Page 9 - An Evidence Review of Active Surveillance in Men With Localized Prostate Cancer

Key Question 4. What are the comparative short- and long-term outcomes of active
surveillance versus immediate treatment with curative intent for localized prostate
cancer? .................................................................................................................................... 75
Clinical Outcomes ............................................................................................................. 75
Costs .................................................................................................................................. 81
Summary ........................................................................................................................... 83
Key Question 5. What are the research needs regarding active surveillance (or watchful
waiting) in localized prostate cancer? ..................................................................................... 84
Key Question 1. Patient Population and Natural History Changes in Last 30 Years ....... 85
Key Question 2. Definition of Active Surveillance .......................................................... 86
Key Question 3. Factors That Affect Offer of, Acceptance of, and Adherence to AS ..... 87
Key Question 4. Active Surveillance Versus Immediate Curative Treatment ................. 88
Discussion..................................................................................................................................... 90
References .................................................................................................................................... 93
Abbreviations and Acronyms .................................................................................................. 106

Tables
Table 1. Unique AS Cohorts ......................................................................................................... 31
Table 2. Cohorts That Used Gleason Score and PSA as Part of Patient Eligibility Criteria
for AS ............................................................................................................................................ 33
Table 3. Eligibility Criteria for Enrollment in Protocols With Curative Intent in Chronological
Order of Starting Enrollment Year ............................................................................................... 34
Table 4. Cohorts That Used PSA (ng/mL) or PSA Kinetics as Part of Followup Protocol
for AS ............................................................................................................................................ 40
Table 5. Monitoring Criteria in Protocols With Curative Intent in Chronological Order
of Starting Enrollment Year .......................................................................................................... 41
Table 6. Unique 13 Cohorts of Observational Management Strategies With Palliative Intent .... 47
Table 7. Eligibility Criteria for Enrollment in Protocols With Palliative Intent in Chronological
Order of Starting Enrollment Year ............................................................................................... 50
Table 8. Monitoring Criteria in Protocols of Observational Management Strategies
With Palliative Intent in Chronological Order of Starting Enrollment Year ................................ 53
Table 9. Cohorts That Did Not Report Triggers for Treatment of Prostate Cancer ..................... 58
Table 10. Protocols That Did Not Report Information on Triggers for Intervention
in Chronological Order of Starting Enrollment Year ................................................................... 60
Table 11. Monitoring Parameters in Cohorts That Did Not Report Information on Triggers
for Intervention in Chronological Order of Starting Enrollment Year ......................................... 61

Figures
Figure A. Analytic Framework That Depicts the Five Key Questions (KQs) That Examine
the Role of Active Surveillance in the Management of Men With Clinically Localized Prostate
Cancer ....................................................................................................................................... ES-5
Figure 1. Analytic Framework That Depicts the Five Key Questions (KQs) That Examine
the Role of Active Surveillance in the Management of Men With Clinically Localized Prostate
Cancer ............................................................................................................................................. 6
Figure 2. Literature Flow .............................................................................................................. 16
Figure 3. Years Covered and Databases Utilized by Studies Considered Eligible for Key
Question 1 ..................................................................................................................................... 19

ix