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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN C000000446
Receipt No. R000000541
Scientific Title The isoflavone intake and ecole production ability as a prostate cancer risk ; double blind placebo study
Date of disclosure of the study information 2006/07/10
Last modified on 2011/02/27

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Basic information
Public title The isoflavone intake and ecole production ability as a prostate cancer risk ; double blind placebo study
Acronym The isoflavone intake and ecole production ability as a prostate cancer risk
Scientific Title The isoflavone intake and ecole production ability as a prostate cancer risk ; double blind placebo study
Scientific Title:Acronym The isoflavone intake and ecole production ability as a prostate cancer risk
Region
Japan

Condition
Condition Prostate cancer
Classification by specialty
Urology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the tolerability of soybean isoflavone 60mg a day per oral, endocrinological kinetics, and the change of serum PSA level.
Basic objectives2 Others
Basic objectives -Others The incidence of prostate cancer detected in the needle biopsy of one year later; between placebo group and administered group, ecole producer and non-producer.
The pathological findings of detected prostate cancer in the needle biopsy of one year later; between placebo group and administered group.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes 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 secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Placebo
Stratification YES
Dynamic allocation
Institution consideration Institution is considered as adjustment factor in dynamic allocation.
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Food
Interventions/Control_1 Soybean isoflavone 60mg (10 tablets) a day per oral
Interventions/Control_2 Placebo (10 tablets) a day per oral
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
50 years-old <=
Age-upper limit
75 years-old >=
Gender Male
Key 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.
Key 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.
Target sample size 280

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hideyuki Akaza
Organization Graduate School of Comprehensive Human Sciences
University of Tsukuba
Division name Department of Urology
Zip code
Address 1-1-1 Tennodai, Tsukuba, Ibaraki 305-8575, Japan
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name Naoto Miyanaga
Organization Graduate School of Comprehensive Human Sciences, University of Tsukuba
Division name Department of Urology
Zip code
Address 1-1-1 Tennodai, Tsukuba, Ibaraki 305-8575, Japan
TEL
Homepage URL
Email

Sponsor
Institute Graduate School of Comprehensive Human Sciences, University of Tsukuba
Institute
Department

Funding Source
Organization Grants-in-Aid for Scientific Research
Organization
Division
Category of Funding Organization
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2006 Year 07 Month 10 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2005 Year 10 Month 25 Day
Date of IRB
Anticipated trial start date
2005 Year 12 Month 01 Day
Last follow-up date
2009 Year 09 Month 01 Day
Date of closure to data entry
2009 Year 09 Month 01 Day
Date trial data considered complete
2009 Year 10 Month 01 Day
Date analysis concluded
2009 Year 11 Month 01 Day

Other
Other related information

Management information
Registered date
2006 Year 07 Month 05 Day
Last modified on
2011 Year 02 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000541

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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