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103 Issue 6 Interview Transcript

Kristine Crane: Welcome to the JNCI podcast. I'm Kristine Crane. PSA velocity, or how quickly a man's PSA level rises, has been a frequent measure for prostate cancer screening. But a recent JNCI study, led by Dr. Andrew Vickers at Memorial Sloan-Kettering Cancer in New York, concludes that PSA velocity is not a useful measure. It may, in fact, lead to a large number of unnecessary biopsies. The study also recommends that PSA velocity be taken off the guidelines of the National Comprehensive Cancer Network. I talked with Dr. Otis Brawley, the chief medical officer of the American Cancer Society about this study. So what did the Vicker study on prostrate velocity find?

Otis Brawley: The Vicker study took men from the prostate cancer prevention trial who were actually in the placebo arm. And this is the best-screened group of men ever in the history of prostate cancer screening, median age about 62 at the start of the trial, 69 at the end of the trial. And what they did was, they looked at this thing that we have commonly done, and we have done with very little evidence that it's effective, and that is change in prostate cancer over-- I'm sorry, change in PSA over time to see if it predicts for prostate cancer. And they ultimately decided the change in PSA over time really was not very effective in diagnosing prostate cancer, or finding men who might have prostate cancer.

Kristine Crane: Now this was in men, though, who did not have other potential indicators of a risk for prostate cancer, so do you think that PSA velocity might be useful for other men?

Otis Brawley: Actually, you know, you ask the question very well. One of the problems in medicine, especially in prostate cancer medicine, is so frequently we have done things because we thought it was a good idea, and we haven't put those ideas to test to see if they really are good ideas. And so I'm hesitant to, at this juncture, say that there's any usefulness for change in PSA over time. I would agree with the Vickers paper that number one, people need to realize there's a question mark as to whether prostate cancer screening and early detection is appropriate for prostate cancer. If people do believe early detection is appropriate perhaps they need to use a lower set point for PSA for biopsy as opposed to looking at PSA over time.

Kristine Crane: Do you have any recommendation for what that level might be?

Otis Brawley: There is no such thing as a safe PSA. This same group of men in previous studies have generated prostate cancers that were quite significant clinically when men had a PSA of 0.6 or 0.8. Two-point-five might very well be a reasonable level to start thinking about a biopsy, again, if you're truly interested in early detection and you've decided that screening actually is an appropriate thing for that particular gentleman.

Kristine Crane: So I would imagine that you agree with Vickers' conclusion that PSA velocity in any case should not be part of the National Comprehensive Cancer Network guidelines?

Otis Brawley: I think PSA velocity has been disproven by this study. This is the only study that's ever looked at it. Some people might argue that maybe we ought to do a second study, that's going to be very, very difficult to do. I think that if we have a guideline, the guideline really ought to state what is proven in terms of studies, and then what is opinion. It might be reasonable for a guideline to say it is the opinion of experts despite a prospective randomized trial. But I don't want to get in the-- I don't want to tell NCCN what they should be saying, but I think that a guideline needs to reflect what the scientific literature says, and the strength of that scientific literature.

Kristine Crane: So if a man's PSA level is rising relatively quickly, or by a lot, what might that be indicative of?

Otis Brawley: Prostatitis, benign prostatic hyperplasia, a prostate infarct, even a change in certain exercise routines can cause a rise in PSA. Also, by the way, prostate-- there are such things as stones in prostate ducts that can cause an elevation of PSA in addition to prostate cancer and prostatic intraepithelial neoplasia. So I think that men who want to be screened and want to follow their PSA should continue to follow their PSA, but should realize that there are a lot of things that cause elevation in PSA.

Kristine Crane: And what would be a level of change that would be worth watching for?

Otis Brawley: Well, what has been shown in a number of studies is that doctors didn't really have a definite set point for level of rise to trigger a biopsy. The NCCN has recommended .35 per year, others have used a PSA change of one in one year. So if one went from, say, .6 to 1.7, that would have triggered the change. There's been a lot of variability across the country, and there's no group of individuals or group of experts have come to a definite, good, this is what a PSA change should be. The most common probably was NCCN at .35 per year.

Kristine Crane: And just going back to PSA level in general as a measure which was long perceived as a gold standard but in recent years has been a lot more controversial, where do you stand in that whole controversy?

Otis Brawley: Well, first I think every man needs to know that there is a controversy. I am very concerned that I hear a lot of advertisements on the radio on TV. Even I hear news reporters and doctors in interviews that either don't understand that there's a controversy, or they downplay the fact that we really don't know if screening saves lives. Sometimes they do it because they just don't understand the depth of the controversy. Sometimes there are some folks who push prostate screening because it's a great money maker for hospitals, unfortunately. Here in Atlanta we've even had one group of physicians giving out free tickets to basketball games, to professional basketball games, to lure people in to get screened. The NCCN, the American Neurological Association, the European Neurological Association, and my own American Cancer Society, while we say it differently, all four organizations say that men should be informed before they're screened, that there is a controversy. There are questions about the efficacy of prostate cancer screening. And we all say that men who then want to be screened should be screened. Men who don't want to be screened should not be criticized for it. So I'm a true believer in informed decision making without any kind of efforts to try to sway, cajole, or dupe a man to do something that he's uncomfortable with.

Kristine Crane: The Vickers study, you probably noticed it get a lot of press coverage, so that could be a positive thing.

Otis Brawley: One of the reasons why the Vickers study got a lot of positive press coverage is, there have been a number of lawsuits over the last 15 years because doctors did not use change in PSA over time to trigger a biopsy. This is one of the great concerns that I have. Not only do some doctors do things for which we do not have science to support, but they're doing these things for which we do not have science to support, have actually become the community standard so that doctors who are more conservative and more orthodox, and actually practicing a much more scientific evidence-based brand of medicine, become actually subject to lawsuit because they practice evidence-based medicine.

Kristine Crane: Do you have anything else to add?

Otis Brawley: No, I think that this was incredibly good science, well-constructed. This is evidence that we need more studies to show-- I'm sorry, we need more studies to actually look at prostate cancer in a very scientific way as this study did. And I would hope that the community of patients, and survivors, and doctors would all come together and support doing good science like this.

Kristine Crane: That was Dr. Otis Brawley, the chief medical officer of the American Cancer Society. For more information on this podcast or for a transcript, or to listen to more JNCI podcasts, please visit our Web site at www.jnci.org. You can also follow us on Twitter at jnci_now. I'm Kristine Crane. Thank you for listening.

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