How Risky is Active Surveillance?

At Hopkins, the answer to the question in the headline is “not very.” This is because, ever since 1995, when H. Ballentine Carter, M.D., Patrick C. Walsh, M.D., and others began this program, the byword has been ultra-vigilance. Haunted by the similarsounding philosophy of “watchful waiting” — promoted for years in Europe, it is as unlike what the Hopkins program is all about as night from day — the Brady urologists have bent over backwards working to make sure the program is as safe as can be.

Watchful waiting means, “sitting by and doing nothing until a man has symptoms and his cancer has spread beyond the curable point, then giving hormonal therapy and palliative treatment.” and nobody at Hopkins thinks that’s a good idea. Active surveillance, or “expectant management,” is only possible because so much research in recent years — most of it done at Hopkins — has given doctors the tools to keep a very close watch on a man’s cancer, so that at the least sign that it has changed, they can treat it with surgery or radiation when it is still curable.

If there’s a risk, why wait? Why not get that cancer out right away? Immediate treatment is certainly a good option, and many men choose it because they want the peace of mind, and don’t want to live with any uncertainty.

Today, many men are diagnosed
with prostate cancer at such
an early stage that immediate
treatment is not necessary. This
is why active surveillance is an
option for some men.

The downside is that they put themselves through treatment that has side effects, a recovery time, the risk of impotence and a small risk of incontinence.

And here’s the kicker: They may not even need it. Today, many men are detected at such an early stage that immediate treatment is not necessary. This is why active surveillance is an option for some men. “An ideal candidate,” explains Carter, “is 65 years or older, and has a cancer with a very low risk of causing harm without treatment, based on prostate biopsy findings and a PSA history.” Although the cancer appears to be slow-growing, the doctors don’t rely on assumptions; patients in the program undergo a digital rectal examination and PSA test every six months, and a follow-up biopsy once a year. (For more on the importance of the yearly biopsy, see story.)

About 800 men have been enrolled in the program over the last 15 years. In a recent study of 376 of these men, Carter and colleagues found that, at an average of six years after they entered the program, the cancer did progress in about 33 percent of these men, and treatment was recommended. Using the results of this study, the scientists were able to stratify men — who already were considered at very low risk of having their cancer progress — into risk categories:

  • If a man’s free PSA is greater than 15 percent and cancer is found in less than 35 percent of any biopsy core when he is diagnosed, his risk of reclassification (to a higher stage of cancer) at the first follow-up biopsy a year later is 8 percent.

  • However, if a man’s free PSA is less than 15 percent and cancer is found in 35 percent or more of any biopsy core at diagnosis, his risk of reclassification at the first follow-up biopsy is 29 percent.

“Furthermore, we were able to predict a man’s probability of reclassification at four years after he enters the program using PSA density (PSAD , the ratio of PSA to prostate volume), and whether or not cancer is found on the first follow-up biopsy,” Carter says. “For example, if a man’s PSAD is below 0.08 and there was no cancer found on the first surveillance biopsy, his risk of reclassification four years after entering the program is 11 percent. On the other hand, if a man has a PSAD of 0.08 or higher, and his first followup biopsy shows very low-risk cancer that would not have prompted treatment, his risk of reclassification is 54 percent.

Thus, Carter adds, “finding any cancer on the first follow-up biopsy, coupled with PSAD , was predictive of the future risk of reclassification and a recommendation for treatment in this program.” These findings were published in the Journal of Urology. “We believe this information could help individual patients make decisions about whether or not surveillance is right for them.”

The Bottom Line:

The risk of cancer progression is higher if any cancer is found on the first follow-up biopsy, and a man’s PSA density is 0.08 or higher.

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