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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