New guidelines support active surveillance as first choice for many with prostate cancer

If you're like a lot of men who receive a diagnosis of prostate cancer, your first instinct is to begin aggressive treatment right away. But if you are at low or very low risk for developing advanced prostate cancer without treatment, don't be surprised if your doctor recommends doing what seems to be nothing.

In fact, new guidelines from the National Comprehensive Cancer Network (NCCN) support this idea. The NCCN (an alliance of 21 leading cancer centers throughout the country) recommends that for many men, no treatment—at least initially—may be the best option of all. The term for this management strategy is active surveillance.

Once considered to be just one of several options for men with low-risk prostate cancer, active surveillance is now usually the preferred treatment option for older men in the low- to very-low-risk category, depending on life expectancy.

What Is Active Surveillance?

Active surveillance means that you forgo immediate treatment for your prostate cancer, instead choosing to see your doctor regularly to check for disease progression. Follow-up plans differ depending upon the physician and center. However, most involve at least a digital rectal examination (DRE) and prostate-specific antigen (PSA) test at three- to six-month intervals and prostate biopsies at regular intervals (once a year or more frequently). If there are signs that your disease has progressed, you and your doctor would then pursue a definitive treatment option—radical prostatectomy, external beam radiation therapy or brachytherapy.

Disease progression has been defined by most physicians as a Gleason grade of 4 or 5 on repeat biopsy (or any Gleason score of 7 or more), prostate cancer that is found in more biopsy cores than in the initial biopsy or that occupies a greater extent of the biopsy cores, or a PSA doubling time of less than three years (not all physicians use PSA doubling time as a criterion for progression, however).

An Important Distinction

In the past, watchful waiting was a strategy of avoiding treatment when men were diagnosed with advanced disease and treatments were more likely to cause serious adverse effects than they are today. At the time, watchful waiting interventions were palliative in nature—that is, intended to limit pain and complications.

By comparison, active surveillance is a management strategy for the current era, when overtreatment of prostate cancer is common. The goal of active surveillance is selective intervention to cure the disease for those men whose disease progresses.

Are You a Candidate?

Active surveillance is usually appropriate for men with very low-risk prostate cancer whose estimated life expectancy is less than 20 years. Prostate cancer experts at Johns Hopkins consider a man to be at very low risk if he has

  • a stage T1c (PSA detected) tumor
  • Gleason score (the sum of your primary and secondary Gleason grades) of 6 or below
  • prostate cancer in no more than two biopsy cores with cancer present in 50% or less of any core
  • PSA density (PSA divided by prostate volume on ultrasound) below 0.15 ng/mL/cc

Active surveillance is also usually appropriate for men with low-risk prostate cancer whose estimated life expectancy is less than 10 years. You are at low risk if you have a stage T1c or T2a tumor, Gleason score of 6 or below and a PSA level less than 10 ng/mL. If you are at low risk but are expected to live more than 10 years, radical prostatectomy, radiotherapy and active surveillance should all be considered as management options.

Why Do Nothing When You Could Do Something?

Many prostate cancers behave in an indolent fashion for many years and will never cause problems—even without treatment. In fact, it is estimated that 30 to 50 percent of men over age 60 whose prostate cancer was discovered through PSA screening would never have known they had the condition had their PSA results not triggered a biopsy. In addition, studies have shown that older men are also much more likely to die of causes other than prostate cancer.

Data from these and other studies support the contention that aggressively treating all men with very low- to low-risk cancers would unnecessarily subject many of them to serious side effects, such as erectile dysfunction, urinary incontinence, and bowel damage.

A growing body of data from active surveillance studies supports this as well. For example, a recent study in the Journal of the American Medical Association reported a 10-year cancer-specific survival rate of 94 percent among men age 65 and older with low-risk prostate cancer who were treated with active surveillance. Similarly, a 2010 Canadian study following 450 men with low- to intermediate-risk prostate cancer who were under active surveillance for a median of nearly seven years reported a 10-year prostate cancer-specific survival rate of 97 percent.

Research also shows that in men with very low-risk to low-risk prostate cancers, waiting until the tumor progresses before initiating definitive treatment does not appear to increase the chances that the tumor will progress to an untreatable stage.

Investigators at Johns Hopkins recently reported on the outcomes of 772 men with PSA-detected prostate cancer who chose active surveillance. At a follow-up of two years, 116 of the men had a radical prostatectomy (delayed intervention group), 43 because their follow-up biopsy revealed a higher-grade, more aggressive cancer. The investigators compared the surgical pathology results from these men with the results from 348 men who qualified for active surveillance but chose radical prostatectomy rather than active surveillance as their initial treatment (immediate intervention group).

They found that pathology results at surgery were similar for men in the delayed and immediate groups when follow-up biopsies among those in the delayed group did not show any high-grade cancer. However, for the men whose follow-up biopsies showed high-grade cancer, surgical pathology results indicated more advanced disease among those who delayed surgery as compared with those who underwent immediate surgery. The investigators suspect that these men had high-grade tumors that were not detected on their initial biopsy. Among men in the Johns Hopkins surveillance program, there was a 4 percent rate of finding high-grade cancers on annual surveillance biopsies.

As these findings demonstrate, adequate biopsy sampling is crucial. That is why experts at Johns Hopkins recommend that before beginning active surveillance, men should have a repeat 12- to 14-core biopsy to confirm that more extensive or higher-grade disease is not present when their initial biopsy removed less than 12 cores of tissue.

Guidelines for Follow-Up

Regular follow-up is crucial for men who choose active surveillance. The NCCN recommends the following schedule, although guidelines may vary from institution to institution:

  • total and free PSA testing every three to six months (free PSA predicts the aggressiveness of prostate cancer)
  • digital rectal exam (DRE) every six to 12 months
  • prostate biopsy within six months of the diagnosis if the initial biopsy obtained less than 10 cores or within 18 months if 10 or more cores were obtained

At Johns Hopkins, an annual surveillance biopsy also is recommended. Data from Hopkins and other centers show that cancer may progress in some men even though there is little change in their PSA levels.

Before You Decide

Before you decide to choose active surveillance, it's important to consider your emotional tolerance level. For example, will you be able to live indefinitely with an untreated cancer without excessive worry? Another question to ask: Will you be able to stick to the recommended surveillance schedule?

If the honest answer to either question is no, do not be afraid to tell your doctor. Only then will you be able to determine the best course of treatment for you.

Publication Review By: H. Ballentine Carter, M.D.

Published: 21 Jun 2011

Last Modified: 01 Jul 2011