UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | C000000446 |
|---|---|
| Receipt number | 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 16:12:10 |
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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
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
Sponsor or person
Institute
Graduate School of Comprehensive Human Sciences, University of Tsukuba
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000541
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