When to consider active surveillance

Nancy Ferrari

Senior editor, Harvard Health

Increasing evidence suggests that men at low risk for cancer progression — including many of those with small tumors detected only through PSA screening — should consider a strategy of active surveillance rather than treatment. If you have just been diagnosed with early-stage prostate cancer and are debating the options, should you consider active surveillance?

The studies have produced mixed results, as explained in more detail below. But a 2005 review in the Journal of Oncology proposed a set of guidelines that may be helpful in designing a strategy of active surveillance. Table 1 below outlines the suggested parameters.

What the studies say

Clinical studies have been mixed about the health outcomes of men with early prostate cancer who adopt a strategy of active surveillance, as compared with men who choose other strategies. Unfortunately, this only further muddies the waters and makes it hard to provide clear guidelines for treatment. Several notable studies and their results are summarized below. (To find the studies themselves, see “For more information” below.) Further studies are under way that may help clarify whether it’s wise to opt for active surveillance.

The Scandinavian study

This study followed 223 men with early-stage cancer who did not seek treatment. At a 15-year follow-up, the men had health outcomes similar to a control group of men without prostate cancer. However, at a subsequent follow-up, researchers found that the men were more likely than the control group to die of prostate cancer 15–20 years after initial diagnosis.

The Connecticut Tumor Registry study

This study involved 767 men diagnosed with early-stage prostate cancer who either were not treated or underwent hormone therapy (not considered curative). Researchers found that men whose Gleason scores were between 2 and 4 were less likely to die of prostate cancer within 15 years — and even afterward — than those with higher Gleason scores.

The intensive lifestyle change study

This study involved 93 men diagnosed with early-stage prostate cancer who decided to forgo treatment; the men were randomly assigned to adopt lifestyle changes or to a control group. (The lifestyle changes included a vegan diet supplemented by vitamins and nutrients, regular exercise, stress reduction, and support group attendance.) Although the study did not look at survival, it did find that men who made lifestyle changes saw their PSA levels decrease by 4%, while PSA levels in men in the control group increased by 6% — a rough indicator of disease activity.

The Scandinavian Prostate Cancer Group study

Another Scandinavian study compared the long-term outcomes of radical prostatectomy with active surveillance. The study randomly assigned 695 men with early-stage prostate cancer to receive either surgery or active monitoring. Over all, surgery increased the chances of survival. By the time eight years had passed, for example, 8.6% of men who underwent surgery had died, compared to 14% of those involved in active surveillance. Although it is not clear whether the results are applicable to men whose cancers are detected through screening, this study has caused experts to urge caution when it comes to forgoing treatment.

The active surveillance algorithm study

Researchers at the University of Toronto developed a treatment algorithm in an effort to better differentiate men diagnosed with early-stage prostate cancer who can continue active surveillance from those who require intervention. The researchers used an algorithm that combined PSA doubling–time estimates and the results of follow-up biopsies (done 1, 4, 7, and 10 years after diagnosis) to determine whether treatment was necessary. The study involved 299 men diagnosed with localized prostate cancer who have been followed for eight years so far (the study is ongoing).

Most patients in the study (65%) continue active surveillance. Over all, 85% of the men remain alive, and most who have died succumbed to other causes; only 2 of the 299 have died of prostate cancer (a 99.3% disease-specific survival rate). The authors therefore propose that the combination of PSA monitoring and repeat biopsies may provide a way to determine who can continue active surveillance and who requires treatment. (For the algorithm, see Table 1.)

Table 1. Proposed guidelines for active surveillance

Eligibility guidelines
  • PSA no higher than 10 ng/ml
  • Gleason score no higher than 6
  • Tumor stage T1c to T2a
  • Life expectancy more than 15 years
  • Prostate biopsy finds cancer in no more than two core samples, and cancerous cells are present in less than half of each core
Monitoring guidelines
  • PSA test and digital rectal exam every three months for two years; if PSA level remains stable, every six months thereafter
  • Prostate biopsy (10–12 core samples) at one year; if no cancer, repeat biopsies every three years until age 80
Treatment should occur when
  • PSA level doubles in less than three years, on basis of eight PSA tests
  • Gleason score increases (7 or more)
Adapted with permission from Klotz L. Active Surveillance for Prostate Cancer: For Whom? Journal of Clinical Oncology 2005;23:8165–9, Table 2.

Benefits and risks of active surveillance

The chief benefit of active surveillance is that it allows you to avoid the possible side effects of treatment for early-stage prostate cancer. Some men also welcome the opportunity to buy time, as they wait for improved methods of detection or new treatment options.

The most significant risk of active surveillance is that your cancer was understaged — in spite of improved estimates made possible by mathematical calculations of risk, known as nomograms — and that without treatment it will continue growing and possibly even spread. In fact, probably one in four men who decide to opt for active surveillance will be advised to undergo treatment at some point during the surveillance period, on the basis of either PSA doubling or an increased Gleason score.

You should therefore consider the emotional and personal aspects of active surveillance. If you think you are likely to grow unduly anxious at the thought that cancer might be growing inside you, this strategy is not for you. On the other hand, if you are comfortable with the best mathematical predictions of risk we have available, and with monitoring your cancer through regular tests and biopsies, then this strategy may be the right choice.

It’s important to understand that active surveillance is just that — it requires multiple follow-up visits to your doctor, as well as multiple tests. As indicated above in Table 1, if you choose active surveillance, you will undergo frequent PSA testing and digital rectal exams, as well as repeat prostate biopsies.

On the other hand, medical technology is improving all the time, and you may soon have additional information to help you monitor your situation. In the next five years, for example, DNA microarray technology may make it possible for doctors to take a blood sample and analyze patterns in multiple genes to better assess the risk of your tumor’s growing and progressing.

For now, though, do yourself a favor if you are diagnosed with early-stage prostate cancer: At least discuss the possibility of active surveillance with your doctor. This is an option that deserves more attention. And if you decide to pursue treatment, carefully review all the options and risks.

For more information

Scandinavian study: Johansson JE, Andren O, Andersson SO, et al. Natural History of Early, Localized Prostate Cancer. Journal of the American Medical Association 2004;291:2713–9. PMID: 15187052.

Connecticut Tumor Registry study: Albertsen PC, Hanley JA, Fine J. 20-year Outcomes Following Conservative Management of Clinically Localized Prostate Cancer. Journal of the American Medical Association 2005;293:2095–2101. PMID: 15870412.

Intensive lifestyle change study: Ornish D, Weidner G, Fair WR, et al. Intensive Lifestyle Changes May Affect the Progression of Prostate Cancer. Journal of Urology 2005;174:1065–70. PMID: 16094059.

Scandinavian Prostate Cancer Group study: Bill-Axelson A, Holmberg L, Ruutu M, et al. Radical Prostatectomy Versus Watchful Waiting in Early Prostate Cancer. New England Journal of Medicine 2005;352:1977–84. PMID: 15888698.

Active surveillance algorithm study: Klotz L. Active Surveillance with Selective Delayed Intervention for Favorable Risk Prostate Cancer. Urological Oncology 2006;24:46–50. PMID: 16414494.

Originally published March 2009; last reviewed March 22, 2011.

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