Efficacy and safety of short-term genistein intervention in patients with localized prostate cancer prior to radical prostatectomy: a randomized, placebo-controlled, double-blind Phase 2 clinical trial.
Nutr Cancer
; 63(6): 889-98, 2011.
Article
em En
| MEDLINE
| ID: mdl-21714686
ABSTRACT
We conducted a placebo-controlled, block-randomized double-blind Phase 2 study to examine the effect of 30 mg synthetic genistein daily on serum and tissue biomarkers in patients with localized prostate cancer (CaP). Fifty-four study subjects were recruited and randomized to treatment with genistein (n = 23) or placebo (n = 24) for 3 to 6 wk prior to prostatectomy. Seven study subjects were noncompliant to the study protocol. Adverse events were few and mild. Serum prostate specific antigen (PSA) decreased by 7.8% in the genistein arm and increased by 4.4% in the placebo arm (P = 0.051). The PSA level was reduced in tumor tissue compared to normal tissue in the placebo arm. In the genistein arm, the PSA level in tumor and normal tissue was comparable. Total cholesterol was significantly lower in the genistein arm (P = 0.013). There were no significant effects on thyroid or sex hormones. Plasma concentrations of total genistein were on average 100-fold higher in the genistein arm after treatment (P < 0.001). Genistein at a dose that can be easily obtained from a diet rich in soy reduced the level of serum PSA in patients with localized CaP, without any effects on hormones. It was well tolerated and had a beneficial effect on blood cholesterol.
Texto completo:
1
Base de dados:
MEDLINE
Assunto principal:
Prostatectomia
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Neoplasias da Próstata
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Extratos Vegetais
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Genisteína
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Fitoterapia
Tipo de estudo:
Clinical_trials
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Guideline
Limite:
Humans
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Male
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Middle aged
Idioma:
En
Revista:
Nutr Cancer
Ano de publicação:
2011
Tipo de documento:
Article
País de afiliação:
Noruega