Closely monitoring low-risk prostate cancer, with biopsy, does not raise risk of death

A Johns Hopkins study of 769 men from across the United States recently diagnosed with low-grade prostate cancer shows that forgoing immediate surgery to remove the tumor or radiation poses no added risk of death. Delaying treatment is fine, the results show, so long as the cancer's progression and tumor growth are closely monitored through "active surveillance" and there is no dramatic worsening of the disease over time.

None of the men, mostly 65 and older, have so far died from prostate cancer since the study began in 1995. However, one-third of study participants, monitored for as long as 15 years, eventually underwent treatment, primarily because annual biopsy results showed more cancer.

The study, to be published in the Journal of Clinical Oncology and posted online ahead of print, is believed to be the largest and longest study of men initially diagnosed with a slow-growing, very nonaggressive form of prostate cancer. This means they stand very little chance of dying from the disease, which was classified as very low risk, in its earliest stage, called T1c.

"This study offers the most conclusive evidence to date that active surveillance may be the preferred option for the vast majority of older men diagnosed with a very low-grade or small-volume form of prostate cancer," says study senior investigator and urologist H. Ballentine Carter, M.D. "These are men with a favorable risk disease profile to begin with."

Carter, director of adult urology at The Johns Hopkins Hospital and a professor at the Johns Hopkins University School of Medicine and its Brady Urological Institute, acknowledges that "for some of these men, the prospect of living with prostate cancer is unbearable, and the tumor has to go." But, he adds, "the vast majority of these men are ideal candidates for active surveillance because they are older and are able to avoid the risks and complications associated with surgery and radiation." The best candidates for surveillance programs, he says, are those who can be relied on to keep their medical appointments.

Some 217,000 men in the United States are diagnosed each year with prostate cancer, the majority of them older than 65, and with a low risk of dying from the disease if treatment is deferred, Carter says. Yet, more than 90 percent of these men with low-risk disease, including some 80 percent of those over 75, are likely to choose some form of treatment instead of surveillance.

"Our findings really underscore the need to address excessive treatment of this milder stage of the disease in older men, especially seniors," says Carter.

Possible complications from surgery or radiation to treat tumors, he says, primarily include incontinence, and other bowel, urinary or sexual problems.

Just as significantly, Carter and his team notes, their study highlights the importance of carefully selecting patients who are least likely to benefit from treatment.