Page 351 - An Evidence Review of Active Surveillance in Men With Localized Prostate Cancer

Appendix Table C2.1. Eligibility criteria, follow-up protocols, triggers for intervention and definition of progression in cohorts of active
surveillance/ watchful waiting/other observational management strategies (continued)

Center, Country Eligibility criteria Followup or monitoring protocol Triggers for intervention/ Definition of
[PMID] active therapy progression
Enrollment year
Freeman hospital, Patients without Disease progression was monitored by history, physical exam, No treatment until NR
UK 141 symptoms after TRUS for T staging and prostate volume since 1983, serum symptomatic progression.
[3191340] initial outflow acid and alkaline phosphatase and 6-monthly isotope bone
tract surgery or scans.
1978-1985 biopsy.
Hospitals in “Localized” (bone Patients were followed-up at 6-month intervals. All patients Hormonal manipulation was Bone scan for
Manchester, UK 148 scan-negative) underwent “multiple bone scans” (all negative), and hormonal demanded by the protocol metastases; PSA
[11711356] prostate cancer manipulation was demanded by the protocol when the PSA when the PSA rose to 50 levels.
patients treated rose to 50 ng/mL. DRE not always performed in patient with ng/mL.
NR by watchful- long-standing, stable PSA values.
waiting. All
patients had
PSA level < 50
ng/mL
Howard University Stage A and B 3-mo intervals for the first 5 yr, then at 4 to 6-mo intervals Management plan of watchful NR
College of prostate cancer thereafter. Each visit assessment included DRE, pap and waiting for most patients
Medicine, US 138 patients who since 1985 a PSA was done. until signs and/or
[1600492] were in a Bone scans were done initially and annually thereafter. CT of symptoms of disease
prospective the pelvis was used infrequently, primarily in patients who activity occurred.
1967-1989 expectant elected not to have any form of surgical therapy. Any progressive changes in
management enzymatic activity and/or
program. signs or symptoms of
progression or metastasis
(back pains or weight loss),
or changes in rectal
findings either by DRE or
TRUS were treated despite
evidence of a positive or
progression of the bone
scan.

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