Prostate cancer
Conditions
Interventions
Soybean isoflavone 60mg (10 tablets) a day per oral
Placebo (10 tablets) a day per oral
Sponsors
Graduate School of Comprehensive Human Sciences, University of Tsukuba
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: The result of the prostate needle biopsy within 12 months was negative. The number of biopsy is not considered. The total PSA level is in the following range. 50 - 60 years old: 2.5 ng/mL<=PSA<=10 ng/mL 61 - 75 years old: 3.0 ng/mL<=PSA<=10 ng/mL The pateint can take control and intake the tablets by oneself. The pateint can be enrolled and agrees to imformed consent.
Exclusion criteria
Exclusion 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Japan
Contacts
Public ContactNaoto Miyanaga
Graduate School of Comprehensive Human Sciences, University of Tsukuba Department of Urology
Outcome results
None listed