, and treatment?  Would I have skipped the radical prostatectomy?  I don't know.

What likely would have happened is that I would have slowed the decision-making process down to allow for more time for research and reflection.

When you hear "cancer" for the first time, your immediate response is to say, "Get rid of it!"  That's they way we've been conditioned all of our lives.  But now with these advances, we're getting to the point where the initial response can be, "Can I live with it?"  But it's going to take researchers and the medical community considerable time, effort, and facts to convince us that "Can I live with it?" should be the appropriate response.

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Pricey new test may help guide prostate cancer treatment

By MARILYNN MARCHIONE

updated 5/8/2013 9:55:14 AM ET 2013-05-08T13:55:14

A new genetic test to gauge the aggressiveness of prostate cancer may help tens of thousands of men each year decide whether they need to treat their cancer right away or can safely monitor it.
 

The new test, which goes on sale Wednesday, joins another one that recently came on the market. Both analyze multiple genes in a biopsy sample and give a score for aggressiveness, similar to tests used now for certain breast and colon cancers.
 

Doctors say tests like these have the potential to curb a major problem in cancer care — overtreatment. Prostate tumors usually grow so slowly they will never threaten a man's life, but some prove fatal and there is no reliable way now to tell which ones will. Treatment with surgery, radiation or hormone blockers isn't needed in most cases and can cause impotence or incontinence, yet most men are afraid to skip it.

"We're not giving patients enough information to make their decision," said Dr. Peter Carroll, chairman of urology at the University of California, San Francisco. "You can shop for a toaster" better than for prostate treatment, he said.

A study he led of the newest test — the Oncotype DX Genomic Prostate Score — is set for discussion Wednesday at an American Urological Association meeting in San Diego.

The results suggest the test could triple the number of men thought to be 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.

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. Only 10 percent who are candidates for monitoring choose it now.

"The question is, what's the magnitude of difference that would change the patient's mind?" said Dr. Bruce Roth, a cancer specialist at Washington University in St. Louis.

One man may view a 15 percent chance that his tumor is aggressive as low risk "but someone else might say, 'Oh my God, let's set the surgery up tomorrow,'" he said. "I don't think it's a slam dunk."

Also unknown: Will insurers pay for the expensive test without evidence it leads to better care or saves lives?

The newest test was developed by Genomic Health Inc., which has sold a similar one for breast cancer since 2004. Doctors at first were leery of it until studies in more groups of women proved its value, and the same may happen with the prostate test, said Dr. Len Lichtenfeld, the American Cancer Society's deputy chief medical officer.

The company will charge $3,820 for the prostate test and says it can save money by avoiding costlier, unnecessary treatment. Another test for assessing prostate cancer risk that came out last summer — Prolaris by Myriad Genetics Inc. — sells for $3,400.

Both companies can sell the tests without Food and Drug Administration approval under separate rules that govern lab diagnostics. Myriad Genetics has published nine studies on Prolaris involving more than 3,000 patients. Genomic Health has not published any results on the prostate test, another thing that makes doctors wary. Yet it has a track record from its breast cancer test.

About 240,000 men in the U.S. are diagnosed with prostate cancer each year, and about half are classified as low risk using current methods. 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.

"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.

For one study, researchers used prostates removed from 440 men. They measured the activity of hundreds of genes thought to be involved in whether the cancer spread beyond the prostate or proved fatal. A second study of biopsies from 167 patients narrowed it down to 81 genes, and researchers picked 17 that seemed to predict aggressiveness no matter the location in the tumor.

A third study used single needle-biopsy samples from 395 UCSF patients scheduled to have their prostates removed. The gene test accurately predicted the aggressiveness of their cancer once doctors were able to see the whole prostate after surgery.

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.

"It went both ways — that was the remarkable thing. In any category of risk it added independent information compared to the standard criteria we use today," Carroll said. "More work needs to be done, but, in my opinion, this is a very good start."

However, 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.

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.

Dean Smith, 60, a retired marketing executive from Mill Valley, Calif., is following his doctor's advice to monitor the cancer he was diagnosed with in March. He said a gene test may have made him more comfortable with that decision.

At least six of his friends suffered side effects ranging from urinary leakage to inability to have sex after having their prostates removed.

"I would suspect that having cancer and having to live with it would be very difficult for them," but it doesn't bother him, Smith said. "I will die from something other than prostate cancer, I guarantee you."



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Here's a link to the American Urological Association's latest guidelines for the detection of prostate cancer:

Detection of Prostate Cancer

(I've added a link to the AUA in the "Helpful Links" section, too.)

Urologists Recommend Less PSA Testing For Prostate Cancer

by Scott Hensley

May 03, 2013 2:49 PM

Terry Dyroff, of Silver Spring, Md., had a PSA blood test that led to a prostate biopsy. The biopsy found no cancer but did give him a life-threatening infection.

The men and women who often treat prostate cancer are now recommending that the blood test commonly used to screen for it should be given a lot less often.

The American Urological Association released new guidelines that, if they're heeded, would dramatically reduce the ranks of men who would be candidates for PSA testing.

The prostate-specific antigen test can catch cancer early, but it frequently gives false alarms or identifies cancers that don't require treatment.

So the urology specialists now say this about screening for prostate cancer:

• Men under 40 shouldn't get PSA tests. 

• Men ages 40 to 50 shouldn't be tested, if they're at average risk for the disease. Those at higher risk — such as African-American men and those with a family history of prostate cancer — should talk it over with their doctors. 

• For men 55 to 69, the test makes the most sense. The AUA panel recommends a shared decision by doctors and patient about the test. Once testing begins, the panel says it should be given every two years, rather than annually.

Finally, the group says men over 70 and with less than a 10 to 15 year life expectancy can probably skip the test.

Johns Hopkins urologist H. Ballentine Carter, chair of the guideline panel, acknowledged to USA Today that some men and doctors may be hesitant about less screening.

But the evidence reviewed by the panel supports the stance. PSA screening can prevent about 1 death from prostate cancer for every 1,000 men screened over a decade, the guideline says. But there are dangers from testing, including false positives and side effects from subsequent testing and treatment, including infections, impotence and incontinence.

"The public is very enthusiastic about screening, partly because of our messaging," Carter told USA Today. "The idea that screening delivers benefits may have been overexaggerated."

Almost a year ago the influential U.S. Preventive Services Task Force issued its own guideline saying healthy men should no longer get routine PSA tests.

The urologists disagreed then — and now. But the conversation has now shifted to how few men should get tested instead of how many.

Update at 3:55 p.m. ET: Dr. Otis Brawley, the American Cancer Society's chief medical officer, and a longstanding critic of PSA testing, praised the urology group's work in an email to Shots:

"I believe that the American Urological Association should be commended for a very careful evidentiary review and developing a statement that is truly consistent with the state of the science.

"The past 20 years represents some of the worst in public health in that we widely disseminated a screening intervention before adequately assessing it. I welcome any effort to explain to men the uncertainty, potential harms, and potential benefits of PSA screening. Use of this test should be a decision made by the individual patient in collaboration with his healthcare provider. The American Urological Association statement combined with the American College of Physicians statement of last month should mean the end of mass screening for prostate cancer.

"Now the American Cancer Society and five other independent organizations are calling for shared or informed decision making regarding use of this test."