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New research from Canada and the US suggests that for certain prostate cancer patients, delaying treatment such as surgery or radiation therapy is a safe option as long as they are carefully monitored through "active surveillance" of biomarkers and biopsy samples.
The study was the work of first author Dr Scott Eggener, assistant professor of surgery at the University of Chicago Medical Center, and colleagues from other centres in the US and Canada, and is published in the April 2009 issue of the The Journal of Urology.
While active surveillance with delayed treatment is becoming more common as a way to manage low-risk prostate cancer, and many studies support this, there is still a need for evidence to back this up. This study looks more closely at the question of when to treat and when to keep observing.
Surgery and radiation therapy are effective treatments for prostate cancer, but they carry the risk of long term side effects that can seriously hamper a man's quality of life, including incontinence and erectile dysfunction.
As Eggener explained:
"When or if to treat men with low-risk prostate cancer has always been a challenging question that faces patients and urologists."
"Some men may be rushing into treatment that won't necessarily benefit them, prevent problems, or prolong life. Close observation in certain patients may provide and maintain quality of life without increasing the chances of the cancer spreading," he added.
There are no widely-accepted recommendations about which patients should have which option, and in the case of active surveillance, if and when a second or "restaging" biopsy should be done.
Eggener and colleagues suggest that a restaging biopsy (that is a second biopsy after the initial diagnostic biopsy) is the best way to ensure the short-term success of active surveillance because it gives doctors important information about the progress of the cancer.
Last year, many of the same researchers wrote a paper that showed for about 30 per cent of patients on active surveillance, the restaging biopsy showed they should no longer be kept on this "watchful waiting" strategy.
For the study, which took place between 1991 and 2007, Eggener and colleagues recruited 262 men from 4 medical centers in Canada and the US. They were all aged 75 and under, with PSA levels (prostate specific antigen, a blood biomarker for prostate cancer) of 10 ng/ml or less, whose cancers had not advanced beyond the T1-T2a stage and whose biopsy result showed a Gleason sum of 6 or less, plus other criteria that meant their cancer was not at an advanced stage and was progressing slowly.
The men all had a restaging biopsy and had no treatment for six months afterwards. The watchful waiting strategy after that was regular physical exams and PSA tests every 6 months, with further biopsies every 1 to 2 years.
Over a median follow up of 29 months, 43 participants elected to have treatment or, because there was evidence that their cancer was progressing, they followed their doctor's recommendation to have treatment. After such delayed treatment, all but one man was cured of their prostate cancer.
The remaining 219 patients stayed on active surveillance with no evidence of the cancer spreading.
The 2 and 5 year probabilities of staying on active surveillance were 91 and 75 per cent respectively. Patients with cancer on the second biopsy and a higher number of cancerous cores in the two biopsies combined were more likely to undergo treatment.
These figures were unaffected by age, PSA, clinical stage, prostate volume and number of total biopsy cores.
Eggener and colleagues concluded that:
"With a median followup of 29 months active surveillance for select patients appears to be safe and associated with a low risk of systemic progression."
" Cancer at restaging biopsy and a higher total number of cancerous cores are associated with a lower likelihood of remaining on active surveillance. A restaging biopsy should be strongly considered to finalize eligibility for active surveillance," they added.
Eggener emphasized that:
"Active surveillance is not a total disregard for patients with prostate cancer."
It identifies those men who are unlikely to be affected by their cancer, encourages them to undergo frequent monitoring, and then only having the therapy later, if it is needed.
"Cure rates appear to be identical when these men choose immediate treatment or delayed treatment when prompted by new information about their condition," he added.
The National Institutes of Health sponsored the study via the Ruth Kirchstein National Research Service Award.
"A Multi-Institutional Evaluation of Active Surveillance for Low Risk Prostate Cancer , 23 February 2009."
Scott E. Eggener, Alex Mueller, Ryan K. Berglund, Raj Ayyathurai, Cindy Soloway, Mark S. Soloway, Robert Abouassaly, Eric A. Klein, Steven J. Jones, Chris Zappavigna, Larry Goldenberg, Peter T. Scardino, James A. Eastham, Bertrand Guillonneau.
The Journal of Urology April 2009 (Vol. 181, Issue 4, Pages 1635-1641).
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