Design considerations for efficient prostate cancer chemoprevention trials

Citation
Jd. Lee et al., Design considerations for efficient prostate cancer chemoprevention trials, UROLOGY, 57(4A), 2001, pp. 205-212
Citations number
45
Language
INGLESE
art.tipo
Article
Categorie Soggetti
Urology & Nephrology
Journal title
UROLOGY
ISSN journal
0090-4295 → ACNP
Volume
57
Issue
4A
Year of publication
2001
Supplement
S
Pages
205 - 212
Database
ISI
SICI code
0090-4295(200104)57:4A<205:DCFEPC>2.0.ZU;2-U
Abstract
Prostate cancer, even with its substantial public health impact of 180,400 new cases and 31,900 deaths estimated for 2000, still has a very low annual incidence (0.27% for men 34.4 years and older), which makes designing and conducting efficient prostate cancer prevention trials a challenge. Definit ive prevention trials with cancer endpoints, such as the Breast Cancer Prev ention Trial (BCPT), Prostate Cancer Prevention Trial (PCPT), and Selenium and Vitamin E Cancer Prevention Trial (SELECT), require long trial duration (up to 12 years) and large sample size (up to 32,400 subjects) to accompli sh their objectives. This article discusses design concepts for potential p rostate cancer prevention trials that require fewer years, subjects, and re sources to complete. Design elements, such as high-risk populations, random ization, surrogate endpoints, including quality-of-life endpoints, masking/ blinding, and various clinical/statistical designs (including 1-way layout, all-versus-none, factorial, and adaptive designs), are discussed, along wi th the ultimate goal of gaining US Food and Drug Administration approval fo r prostate-cancer preventive agents that can improve ea public health by re ducing prostate cancer incidence and mortality.