UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029069 |
|---|---|
| Receipt number | 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 | 2020/09/10 10:05:31 |
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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
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
hitotaisho-ciru@ml.gunma-u.ac.jp
Sponsor or person
Institute
Gunma University Graduate School of Medicine
Institute
Department
Personal name
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
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
https://onlinelibrary.wiley.com/doi/full/10.1002/ijc.31560
Publication of results
Partially published
Result
URL related to results and publications
https://onlinelibrary.wiley.com/doi/full/10.1002/ijc.31560
Number of participants that the trial has enrolled
92621
Results
The calculated coefficients of linear regression for age versus log10 PSA fluctuated during the 25-year period, but no trend
was observed. In addition, the percentage of men with a PSA above cut-off values varied in each 5-year period, with no specific
trend. The risk calculator (RC)-based AIR of PC and CSPC were stable between 1992 and 2016. Therefore, the baseline
risk for developing PC has remained unchanged in the past 25 years, in Japan.
Results date posted
| 2020 | Year | 09 | Month | 10 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2018 | Year | 04 | Month | 26 | Day |
Baseline Characteristics
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.
Participant flow
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.
Adverse events
none
Outcome measures
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
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
| 2020 | Year | 09 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033246
| Research Plan | |
|---|---|
| Registered date | File name |
| 2020/09/10 | kei_zinsokuC_PSA changes for 25 years_20180612.docx |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| 2020/09/10 | kei_zinsokuC_PSA changes for 25 years_20180612.docx |
| Research case data | |
|---|---|
| Registered date | File name |
| 2020/09/10 | Gunma cohort_Table S1_IJC_FINAL_0417.xlsx |
