The End of “Surgery is the Gold Standard”

Prostate surgery study published in NEJM

Ten years ago surgery was considered the “” treatment for prostate cancer, the treatment to which every other treatment should be compared.  Now we are hearing the Gold Standard claims being used less and less. What has led to this change?

The primary cause is a study published in the New England Journal of Medicine by Dr. Timothy Wilt. In the early 1990s, Dr. Wilt and a group of expert researchers proposed an “acid test” of surgery’s cure rates to measure the survival of men treated with surgery and compare it with men receiving no immediate treatment whatsoever.

  After much discussion the study was commenced in 1994.  To make the comparison totally unbiased, individuals volunteering for the study had to be willing to do surgery or observation based solely on the flip of a coin—heads for surgery and tails for no treatment.  If they chose to participate in the study they would have to forgo any personal preference they might have for one treatment over the other and simply comply with the result of the coin flip.

Over the next eight years, starting in 1994 and ending in 2002, five thousand men were invited to participate in the study. It’s hardly surprising that such a large number of men had to be asked.  As would be expected, the majority refused to participate.  Ultimately 731 men agreed to enter the study and have their treatment determined by the flip of a coin, half receiving surgery and the other half monitored without treatment. The profile of these volunteers was fairly typical of men with the disease; their average age was 67 and the median PSA level for the whole group was 7.8.


After ten years of monitoring (after either undergoing immediate surgery or receiving no treatment) the overall prostate cancer mortality rate in the two groups was within the expected range of statistical variation for two similar-sized groups  that were treated in an identical fashion—5.8% died in the surgery group and 8.4% died in the observation group.

  However, in an analysis of a subgroup of men whose PSA levels were above 10, the men who had surgery showed a slight but real improvement in survival—only 5.5% died in the surgery group whereas 12.8% died in the observation group.

This study not only demonstrated surgery does not prolong life in men with a low PSA level; it also clearly illustrates how different types of prostate cancer behave differently. These patterns of disease behavior have not been overlooked by certain prostate cancer experts such as Anthony V. D’Amico, MD, PhD, Professor of Radiation Oncology at Harvard Medical School.  Dr. DAmico is credited with developing the modern staging system that divides men into low, intermediate and high risk categories based on whether an individual’s PSA level is less than 10, 10 to 20, or over 20, along with other identifiable factors such as the Gleason score—less than 7. 7, or over 7.  

So when the outcomes of all patients, whether they had surgery or not, was reassessed in light of their D’Amico risk category, i.e., low, intermediate or high, it became apparent that surgery only improved survival in men with high risk disease.

  Men with low risk disease have no improvement in survival with surgery and therefore can be safely monitored without immediate treatment.  The study reported that men in the intermediate risk category showed no improvement in survival with surgery.  However, there was a 10% lower incidence of metastases suggesting perhaps that some men with intermediate risk disease can derive some benefit from surgery.

This study is a landmark study in the world of prostate cancer. It provides a quantifiable measure of the degree of benefit associated with immediate surgery in men with intermediate and high risk disease.  It’s hardly surprising that this study has changed the way people think and why the old “Surgery is the Gold Standard” argument is rapidly falling out of favor.

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