UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017789 |
|---|---|
| Receipt number | R000020605 |
| Scientific Title | Impact of primary prevention and chemoprevention on the promotion of prostate cancer and the risk of developing clinically manifested prostate cancer: A prospective cohort study |
| Date of disclosure of the study information | 2015/06/10 |
| Last modified on | 2019/06/06 17:55:42 |
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Basic information
Public title
Impact of primary prevention and chemoprevention on the promotion of prostate cancer and the risk of developing clinically manifested prostate cancer: A prospective cohort study
Acronym
A Cohort study investigating the impact of primary prevention on the development of prostate cancer
Scientific Title
Impact of primary prevention and chemoprevention on the promotion of prostate cancer and the risk of developing clinically manifested prostate cancer: A prospective cohort study
Scientific Title:Acronym
A Cohort study investigating the impact of primary prevention on the development of prostate cancer
Region
| Japan |
Condition
Condition
prostate cancer
Classification by specialty
| Urology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Investigatng the impact of diet and environment factors on the development of prostate cancer
Basic objectives2
Others
Basic objectives -Others
preventive medicine
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes in tumor marker (PSA, ratio of free to total PSA) and developing clinically manifested prostate cancer
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
| 35 | years-old | <= |
Age-upper limit
| 54 | years-old | >= |
Gender
Male
Key inclusion criteria
Men aged between 35 and 54 who participate in PSA screening within a thorough medical checkup and agree to participate after informed consent.
Key exclusion criteria
1) having past or present history of prostate cancer
2) having severe complications (caridiac disease, interstitial pneumonia, bleeding tendency, uncontrollable hypertension, diabetes mellitus, etc.)
3) having uncontrolled other malignant disease (excluding carcinoma in situ, skin cancer and no evidence of recurrence more than 3 years after the treatment)
4) having any inappropriate factor judged by investigators
Target sample size
800
Research contact person
Name of lead principal investigator
| 1st name | Kazuto |
| Middle name | |
| Last name | Ito |
Organization
Kurosawa Hospital
Division name
Institute for Preventive Medicine
Zip code
3701203
Address
187, Yanaka-cho, Takasaki, Gunma, Japan
TEL
027-352-1166
kzito@gunma-u.ac.jp
Public contact
Name of contact person
| 1st name | Rie |
| Middle name | |
| Last name | Suzuki |
Organization
Gunma University
Division name
Urology
Zip code
3718511
Address
3-39-22, Showa-machi, Maebashi, Gunma, Japan
TEL
027-220-8303
Homepage URL
rsuzuki@gunma-u.ac.jp
Sponsor or person
Institute
The Japanese Foundation for Prostate Research
Institute
Department
Personal name
Funding Source
Organization
The Japanese Foundation for Prostate Research
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Clinical Investigation and Research Unit
Address
3-39-15, Showa-machi, Maebashi, Gunma, Japan
Tel
027-220-8740
gunmaciru-office@umin.ac.jp
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
| 2015 | Year | 06 | 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
887
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
No longer recruiting
Date of protocol fixation
| 2015 | Year | 02 | Month | 24 | Day |
Date of IRB
| 2015 | Year | 02 | Month | 24 | Day |
Anticipated trial start date
| 2015 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This prospective cohort study investigate impact of diet and environment factors on the promoting and developing prostate cancer and include two cohorts as indicated below.
The cohort 1 investigates impacts of serum isoflavone concentration and life-style (diet including soybean, isoflavone and lycopene, etc.) on the initiation and promotion of prostate cancer. Participants are men aged between 35 and 44 who participate in prostate-specific antigen (PSA)-based screening in Kurosawa Hospital. Participants will be checked baseline serum isoflavone and life-style in 20-25 years old and at the enrollment using a validated questionnaire and will be followed for 5 to 8 years. The surrogate primary endpoints are risk of increased PSA above 2.0ng/ml or 3.0ng/ml and changes in the ratio of free to total PSA (%f-PSA) below 15% or 10%. The impact of baseline isoflavone concentration and life-style in 20-25 years old and at the enrollment on the surrogate endpoints will be investigated.
The cohort 2 investigates impacts of serum isoflavone concentration and life-style on the development of clinically manifested prostate cancer. Participants are men aged between 45 and 54 including high risk men whose baseline PSA above 2.0ng/ml and low risk men with PSA below 2.0ng/ml. The baseline assessment is the same as the cohort 1. The impact of baseline isoflavone concentration and life-style in 20-25 years old and at the enrollment on the development clinically manifested prostate cancer will be investigated.
Management information
Registered date
| 2015 | Year | 06 | Month | 03 | Day |
Last modified on
| 2019 | Year | 06 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020605
| Research Plan | |
|---|---|
| Registered date | File name |
| 2019/06/06 | イソフラボン同意書150422.docx |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| 2019/06/06 | 記録用紙150123.pdf |
| Research case data | |
|---|---|
| Registered date | File name |
| 2019/06/06 | 記録用紙150123.pdf |
Single case data URL
Value
https://center6.umin.ac.jp/ice/20605
