The isoflavone intake and ecole production ability as a prostate cancer risk ; double blind placebo study

UMIN ID: C000000446

Registered date:10/07/2006

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Prostate cancer
• Date of first enrollment: 2005/12/01
• Target sample size: 280
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Soybean isoflavone 60mg (10 tablets) a day per oral
Placebo (10 tablets) a day per oral

Outcome(s)

• Primary Outcome: Compliance of soybean isoflavone 60mg a day per oral Comparison of serum testosterone, serum DHT, serum SHBG, serum estradiol and serum PSA before and after isoflavone intake.

Key inclusion & exclusion criteria

• Age minimum: 50years-old
• Age maximum: 75years-old
• Gender: Male
• Exclude criteria: 1. History of a prostate cancer 2. High grade PIN in the prostate needle biopsy 3. Past history of surgery of the prostate(transurethral resection, balloon dilation, hyperthermia, stenting et al.) 4. Past history of malignant disease within 5 years other than basal cell carcinoma or squamous cell carcinoma of the skin. 5. The myocardial infarction, coronary artery bypass,unstable angina, arrhythmia, congestive heart failure, cerebral ischemia, uncontrolled diabetes or controlled peptic ulcer. 6. Abnormalities of liver function; more than double level of AST, ALT or ALP, time and a half level of bilirubin. 7. Abnormalities of renal function; more than time and a half level of creatinin. 8. Combined use or use within 12 months of the following drugs; 5 alpha-reductase inhibitor, steroid hormone, anti-androgens (fultamide, bicalutamide, chlormadinone acetate, estrogen, progesterone).anti-androgen action.

Related Information

• Primary Sponsor: Graduate School of Comprehensive Human Sciences, University of Tsukuba
• Source(s) of Monetary Support: Grants-in-Aid for Scientific Research