Page 93 - An Evidence Review of Active Surveillance in Men With Localized Prostate Cancer

Age. Four cohorts (5 publications) reported age as part of patient eligibility criteria. 144-147,150 The
age criterion was less than 75 years in the WW arm in SPCG-4 (Scandinavian Prostate Cancer
Group Study Number 4) 144 and PIVOT (Prostate Cancer Intervention Versus
Observation Trial), 146 and less than 85 years in the Watchful Waiting Study. 147 One cohort at
Erasmus University hospital enrolled patients from the European Randomized Study of
Screening for Prostate Cancer (ERSPC). 145,150 The ERSPC-screening protocol was carried over
to become part of the patient selection criteria for this cohort, which required patients’ age to be
between 50 and 75 years old. 151

Gleason score. Four cohorts (5 publications) used the Gleason score as part of patient eligibility
criteria. 112,144,145,147,150 The Gleason score criterion was less than 8 in three cohorts. 112,145,147,150
The SPCG-4 cohort reported that “patients whose condition was diagnosed with an extended
biopsy protocol were accepted if less than 25 percent of the tumor was Gleason grade 4 and less
than 5 percent grade 5.” 144

Number of cores positive for cancer. None of the 13 unique cohorts used number of cores
positive for cancer as part of patient eligibility criteria.

Percentage cancer involvement in each core. None of the 13 unique cohorts used percent
cancer involvement in each core as part of patient eligibility criteria.

Prostate specific antigen. Five cohorts (6 publications) used PSA threshold as part of patient
eligibility criteria. 144-148,150 Two criteria were used: PSA less than 50 ng/mL (4 cohorts) 144,146-148
and less than or equal to 15 ng/mL (1 cohort). 145,150

Imaging. Four cohorts (5 publications) required normal bone scan findings as part of patient
eligibility criteria. 144-146,148,150 One cohort also required patients to have normal chest radiograph
findings to be eligible for the observational management program. 145,150

Behavioral indicators. No behavioral indicator was used explicitly as a criterion for patient
enrollment in the 13 unique cohorts.

Followup Protocols of Observational Management Strategies with
Palliative Intent (Table 8)
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. 138-142 The sixth cohort
reported regular PSA and DRE in the followup protocol for patients who received no treatment
143
after the introduction of PSA in 1990. No information regarding the followup protocol in the
pre-PSA screening era was provided. The monitoring frequency varied across these six cohorts
(Figure 6).
All seven cohorts (8 publications) in the PSA screening era included regular PSA
testing. 112,144-150 The monitoring frequency varied across the cohorts (Figure 6). Compared with
AS cohorts (see previous section), rebiopsy was not commonly included in the followup protocol
among WW cohorts.

48