Active surveillance and watchful waiting in management of early stage (localized) prostate cancer

It is very important for newly diagnosed patients to understand that “watchful waiting” and “active surveillance” really are two appropriate (if similar) forms of management for early stage (localized) prostate cancer.  (You may also come across other terms that encompass both watchful waiting and active surveillance strategies, such as “expectant management.”)

For carefully selected men, one or other of these two forms of care may well be the very best possible management option. They come with a very low risk risk of side effects (for appropriate patients). They avoid all of the socially problematic and expensive aspects of treatment. Finally, if it turns out that the cancer is not particularly active, the result can often be that the patient easily outlives his risk of clinically significant prostate cancer.

The most critical problem with both active surveillance and watchful waiting is patient anxiety. Some men simply find it near to impossible to “live with” their cancer as opposed to getting it treated. That is an issue that only the individual patient can make decisions about in conjunction with his physicians and his family.

Patients who are interested in considering active surveillance or watchful waiting as first line options for the management of newly diagnosed prostate cancer should also read the section entitled “The downsides of conservative management.”

What Is “Watchful Waiting?”

Watchful waiting is best thought of as a “passive” form of prostate cancer management. It is accepted up front that there will be no attempt to eliminate the cancer and cure the patient.

In modern forms of watchful waiting, the doctor will carefully and regularly monitor potential indicators of disease progression by carrying out  PSA tests and DREs on the patient every 6 months or perhaps every year. Although there is a risk that the cancer will progress, and that it may become clinically active disease which might have been cured if the cancer had been removed when it was first found, on the other hand the quality of the patient’s life has been utterly unaffected by this form of treatment. The fundamental basis for modern forms of watchful waiting is that one is trying to avoid giving treatment of any type for as long as possible so that the patient may optimize his quality of life, while recognizing that it may be necessary in the long term to intervene late in the disease so that the patient has minimal impact from the potential morbidity and mortality associated with prostate cancer.

Just click here to watch a brief video presentation
about watchful waiting in the management of localized prostate cancer.

Watchful waiting is most commonly considered appropriate for older patients who, for one or more  reasons, a physician believes will be better served by avoiding curative treatments such as surgery or radiation. This may be because of their age, or because of concomitant health problems, or because the patient believes strongly that he would prefer the risk of disease progression to the risks associated with curative treatments.

It is also the case that watchful waiting is commonly more appropriate for men who have less aggressive forms of prostate cancer, usually of clinical stage T1c or T2a, a PSA of 10 ng/ml or less, and a Gleason score of 3 + 3 = 6 or 3 + 4 = 7.

Watchful waiting may also be appropriate for some men suspected of having localized disease but for whom a biopsy is perhaps an unnecessary intrusion because of their age or health. In other words, even if a biopsy proved to be positive, curative therapy would not be recommended, which makes the biopsy somewhat futile.

For some information about the effectiveness of watchful waiting compared to radical surgery (based on a single, large, randomized, multicenter Scandinavian trial), please click here.

What is “Active Surveillance?”

Active surveillance is best thought of as an “active” form of management. The goal is first to defer invasive treatment for as long as possible (so as to protect the patient’s quality of life for a long as possible) but to still be able to initiate treatment with curative intent when it becomes necessary.

There is no widely accepted, formal protocol for active surveillance (although we are getting a great deal closer to such a formal protocol), but it is customary for physicians to recommend a DRE and a PSA test every 3 or 6 months, depending on the patient’s precise history and clinical condition, to re-biopsy the patient at least once within the first year after initial diagnosis (preferably under some forms of MRI/TRUS fusion biopsy). Further biopsies are usually carried out as necessary over time (perhaps every two or three years) based on the clinical signs and symptoms of the individual patient. It is also becoming common at certain centers for the patient to be given an annual, multiparametric MRI scan to see if there are any reasons to initiate a repeat biopsy.

There is now an increasingly extensive quantity of data, published by a number of highly respected groups of physicians (including data from Johns Hopkins Medical Center, the University of California, San Francisco, and the University of Toronto) that provide with very high quality 10- and 15-year survival data for large numbers of patients in their active surveillance cohorts.

As indicated above, active surveillance in patients with early stage disease is intended to be carried out with curative intent. In other words, the physician monitors the patient aggressively and will regularly discuss disease status with the patient so that joint decisions are made about the need for actual treatment as opposed to just active surveillance. Thus, active surveillance for localized prostate cancer is somewhat similar to the management for a patient with signs of atypia, which is believed to be a precursor to early stage prostate cancer (at least in some patients).

Just click here to watch a brief video presentation
about active surveillance in the management of localized prostate cancer.

The great unknown with respect to active surveillance is, “How does one decide who is an appropriate candidate?”

Several different sets of criteria have been proposed over the past decade in order to offer guidance on who is eligible for active surveillance. The general rules that seem to be being relatively widely followed today are that a patient should have

  • Low risk disease, with a PSA of < 10 ng/ml, a Gleason score of 3 + 3 = 6, and a clinical stage of T1c or T2a
  • No positive biopsy core which is more than 50% positive for cancer

However, even the National Comprehensive Cancer Network is now suggesting that active surveillance may be entirely appropriate for some men who have

  • “Favorable” intermediate-risk disease, with a PSA of < 10 ng/ml, a Gleason score of 3 + 4 = 7, a clinical stage of T1c or T2a
  • Not more than one positive core containing any Gleason pattern 4 disease
  • A life expectancy of no more than 15 years

An on-line male prostate cancer life expectancy calculator on the Memorial Sloan-Kettering Cancer Center web site offers patients the opportunity to estimate their probability of dying from prostate cancer (as compared to dying of other causes) at 10 and 15 years post-diagnosis — if they are diagnosed with localized forms of prostate cancer that might be amenable to management on either watchful waiting or active surveillance

Regardless of whether a patient is being managed with active surveillance or watchful waiting, the critical question is always, “What do we do now?” if the patient’s disease does start to clearly progress.

If progression is slow, and the patient is elderly, it may be possible (and even wise) to do nothing for years, and the patient may still never have any clinical symptoms of prostate cancer that are affecting his life. On the other hand, there is evidence that in relatively young patients with a Gleason score of 3 + 3 = 6 or 3 + 4 = 7, and a life expectancy of 15 years or more, early treatment may well be beneficial unless there are clear reasons why it would be inappropriate. Watchful waiting and active surveillance are not generally recommended for such patients today (but there are certainly some younger patients who will go on active surveillance for significant periods of time before electing to have treatment).

It is not unknown for men to be on watchful waiting or active surveillance for very long periods of time, with a gradually rising PSA, until they clearly have advanced disease but no sign of metastasis and no bone pain. Even if they progress to the point where they do have bone pain and visible metastasis, they can be started on androgen deprivation therapy (ADT, also known as “hormone” therapy) of some type at that time. In such cases, they may avoid initial therapy for years and only need hormonal therapy for a relatively short period while still dying of causes other than prostate cancer in their late 80s or early 90s.

The very best evidence in support of watchful waiting and active surveillance has been published by Albertsen and his colleagues over several years, based on data from the Connecticut Tumor Registry. The two most important of these papers are probably their original report (published in 1998) and a follow-up paper published in 2005. In the first of these papers, Albertsen et al. showed that, among men diagnosed with prostate cancer between 55 and 74 years of age, and who only ever received hormone therapy:

  • Men with a Gleason score of < 5 have a risk of dying of prostate cancer within 15 years of between 4 and 7 percent (depending on their age at diagnosis)
  • Men with a Gleason score of 5 have a risk of dying of prostate cancer within 15 years of 6-11 percent (depending on their age at diagnosis)
  • Men with a Gleason score of 6 have a risk of dying of prostate cancer within 15 years of 18-30 percent (depending on their age at diagnosis)
  • Men with a Gleason score of 7 have a risk of dying of prostate cancer within 15 years of 42-70 percent (depending on their age at diagnosis)
  • Men with a Gleason score of 8-10 at diagnosis have a risk of dying from prostate cancer within 15 years of 60-87 percent (depending on their age at diagnosis)

So as to be clear, these data tell us nothing at all about men diagnosed at younger than 55 years of age.

In their follow-up paper published in 2005, Albertsen et al. basically showed that there was no significant change in the risk of death from prostate cancer based on Gleason score at the time of diagnosis at 20 years of follow-up.

In contrast, the very worst evidence is the fact that Willet Whitmore, MD, one of the strongest advocates for watchful waiting, and a highly respected urologic oncologist at what became the Memorial Sloan-Kettering Cancer Center in New York, died of prostate cancer himself at the age of 78 after practicing what he preached. However, it has to be said that we do not know Dr. Whitmore’s age, clinical stage, or Gleason score at diagnosis, which may, of course, be highly relevant.

Content on this page last reviewed and updated March 2, 2016.
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