Statistical design issues and other practical considerations for conducting phase III prostate cancer prevention trials

Journal of Urology

Volumn 171, Issue 2 II, 2004, Pages

  Tangen, Catherine M ^a,c   Goodman, Phyllis J ^a   Crowley, John J ^a   Thompson, Ian M ^b  

^a Fred Hutchinson Cancer Research Center   (United States)

^b UNIVERSITY OF TEXAS HEALTH SCIENCE CENTER AT SAN ANTONIO   (United States)

^c NONE   (United States)

Author keywords

Phase iii clinical trials; Prostatic neoplasms; Surrogate endpoint

Indexed keywords

ALPHA TOCOPHEROL; FINASTERIDE; SELENIUM;

ANTINEOPLASTIC ACTIVITY; CANCER INCIDENCE; CANCER PREVENTION; CLINICAL TRIAL; CONFERENCE PAPER; DRUG EFFICACY; HUMAN; MAJOR CLINICAL STUDY; MALE; MULTICENTER STUDY; PHASE 3 CLINICAL TRIAL; PRIORITY JOURNAL; PROSTATE BIOPSY; PROSTATE CANCER;

EID: 0345868342     PISSN: 00225347     EISSN: None     Source Type: Journal    
DOI: 10.1097/01.ju.0000108260.33590.c8     Document Type: Conference Paper

References (12)

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2. The Alpha-Tocopherol, Beta Carotene Cancer Prevention Study Group: The effect of vitamin E and beta carotene on the incidence of lung cancer and other cancers in male smokers. N Engl J Med, 330: 1029, 1994
3. Lieberman, R.: Prostate cancer chemoprevention: strategies for designing efficient clinical trials. Urology, suppl 4A, 57: 224, 2001
4. Sabichi, A. L., Lee, J. J., Taylor, R. J., Thompson, I. M., Jr., Miles, B. J., Basler, J. W. et al: Selenium accumulates in prostate tissue of prostate cancer patients after short-term administration of 1-selenomethionine. Proc Am Assoc Cancer Res, 43: 1007, abstract 4993, 2002
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7. Goodman, P. J., Tangen, C. M., Crowley, J. J., Carlin, S., Ryan, A., Thompson, I. M. et al: Implementation of the Prostate Cancer Prevention Trial (PCPT). Unpublished data
8. Feigl, P., Blumenstein, B., Thompson, I., Crowley, J., Wolf, M., Kramer, B. S. et al: Design of the Prostate Cancer Prevention Trial (PCPT). Control Clin Trials, 16: 150, 1995
9. Klein, E. A., Thompson, I. M., Lippman, S. M., Goodman, P. J., Albanes, D., Taylor, P. R. et al: SELECT: the next prostate cancer prevention trial. J Urol, 166: 1311, 2001
10. Pauler, D. K., Gower, K. B., Goodman, P. J., Crowley, J. J. and Thompson, I. M.: Biomarker-based methods for determining noncompliance in a prevention trial. Control Clin Trials, 23: 675, 2002
11. Sloan, J. A. and Varricchio, C.: Quality of life endpoints in prostate chemoprevention trials. Urology, suppl., 57: 235, 2001
12. Chay, T., Goodman, P. and Hartline, J. A.: Challenges of implementing ancillary studies within multi-site clinical trials. Unpublished data