By Mark Scholz, MD
Studies designed to evaluate the effectiveness of surgery for prostate cancer take a long time to perform because prostate cancer grows much slower than other cancers. Since it is primarily in older men, mortality from unrelated causes—other cancers, heart disease and simply old age—frequently occurs before the prostate cancer progresses enough to impair health.
The first, very natural reaction to a diagnosis of prostate cancer is to cut it out!
However this thinking has been challenged because the type of operation necessary to excise the prostate is way more mutilating than what is typically needed to cure other cancers—at least half the men are rendered impotent and a quarter either leak or ejaculate urine.
Back in the late 1980s a group of medical researchers in Europe wanted to bring greater clarity to all the unanswered question related to how beneficial surgery is for prostate cancer. They proposed a clinical trial to evaluate the long term outcome of surgery compared to no treatment whatsoever. Throughout the 1990s they searched for study participants. In 1999, they finally had 695 men with prostate cancer who had volunteered to either undergo immediate surgery or to do nothing at all based on the outcome of a simple coin flip. Heads you do surgery. Tails you do nothing. The study coordinators designed the study with this coin-flip methodology to ensure that both groups had cancers of equal severity.
The average age of the participants in the study was 65; their average PSA was 13.
Eighty percent had a nodule on their prostate that could be felt on digital rectal exam. The study designers advised the physicians performing the clinical trial to withhold hormone therapy in their patients with progressive cancer until the cancer spread into the bones. Scans to detect bone metastases were only performed every other year.
The last participant to entering the trial had his operation in 1999. The whole group of 695 men was then watched for a period of 15 years. The results were reported in the New England Journal of Medicine showing that of the 347 men who had surgery, 81 (23%) developed bone metastases and 55 (16%) died of prostate cancer. Of the 348 men that had no treatment, 124 (36%) developed bone metastases and 81 (23%) died of prostate cancer.
The study coordinators reported that surgery resulted in impotence in 58% and incontinence occurred in 32%. One man died directly as a result of surgery. Hormone therapy after the development of cancer in the bone was initiated in 39% of the men who had undergone surgery and in 63% of the men who did not have surgery.
This study shows that surgery offers a small improvement (7%) in survival. There was, however, a larger improvement (24% reduction) in men requiring hormone therapy for bone metastases. These conclusions need to be interpreted in light of a couple of significant caveats:
1. The type of men in this study were rather more advanced in stage than what is typical for newly diagnosed men in the United States. According to the D’Amico stagingsystem they would be classified as “High-Risk”
2. The policy of delaying hormone therapy until after bone metastases is highly atypical in the United States. Treatment is usually initiated in men with steadily rising PSA levels prior to developing bone metastases.
Bottom line: This important study shows that surgery for “High-Risk” prostate cancer improves survival compared to no treatment at all. The amount of survival advantage (7%), however, is relatively small. The impact of surgery on reducing the future need for hormone therapy—a treatment with its own set of unpleasant side effects—is more substantial (24%).
My Thoughts: Ultimately, this study achieved its goal of bringing a better understanding of what surgery can and cannot achieve. Men with High-Risk disease should definitely consider doing some form of treatment; but perhaps not surgery. Radiation therapy, particularly seed implant radiation for example, has clearly been shown exceed surgical cure rates. The mortality rate of radiation is zero and the incidence of impotence and incontinence is greatly reduced compared to surgery.
About Dr. Scholz:
A board-certified medical oncologist, Mark C. Scholz, MD, serves as medical director of Prostate Oncology Specialists Inc. in Marina del Rey, CA, a medical practice exclusively focused on prostate cancer. He is also the Executive Director of the Prostate Cancer Research Institute. He received his medical degree from Creighton University in Omaha, NE. Dr. Scholz completed his Internal Medicine internship and Medical Oncology fellowship at University of Southern California Medical Center. He is the co-author of the book Invasion of the Prostate Snatchers: No More Unnecessary Biopsies, Radical Treatment or Loss of Potency. He is a strong advocate for patient empowerment.