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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000029069
Receipt No. R000033246
Scientific Title Baseline PSA distribution and estimated prevalence of prostate cancer in men participated in PSA screening for the first time: Longitudinal changes for 25 years in Gunma and international comparison between Gunma and ERSPC, Rotterdam in 1990's
Date of disclosure of the study information 2017/09/11
Last modified on 2019/03/11

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Basic information
Public title Baseline PSA distribution and estimated prevalence of prostate cancer in men participated in PSA screening for the first time: Longitudinal changes for 25 years in Gunma and international comparison between Gunma and ERSPC, Rotterdam in 1990's
Acronym International comparison of PSA distribution and estimated prevalence of prostate cancer in men participated in PSA screening.
Scientific Title Baseline PSA distribution and estimated prevalence of prostate cancer in men participated in PSA screening for the first time: Longitudinal changes for 25 years in Gunma and international comparison between Gunma and ERSPC, Rotterdam in 1990's
Scientific Title:Acronym International comparison of PSA distribution and estimated prevalence of prostate cancer in men participated in PSA screening.
Region
Japan Europe

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

Objectives
Narrative objectives1 Previous studies demonstrated that baseline PSA could strongly correlated with the future risk of developing prostate cancer and the probability of prostate cancer at present. Therefore, we hypothesized that baseline PSA distribution in men screened for prostate cancer for the first time might be strongly correlated with the true incidence of prostate cancer.
In the present study, we investigate changes in the PSA distribution with age and estimated probability of prostate cancer calculated by Prostate cancer Risk Calculator 2, which is looking at the levels of PSA in patient's blood and subsequently estimates the risk of having prostate cancer. Incidence adjusted by the age structure of the WHO 2000 World Standard Population (AIR) of prostate cancer will be calculated using prevalence of prostate cancer estimated by Prostate cancer Risk Calculator 2 for Gunma and Rotterdam sections. Furthermore, we will investigate difference in the AIR of prostate cancer between data estimated by Prostate cancer Risk Calculator 2 and data published in epidemiological surveys in Gunma and Rotterdam section. Changes in estimated AIR of prostate cancer during 25 years in Gunma section and difference in the estimated AIR between Gunma and Rotterdam will be investigated.
Clinicopathological features of prostate cancer detected at the initial screening visit will be surveyed in Gunma and Rotterdam sections. Then, changes in the clinicopathological features of prostate cancer during 25 years will be investigated in Gunma section. International comparison in the clinicopathological features of prostate cancer detected at initial screening will be carried out using Gunma and Rotterdam data.
Basic objectives2 Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes 1) Investigating changes in the baseline PSA distributions with age and estimated AIR during 25 years in Gunma section.
2) International comparison in the baseline PSA distributions with age and estimated AIR between Gunma and Rotterdam.
Key secondary outcomes 1) Investigating 25-year changes in the clinicopathological features of prostate cancer detected at the initial screening in Gunma section.
2) International comparison in the clinicopathological features of prostate cancer detected at initial screening in Gunma and Rotterdam sections.

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
50 years-old <=
Age-upper limit
79 years-old >=
Gender Male
Key inclusion criteria Participants in the Gunma section will be about 75,000 men aged 50 to 79 who underwent PSA screening for the first time in the population-based screening in Gunma Prefecture, Japan, between January 1992 and December 2016.
Participants in the Rotterdam section will be about 20,000 men aged 50 to 79 who participated in the first round of PSA screening in the ERSPC, Rotterdam, between November 1993 and December 1999.
Key exclusion criteria Men who have rejected to participate in the study.
Target sample size 100000

Research contact person
Name of lead principal investigator
1st name Kazuto
Middle name
Last name Ito
Organization Gunma University Graduate School of Medicine
Division name Department of Urology
Zip code 3718511
Address 3-39-22, Showa-machi, Maebashi-city, Gunma 371-8511, Japan
TEL 027-220-8301
Email kzito@gunma-u.ac.jp

Public contact
Name of contact person
1st name Kazumi
Middle name
Last name Masui
Organization Gunma University Hospital
Division name Clinical Investigation and Research Unit
Zip code 3718511
Address 3-39-15, Showa-machi, Maebashi-city, Gunma 371-8511, Japan
TEL 027-220-8740
Homepage URL
Email hitotaisho-ciru@ml.gunma-u.ac.jp

Sponsor
Institute Gunma University Graduate School of Medicine
Institute
Department

Funding Source
Organization Department of Urology, Gunma University Graduate School of Medicine
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor Department of Urology, Erasmus University Medical Center, Rotterdam, Netherlands
Name of secondary funder(s) None

IRB Contact (For public release)
Organization Clinical Investigation and Research Unit, Gunma University Hospital
Address 3-39-15, Showa-machi, Maebashi-city, Gunma 371-8511, Japan
Tel 027-220-8740
Email hitotaisho-ciru@ml.gunma-u.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
2017 Year 09 Month 11 Day

Related information
URL releasing protocol
Publication of results Partially published

Result
URL related to results and publications
Number of participants that the trial has enrolled 92621
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
2017 Year 09 Month 05 Day
Date of IRB
2017 Year 09 Month 05 Day
Anticipated trial start date
2017 Year 09 Month 15 Day
Last follow-up date
2019 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information According to the epidemiological surveys, the mortality rate of prostate cancer had increased from 1970 to 2013 and had rapidly increased in the past several years.
However, the reliability of epidemiological data on the mortality and incidence of prostate cancer could be low in Japan because of the lack of reliable death certificate system and cancer registry system, especially in the past. Therefore, it may be difficult to know true trends in the incidence and mortality of prostate cancer.
A fundamental reasons of rapid increase in the incidence of prostate cancer in Japan demonstrated by epidemiological survey might not be due to true increase in the risk of developing prostate cancer. The penetration of PSA screening strongly affects the number of newly diagnosed prostate cancer in the country. Therefore, we need a reliable and an objective index in order to know true changes in the risk of developing prostate cancer in each country.
Previous studies demonstrated that baseline PSA could strongly correlated with the future risk of developing prostate cancer and the probability of prostate cancer at present.

Management information
Registered date
2017 Year 09 Month 08 Day
Last modified on
2019 Year 03 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033246

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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