Prostate Cancer Chemoprevention Study

An investigative randomized control study using purified isoflavones in men with rising prostate-specific antigen

Naoto Miyanaga, Hideyuki Akaza, Shiro Hinotsu, Tomoaki Fujioka, Seiji Naito, Mikio Namiki, Satoru Takahashi, Yoshihiko Hirao, Shigeo Horie, Taiji Tsukamoto, Mitsuru Mori, Hirokazu Tsuji

Research output: Contribution to journalArticle

40 Citations (Scopus)

Abstract

Our previous case-control study suggested that equol, a metabolite of isoflavone, has a preventive effect on prostate cancer. To examine the prostate cancer risk based on isoflavone intake and equol production, we carried out a phase II, randomized, double-blind, placebo-controlled trial of oral isoflavone (60mg/day) for 12months. The inclusion criteria were Japanese men between 50 and 75years of age, a serum prostate-specific antigen level of 2.5-10.0ng/mL, and a single, negative prostate biopsy within 12months prior to enrollment. The study included 158 men in eight Japanese centers. Their median age was 66.0years, and the numbers of equol producers and non-producers were 76 (48%) and 82 (52%), respectively. The majority of adverse events were mild or moderate in severity, and the scheduled intake of tablets was completed by 153 patients (96.8%). The prostate-specific antigen value showed no significant difference before and after treatment. Of the 89 patients evaluated by central pathological review, the incidence of biopsy-detectable prostate cancer in the isoflavone and placebo groups showed no significant difference (21.4%vs 34.0%, P=0.140). However, for the 53 patients aged 65years or more, the incidence of cancer in the isoflavone group was significantly lower than that in the placebo group (28.0%vs 57.1%, P=0.031). These results support the value of isoflavone for prostate cancer risk reduction. A large-scale phase III randomized study of isoflavone tablets in men with different hereditary factors and living environments is warranted. Registered with the UMIN Clinical Trials Registry (UMIN-CTR) for clinical trials in Japan (C000000446).

Original languageEnglish
Pages (from-to)125-130
Number of pages6
JournalCancer Science
Volume103
Issue number1
DOIs
Publication statusPublished - Jan 2012
Externally publishedYes

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Isoflavones
Chemoprevention
Prostate-Specific Antigen
Prostatic Neoplasms
Equol
Placebos
Tablets
Clinical Trials
Biopsy
Incidence
Risk Reduction Behavior
Registries
Case-Control Studies
Prostate
Japan
Serum

ASJC Scopus subject areas

  • Cancer Research
  • Oncology

Cite this

Prostate Cancer Chemoprevention Study : An investigative randomized control study using purified isoflavones in men with rising prostate-specific antigen. / Miyanaga, Naoto; Akaza, Hideyuki; Hinotsu, Shiro; Fujioka, Tomoaki; Naito, Seiji; Namiki, Mikio; Takahashi, Satoru; Hirao, Yoshihiko; Horie, Shigeo; Tsukamoto, Taiji; Mori, Mitsuru; Tsuji, Hirokazu.

In: Cancer Science, Vol. 103, No. 1, 01.2012, p. 125-130.

Research output: Contribution to journalArticle

Miyanaga, N, Akaza, H, Hinotsu, S, Fujioka, T, Naito, S, Namiki, M, Takahashi, S, Hirao, Y, Horie, S, Tsukamoto, T, Mori, M & Tsuji, H 2012, 'Prostate Cancer Chemoprevention Study: An investigative randomized control study using purified isoflavones in men with rising prostate-specific antigen', Cancer Science, vol. 103, no. 1, pp. 125-130. https://doi.org/10.1111/j.1349-7006.2011.02120.x
Miyanaga, Naoto ; Akaza, Hideyuki ; Hinotsu, Shiro ; Fujioka, Tomoaki ; Naito, Seiji ; Namiki, Mikio ; Takahashi, Satoru ; Hirao, Yoshihiko ; Horie, Shigeo ; Tsukamoto, Taiji ; Mori, Mitsuru ; Tsuji, Hirokazu. / Prostate Cancer Chemoprevention Study : An investigative randomized control study using purified isoflavones in men with rising prostate-specific antigen. In: Cancer Science. 2012 ; Vol. 103, No. 1. pp. 125-130.
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