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Table 8. Monitoring criteria in protocols of observational management strategies with palliative intent in chronological order of starting
 enrollment year

 Center,   Monitoring schedule   PSA   Gleason   # biopsy   Imaging   Behavioral   Additional   Triggers for interventions
 Country   score   cores /%   indication   laboratory
 [Pubmed ID]   cores                  tests
 Enrollment
 years
 Howard   Every 3 mo for the first 5   √   –   –   Annual bone   –   PAP   Signs and/or symptoms of
 University   yr, every 4-6 mo   (after   scan; CT of the   disease activity.
 College of   thereafter. Assessment   1985)   pelvis was used
 Medicine,   included DRE, PAP and   infrequently
 US 138    since 1985 a PSA was
 [1600492]   done.

 1967-1989
 Orebro Medical   Every 6-12 mo clinical   √ (in   –   –   Bone scan   –   PAP   Patients were treated
 Center,   exam, PAP, and bone   the last               hormonally if disease
 Sweden 139    scans. PSA only   few yr)                progressed for they had
 [7933233]   performed in the last few                  symptoms of progression.
    yr
 1977-1984
 Northern   Every 3 to 6 mo for the   –   –   –   Bone scan every   –   PAP   Treatment was offered if
 Stockholm,   first 2 yr and every 6 to   12 to 18 mo   clinical progression with
 Sweden 140    12 mo thereafter with                    symptoms
 [17467883]   DRE and PAP; annual
    rebiopsies during the first
 1978-1982   4 yr
 Freeman   NR (“Disease   –   –   –   6-monthly bone   –   Acid and   No treatment until
 hospital, UK 141    progression was   scans (after   alkaline   symptomatic progression.
 [3191340]   monitored”)   1983)      phosphatase

 1978-1985
 Western   Every 3 mo   –   –   –   Chest X-rays,   –   √   Progression of disease
 General   skeletal X-rays                              (i.e., development of
 Hospital, UK 142    and bone scans                     metastases (M1) or
 [8343901]   every 6 mo                                 elevation of PAP to > 2 u/l)
                                                        and/or development of
 1978-1990                                              symptoms.













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