Page 25 - An Evidence Review of Active Surveillance in Men With Localized Prostate Cancer
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Eligibility Criteria
The six cohorts that enrolled patients in the pre-PSA screening era primarily based
enrollment on clinical staging alone. In the PSA era, the seven cohorts mostly enrolled patients
with stage T1 or T2 cancer or without evidence of nodes or metastases. The commonly used
patient eligibility criteria were PSA (5 cohorts), age (4 cohorts), Gleason score (4 cohorts), and
normal bone scan findings (4 cohorts).
Age
Four cohorts included age as part of their eligibility criteria. The different thresholds used
were less than 75 years (2 cohorts), less than 85 years, and between 50 and 75 years.
Gleason Score
Four cohorts used Gleason score thresholds. Three used a threshold of less than 8. One
required that less than 25 percent of the tumor was Gleason grade 4 and less than 5 percent grade
5.
Number of Cores Positive for Cancer
No cohort used this factor.
Percentage Cancer Involvement in Each Core
No cohort used this factor.
Prostate-Specific Antigen
Five cohorts used PSA as part of their eligibility criteria, with thresholds of less than
50 ng/mL (4 cohorts) and less than or equal to 15 ng/mL (1 cohort).
Imaging
Four cohorts required normal bone scan findings. One of these cohorts also required normal
chest radiograph findings.
Behavioral Indications
No cohort used this factor.
Followup Protocols
Five of the six cohorts in the pre-PSA screening era included regular prostate acid
phosphatase (PAP) testing and bone scan in the followup protocol. The sixth cohort reported
regular PSA and DRE in the followup protocol for patients who received no treatment after the
introduction of PSA in 1990. All seven cohorts in the PSA screening era included regular PSA
testing. Compared with AS cohorts (see previous section), rebiopsy was not commonly included
in the followup protocol among WW cohorts.
Gleason Score
No cohort used this factor.
Number of Cores Positive for Cancer
No cohort used this factor.
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