Flutamide in men with prostatic intraepithelial neoplasia: A randomized, placebo-controlled chemoprevention trial

Steven Robert Alberts, Paul J. Novotny, Jeff A Sloan, John Danella, David G. Bostwick, Thomas J. Sebo, Michael L. Blute, Tom R. Fitch, Ralph Levitt, Ronald Lieberman, Charles Lawrence Loprinzi

Research output: Contribution to journalArticle

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Abstract

High-grade prostatic intraepithelial neoplasia (HGPIN) has been identified as a premalignant change in the prostate that indicates increased risk of the subsequent development of prostate adenocarcinoma. Prior studies have suggested that androgen deprivation therapy causes a regression of HGPIN. We therefore conducted a chemoprevention trial assessing the efficacy of flutamide in reducing the rate of prostate adenocarcinoma development in men with HGPIN. Men with biopsyproven HGPIN but no evidence of prostate adenocarcinoma were randomized in a double-blind manner to either flutamide 250 mg/d or a placebo. Treatment was continued for 1 year. Repeat biopsies were obtained at 12 and 24 months. Quality of life and toxicities related to treatment were also measured. Sixty patients were randomized and began therapy with either flutamide or placebo. At 1 year, 14% of men receiving flutamide and 10% of men receiving placebo had developed prostate adenocarcinoma. Flutamide-associated toxicities were mild to moderate in severity. Quality-of-life measures did not show any differences between the 2 groups. This study showed no evidence of benefit from flutamide as a chemoprevention agent in men with HGPIN.

Original languageEnglish (US)
Pages (from-to)291-297
Number of pages7
JournalAmerican Journal of Therapeutics
Volume13
Issue number4
DOIs
StatePublished - Jul 2006

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Prostatic Intraepithelial Neoplasia
Flutamide
Chemoprevention
Placebos
Prostate
Adenocarcinoma
Quality of Life
Therapeutics
Androgens
Biopsy

Keywords

  • Chemoprevention
  • Flutamide
  • Prostate cancer
  • Prostatic intraepithelial neoplasia

ASJC Scopus subject areas

  • Pharmacology

Cite this

Flutamide in men with prostatic intraepithelial neoplasia : A randomized, placebo-controlled chemoprevention trial. / Alberts, Steven Robert; Novotny, Paul J.; Sloan, Jeff A; Danella, John; Bostwick, David G.; Sebo, Thomas J.; Blute, Michael L.; Fitch, Tom R.; Levitt, Ralph; Lieberman, Ronald; Loprinzi, Charles Lawrence.

In: American Journal of Therapeutics, Vol. 13, No. 4, 07.2006, p. 291-297.

Research output: Contribution to journalArticle

Alberts, Steven Robert ; Novotny, Paul J. ; Sloan, Jeff A ; Danella, John ; Bostwick, David G. ; Sebo, Thomas J. ; Blute, Michael L. ; Fitch, Tom R. ; Levitt, Ralph ; Lieberman, Ronald ; Loprinzi, Charles Lawrence. / Flutamide in men with prostatic intraepithelial neoplasia : A randomized, placebo-controlled chemoprevention trial. In: American Journal of Therapeutics. 2006 ; Vol. 13, No. 4. pp. 291-297.
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