Prostate cancer prevention trial (PCPT) update

Jr Coltman C.A., Jr Thompson L.M., P. Feigl

Research output: Contribution to journalArticle

38 Citations (Scopus)

Abstract

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.

Original languageEnglish (US)
Pages (from-to)544-547
Number of pages4
JournalEuropean Urology
Volume35
Issue number5-6
DOIs
StatePublished - 1999
Externally publishedYes

Fingerprint

Prostate-Specific Antigen
Prostatic Neoplasms
Finasteride
Digital Rectal Examination
Biopsy
Transurethral Resection of Prostate
Tablets
Hyperplasia
Survivors
Prostate
Leukemia
Placebos
Sensitivity and Specificity
Serum
Neoplasms

Keywords

  • Finasteride
  • Intergroup clinical trial
  • Prevention
  • Prostate cancer

ASJC Scopus subject areas

  • Urology

Cite this

Coltman C.A., J., Thompson L.M., J., & Feigl, P. (1999). Prostate cancer prevention trial (PCPT) update. European Urology, 35(5-6), 544-547. https://doi.org/10.1159/000019895

Prostate cancer prevention trial (PCPT) update. / Coltman C.A., Jr; Thompson L.M., Jr; Feigl, P.

In: European Urology, Vol. 35, No. 5-6, 1999, p. 544-547.

Research output: Contribution to journalArticle

Coltman C.A., J, Thompson L.M., J & Feigl, P 1999, 'Prostate cancer prevention trial (PCPT) update', European Urology, vol. 35, no. 5-6, pp. 544-547. https://doi.org/10.1159/000019895
Coltman C.A. J, Thompson L.M. J, Feigl P. Prostate cancer prevention trial (PCPT) update. European Urology. 1999;35(5-6):544-547. https://doi.org/10.1159/000019895
Coltman C.A., Jr ; Thompson L.M., Jr ; Feigl, P. / Prostate cancer prevention trial (PCPT) update. In: European Urology. 1999 ; Vol. 35, No. 5-6. pp. 544-547.
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