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2014 AUA Annual Meeting, 4Kscore, OPKO Health, Video

New Prostate Cancer Tests a 'Positive Work in Progress' ( http://www.medscape.com/viewarticle/826331 )

June 16, 2014 Gerald Chodak, MD

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Video Link ( http://www.medscape.com/viewarticle/826331 )

Hello. I am Dr. Gerald Chodak, for Medscape.

One of the dominant themes at this year's American Urological Association annual meeting was the use of genetic and other biomarker tests to try to risk-stratify patients in terms of whether they should undergo biopsy -- and if they have a biopsy, whether they should be treated for their prostate cancer. After all, one of the major concerns about screening is that many men undergo a biopsy that turns out to be negative, whereas other men are found to have prostate cancer ( http://emedicine.medscape.com/article/1967731-overview?src=wgt_edit_news_lsm&lc=int_mb_1001 ) that is not life-threatening, yet they end up being treated.

One way to shift this paradigm is to be able to say to some men, "You do not need a biopsy because your likelihood of cancer is very low," and to other men who are found to have prostate cancer, "Your risk from the disease is very low, and we can reassure you that active surveillance is a reasonable and safe way to proceed."

I attended many of the booths and listened to many of the presentations, and my best assessment is that progress has clearly been made in this area. It is not a perfect paradigm yet -- not a perfect situation, but the data[1,2] continue to accumulate showing how to use these tests and the proportion of men who may be able to avoid a biopsy or a treatment without risking false-negatives in too many men.

Yes, there will be a trade-off. Some men who are told that their risk of having a serious cancer is low will indeed have a serious cancer. There will be a miss rate of false-negatives. On the other hand, the tests will also tell some men that their risk of ultimately having cancer or ultimately getting into trouble from their cancer may be higher than they were told in the first place.

The data we have are being presented in a way that makes it hard to evaluate the real outcome. What we would like to know is, if we take 100 men and test or do not test them, how many are better off as a result? What is the net difference? Some of the data being presented are showing just that: the numbers of men who are changing their minds about whether to have a biopsy or whether to undergo treatment for their cancers.

But going forward, we need those data in real time, as well as the long-term outcomes, to be able to see exactly what we get.

What Are the Downsides?

Currently, a lot of the available tests are not reimbursed by many insurance companies, and some of the tests are quite expensive. We will need some way to determine whether the cost is worth it, or possibly the insurance companies will change their reimbursement philosophies and make it easier for men to be tested.

We have to be careful that this does not represent another test that ends up costing people and society a lot of money without making a real difference in decision-making. At the end of the day, I do believe that we are moving in a good direction -- that tumors that are dangerous do contain genes and express genes that can be measured, and they can be identified so we can tell people whether or not they need to be treated or whether conservative therapy is a safe way to go.

We recognize that in the United States, active surveillance is not accepted by a great number of the men who indeed are eligible on the basis of the criteria we have available. These additional tests may improve our ability to make men more willing to accept a conservative approach.

I am encouraged by what I am seeing. I think we still need more data to help understand the overall net benefit and clinical utility, but it is a positive work in progress -- and ultimately, I believe it will make a difference in helping a lot of men get what they need in terms of either a biopsy or a treatment.

I look forward to your comments. Thank you.

References

1. Cuzick J, Stone S, Yang, ZH, et al. Validation of a 46-gene cell cycle progression (CCP) RNA signature for predicting prostate cancer death in a conservatively managed watchful waiting needle biopsy cohort. Program and abstracts of the American Urological Association Annual Meeting; May 16-21, 2014; Orlando, Florida. Abstract MP79-17.
2. Lin D, McGee S, Rieger-Christ K, et al. The 4KScore test ( http://4kscore.opko.com/ ) as a predictor of high-grade prostate cancer on biopsy. Program and abstracts of the American Urological Association Annual Meeting; May 16-21, 2014; Orlando, Florida. Abstract PI-06 ( http://opkodd.files.wordpress.com/2014/04/vol-191-no-4s-supplement-sunday-may-18-2014.pdf ) .