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documented the eligibility criteria for patient selection and followup protocols. We also extracted
triggers for recommending treatment and the definitions of prostate cancer progression
(Appendix Table C2.1). We considered studies reporting on observational
management strategies (i.e., no immediate active treatment with curative intent), enrolling
patients based on predefined eligibility criteria, and using prespecified protocols for followup.
We reviewed the full-text articles of all qualifying studies but only included the earliest
publication or the article with most complete information from the same center or research team
that used the same observational strategy (i.e., when the same definition was consistently used in
all publications). However, we also considered additional publications reporting on the same
cohort when they provided additional relevant information.
There is a broad spectrum of strategies for observational management described in research
publications. For the purpose of operationalizing the process of summarizing the various
definitions, we divided protocols into those clearly described as having curative intent and those
in which their aims were either unclear or primarily palliative, regardless of how these regimens
were labeled. This categorization was done for practical reasons, not to suggest what the
definitions or protocols for AS, WW, or any other observational strategy should be.
Due to often poor reporting of treatment intent, we based our interpretation on the specific
triggers used to initiate treatment in each study. Specifically, we operationally defined protocols
with curative intent as those that also used other parameters (with or without symptomatic
disease progression) as triggers for active treatment. Protocols where treatment was only initiated
upon symptomatic disease progression were considered as palliative.

Protocols With Curative Intent

We identified 16 unique cohorts reporting formal protocols to monitor triggers for curative
treatment of prostate cancer. Of these cohorts, ten are in the United States, two in Canada, two in
the UK, one in the Netherlands, and one in Japan (Table 1). In all cohorts, AS was offered to
men with low-risk or clinically localized prostate cancer although the eligibility criteria varied.
The protocols varied across all 16 cohorts. Baylor College of Medicine and Memorial Sloan-
Kettering Cancer Center were the first institutions to report enrollment of patients into AS
program in 1984.

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