Page 109 - An Evidence Review of Active Surveillance in Men With Localized Prostate Cancer

Observational Management Strategies with Unclear Treatment

Intent
Six cohorts reported followup protocols but did not report triggers for treatment of prostate
cancer, so it is unclear what observational management strategies were used to indicate the need
for treatments in those patients who did not receive initial treatments (Table 9). Various terms
were used to describe the observational management strategies in these cohorts, including “no
treatment,” “expectant management,” “watchful waiting,” and “active surveillance.” The
eligibility criteria and followup protocol of these cohorts were summarized in Tables 10 and 11.
None of these cohorts used parameters that have not been previously described.

Table 9. Cohorts that did not report triggers for treatment of prostate cancer
Country Center or Study Name
US Kansas City Veterans Affairs Hospital
University of North Carolina
Canada British Columbia Cancer Agency
Princess Margaret Hospital
Japan Kagawa Medical University (1990-1998)
Kitasato University Hospital

Summary

We identified 16 unique cohorts reporting formal protocols to monitor triggers for curative
treatment of prostate cancer. The eligibility criteria for patient selection and followup protocols
were heterogeneous.
Among these cohorts, the most commonly used parameter as part of patient eligibility criteria
was Gleason score (12 cohorts), no higher than Gleason 6 or 7. More recently, Gleason patterns
were also used in some of these AS cohorts, such as no higher than Gleason 3+3 or 3+4. All 16
cohorts enrolled only patients with clinical stages T2 or less and included regular PSA testing in
the followup protocol. PSA and Gleason score were the most commonly used parameters as part
of monitoring criteria for disease progression. Generally, progression in Gleason was defined as
a Gleason score or pattern greater than those used in the eligibility criteria for AS. Regularly
scheduled rebiopsy was also a common parameter in the AS followup protocol. Large variation
exists in terms of the definitions of disease progression, and the frequencies of AS monitoring
protocols.
In contrast to the above AS cohorts, less variability exists in terms of the definitions of
eligibility criteria for patient selection and followup protocols among the 13 cohorts of other
observational management strategies. All such cohorts used only symptomatic progression as
triggers for treatment; thus we labeled these observational management strategies as having
primarily palliative treatment intent. Regular bone scan schedule was commonly included in
these followup protocols. Rebiopsy was typically not used in these strategies; imaging tests were
more commonly used to track disease progression.
Implicit in the Key Question is a comparison between AS and other observational strategies
in the modern PSA era. Thus, we compared the 16 unique cohorts reporting formal protocols to
monitor triggers for curative treatment with the seven unique cohorts of other observational
strategies with primarily palliative intent in the PSA screening era. Enrollment into AS protocols
more commonly used Gleason score as a threshold than other observational strategies. They also
used the number and percentage of cores positive for cancer as a threshold while none of the

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