Page 105 - An Evidence Review of Active Surveillance in Men With Localized Prostate Cancer

Table 8. Monitoring criteria in protocols of observational management strategies with palliative intent in chronological order of starting
enrollment year (continued)
Center, Monitoring PSA Gleason # biopsy cores Imaging Behavioral Additional Triggers for interventions
Country schedule score /% cores indication laboratory
[Pubmed ID] tests
Enrollment
years
Royal Marsden Every 6 mo PSA √ – – – – – Symptomatic prostate cancer
Hospital, UK 112 and DRE progression
[15839912]

1993-2002
PIVOT, US 146 Every 6 mo PSA √ – – Bone scan – – Discouraged treatment for
[18783735] every 5 yr asymptomatic progression
(eg, per PSA)
1994-2002
Watchful Every 3 mo PSA √ – – – – – Developing progressive
Waiting Study, disease
US 147
[14501381]

1998-2003
Hospitals in Every 6 mo PSA >50 – – All patients – – Hormonal manipulation was
Manchester, underwent demanded by the protocol
UK 148 “multiple bone when the PSA rose to 50
[11711356] scans” (all ng/mL.
negative),
NR
Univ. of Florida, Every 3 mo PSA √ – – – – – Cancer progresses or
US 149 and DRE; symptoms become imminent.
[18263992] Repeat biopsy
about 6 mo after
2003-2006 the initial
diagnosis.
WW = watchful waiting; EM = expectant management; NR = not reported; DT = doubling time; mo = month(s); PAP = prostate acid phosphatase; PSA = prostate specific antigen;
TRUS = Transrectal ultrasound; CT = computerized tomography; PSA = prostate-specific antigen; TNM = tumor-node-metastasis system; US = ultrasound; yr = year(s); ED =
erectile dysfunction; SPCG-4 = Scandinavian Prostate Cancer Group Study Number 4; PIVOT = Prostate Cancer Intervention Versus Observation Trial; VA = Veterans Affairs
√ = item was used as part of monitoring strategy but explicit criteria were not defined
– = item was not used or not reported as part of monitoring strategy
a Local progression was defined as a palpable transcapsular tumor growth; symptoms of obstruction of the flow of urine that necessitated intervention, or both.
b Local progression was defined as symptoms (subjective), increase in T category, increase in prostate size on DRE by 25%, or increase in ultrasound measured volume >40%.

55