Clinical Trial Designs for Chemoprevention of Prostate Cancer
Prostate Cancer Prevention Trial (PCPT) UpdateThompson, Jr. I.M.b · Feigl P.c
aSouthwest Oncology Group; bBrooke Army Medical Center, San Antonio, Tex., and cFred Hutchinson Cancer Research Center, Seattle, Wash., USA
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The Prostate Cancer Prevention Trial is an intergroup effort in the USA managed by the Southwest Oncology Group (SWOG) in collaboration with the Eastern Cooperative Oncology Group (ECOG) and the Cancer and Leukemia Group B (CALGB). This 10-year study began approximately 5 years ago and will achieve its primary endpoint in October 2004. At the start of the study, 18,882 men, aged over 55 years, and with normal digital rectal examination (DRE) and serum prostate-specific antigen (PSA) levels of ≤3.0 ng/ml were randomized to take finasteride (5 mg/day) or placebo (1 tablet/day). DRE and PSA have been determined yearly (PSA in a central laboratory). When DRE is abnormal or PSA rises to >4.0 ng/ml, a biopsy is recommended. Because of the effect finasteride has on PSA, the PSA value has been indexed to equalize the number of biopsies in both arms. At 7 years all survivors will undergo a sextant biopsy to determine the period prevalence of prostate cancer. The critical assumptions are: (1) finasteride-induced PSA changes result in a simple downward shift; (2) the assessment of adherence is sensitive enough to detect nonadherence affecting PSA level interpretation: (3) factors affecting biopsy loss will be equal in both arms; (4) finasteride does not affect the sensitivity or specificity of DRE on transrectal ultrasound nor the sensitivity of biopsy; (5) bias resulting from transurethral resection of the prostate in benign prostate hyperplasia cases will be negligible.
- Landis SH, Murray T, Bolden S, Wingo PA: Cancer Statistics, 1998. CA Cancer J Clin 1998;48:6–30.
- Von Eschenbach A, Ho R, Murphy GF, Cunningham M, Lins N: American Cancer Society guidelines for the early detection of prostate cancer. Cancer 1997;80:1805–1807.
Huggins C, Hodges CV: Studies on prostate cancer. I. The effect of castration, of estrogen, and of androgen injection on serum phosphatases in metastatic carcinoma of the prostate. Cancer Res 1941;1:293.
- Ross RK, Bernstein L, Lobo RA et al: Evidence for reduced 5-alpha-reductase activity in Japanese compared to US white and black males: Implications for prostate cancer risk. Lancet 1992;339:887–889.
- Peters CA, Walsh PC: The effect of nafarelin acetate, a luteinizing hormone-releasing hormone agonist, on benign prostatic hyperplasia. N Engl J Med 1987;317:599–604.
- Imperato-McGinley J, Guerreo L, Gautier T et al: Steroid 5-alpha-reductase deficiency in man: An inherited form of male pseudohermaphroditism. Science 1974;186:1213–1215.
- Walsh PC, Madden JD, Harrod MJ et al: Familial incomplete male pseudohermaphroditism, type 2: Decreased dihydrotestosterone formation in pseudovaginal perineoscrotal hypospadias. N Engl J Med 1974;291:944–949.
- Metcalf BW, Levy MA, Holt DA: Inhibitors of steroid 5-alpha-reductase in benign prostatic hyperplasia, male pattern baldness and acne. Trends Pharmacol Sci 1989;10:491–495.
- Gormley GJ, Stoner E, Bruskewitz RC et al: The effect of finasteride in men with benign prostatic hyperplasia. N Engl J Med 1992;327:1185–1191.
Bologna M, Muzi P, Biordi L et al: Antiandrogens and 5-alpha-reductase inhibition of the proliferation rate in PC3 and DU145 human prostatic cancer cell lines. Curr Ther Res 1992;51:799–813.
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