Cancer Outcomes with Androgen Deprivation Therapy for Localized
& Advanced Prostate Cancer
Date Submitted: July 23, 2004
Objectives:
To characterize the clinical outcomes and their predictors in patients who were treated
with primary androgen deprivation for clinically localized prostate cancer and for
advanced prostate cancer. This work will be done in parallel with and in collaboration
with an analysis of quality of life outcomes in the same population led by Dr. Potosky.
Rationale:
Recent studies indicate increasing use of androgen deprivation (AD) as primary therapy for
localized prostate cancer[1]. The cancer outcomes have not been well characterized in
this setting. There is a growing awareness of the long-term morbidity associated with
androgen deprivation and the implications of this approach for overall quality of life are
not well defined.
Data:
Subjects eligible for this analysis will need to have completed the 6 and/or 12 month
questionnaire and the 24 and/or 60 month questionnaire. Included are subjects diagnosed
with either cT1-2, N0, M0 adenocarcinoma of the prostate or more advanced stages of
prostate cancer and who started AD therapy within 1 year of diagnosis as their first
therapy for prostate cancer. Outcome variables and covariates will be determined from
questionnaires and medical record abstracts done in 1999 and 2002.
Methods:
All analyses will be performed using Statistical Analysis of Correlated Data (SUDAAN). A
stratified random sampling with replacement and the Horvitz-Thompson weight will be used
to obtain unbiased estimate of the proportion and regression parameters. The primary
endpoints are: PSA failure (confirmed with 2 rising PSAs), PSA nadir, local failure,
distant failure, and cardiovascular complications, depression and treatment for
depression, overall survival. Initially the analysis will be performed separately for
local and advanced diseases. If the same factors are predictive, a stratified analysis
will be performed to estimate the risk pooled across the strata (i.e., disease stage).
Depending on available data, a Cox proportional hazard regression model and/or logistic
regression model will be employed to identify a set of independent risk factors.
Dissemination:
Results will be submitted to a peer-reviewed journal.
Target Schedule:
Analyses to begin: October 2004
First draft completed: March 2005
Draft submitted: July 2005
Collaborators:
Tomasz Beer (lead), Motomi Mori, Mark Garzotto, David Penson, Arnold Potosky
Contact Information:
Tomasz M. Beer, M.D.
Oregon Health & Science University
3181 SW Sam Jackson Park Road
Mail-Code: CR-145
Portland, OR 97239
Phone: (503) 494-0365
E-mail: beert@ohsu.edu
1. Cooperberg MR, Grossfeld GD, Lubeck DP, Carroll PR.
National practice patterns and time trends in androgen ablation for localized prostate cancer.
J Natl Cancer Inst 2003;95(13):981-9.
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