What We've Learned From Active Surveillance
Begun 16 years ago, the Hopkins program has helped defi ne national recommendations for men who choose this approach

It's not right for everybody, but new data based on the pioneering Hopkins Active Surveillance program show that for some older men diagnosed with low-grade, lowvolume prostate cancer, careful monitoring is a safe approach. In fact, evidence from this program, begun by urologists H. Ballentine Carter, M.D., and Patrick C. Walsh, M.D., in 1995, is so strong that — based largely on the Hopkins results — the National Comprehensive Cancer Network has recommended this as the management of choice for a select group of men with very low-risk prostate cancer. In new guidelines, the Network recommends active surveillance for men with less than a 20-year life expectancy whose PSA, prostate biopsy results, and absence of palpable cancer on the digital rectal exam suggest that they have very low-risk disease.

"We began the active surveillance program at Johns Hopkins as a way of reducing unnecessary treatment for prostate cancer," says Carter. Over more than 16 years, nearly 1,000 men have been accepted into the program. A recent update of the Hopkins results, published in the Journal of Clinical Oncology, helps define some of the important considerations for men choosing this approach.

"Patients who are considering active surveillance are concerned about the longerterm risks of not getting treatment right away," says Carter. The main risk, he says, is that the biopsy has underestimated the true nature of the cancer by missing any higher-grade disease that might be lurking inside the prostate. This is why he places such importance on the yearly follow-up biopsy. "Based on the annual biopsies done in this program, we have now estimated this risk of fi nding a higher-grade cancer on a surveillance biopsy to be 4 percent per year."

Further, he explains, "since we know the long-term outcomes of men after treatment for high-grade cancer, and the rate that we will uncover a high-grade cancer among the men in our active surveillance program, we have shown that a 65-year-old man entering our program with very low-risk prostate cancer would have a one- to five-percent risk of dying from prostate cancer over 15 years."

But this information, Carter adds, is only one part of the very personal decision to pursue surveillance rather than immediate treatment — because each man is different, and needs to decide what is best for him and his family. "Men who are considering active surveillance need to weigh their ability to live with an untreated cancer against their preferences for avoiding the side effects of treatment, which can include urinary, bowel, and sexual dysfunction."

The Bottom Line

Eighty percent of the men in this program met all of our criteria for very low-risk disease," says urologist H. Ballentine Carter, M.D., a pioneer who has helped define this area of prostate cancer treatment.

Men eligible for the program have:
    • Cancer that cannot be palpated on a digital rectal exam (stage T1c);
    • A PSA density (PSA divided by prostate volume) of 0.15 or less;
    • Gleason score 6 or below;
    • No more than 2 biopsy cores with cancer, or more than half of any core with cancer.

Carter is convinced that vigilance is the key to the program's success. "These men undergo twice yearly blood testing and a digital rectal exam, and they get a yearly prostate biopsy to assess their cancer." Any change – if the cancer grows, or if the grade on the biopsy changes – triggers "curative intervention." Half of these men remain untreated after they have been in the program for six to seven years, and no patients in the program have developed distant metastatic disease or died of prostate cancer.

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