Page 146 - An Evidence Review of Active Surveillance in Men With Localized Prostate Cancer

Definitive conclusions for men with low-risk disease on AS or WW versus RP or RT will
have to await results from two ongoing trials: Prostate cancer Intervention Versus Observation
a
Trial (PIVOT: observation vs. RP ) and Prostate Testing for Cancer and Treatment trial
b
(ProtecT: AS vs. RP or RT ). PIVOT recruited 731 patients (364 randomized to RP, 367 to
observation); initial results were presented in the 2011 American Urological Association annual
meeting (webcasts.prous.com/AUA2011/html/1-en/template.aspx?section=7&p=7,18082#).
ProtecT has finished recruitment (>2500 men, about 700 men each were offered AS, RP, or RT)
c
and is now in the followup phase. A brief description of these studies is provided in Appendix
Table B.
Although cost calculations using retrospective data were performed using different methods
and followup durations in each study, overall it appears that WW is associated with lower
treatment costs compared with active treatment. However, a cost analysis based on the ICER
model indicates that with long-term followup, the costs of AS may exceed those of RP and BT;
and may be lower than those of intensity modulated RT (IMRT) or proton beam RT.
Limitations in our approaches in this report largely concern the breadth of literature covered.
For example, studies identified for the question on factors relevant to the practice of AS were
primarily found from our literature search conducted specifically for AS, we did not do a general
search on specific topics like insurance or patient compliance. Undoubtedly, there are studies on
some of these factors in patients with other cancers and their findings could potentially be
informative here.
In conclusion, more men are being diagnosed with early stage prostate cancer. Whether
active monitoring with a curative intent is an appropriate option for these men remains unclear.
A standard, universally agreed-upon definition of AS that clearly distinguishes it from WW and
other observational management strategies is needed to help clarify scientific discourse in this
field. Ongoing clinical trials may provide information on the comparative effectiveness of AS
compared to immediate active treatment, but will require long term followup.

a Available at http://clinicaltrials.gov/ct2/show/study/NCT00007644; last accessed September 30, 2011.
b Available at http://clinicaltrials.gov/ct2/show/NCT00632983; last accessed September 30, 2011.
c See http://www.epi.bris.ac.uk/protect/pdffiles/newsletters/ProtecT%20Newsletter%20No8%20Dec%202010.pdf;
last accessed September 30, 2011.

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