UMIN-CTR Clinical Trial

Public title

Assessment for screening for prostate cancer in Gunma

Acronym

Assessment for screening for prostate cancer in Gunma

Scientific Title

Case-control and etiological studies on the efficacy of screening for prostate cancer

Scientific Title:Acronym

PROstate Cancer Screening study on Death due to prostate cancer (PROCEED)

Region

Japan

Condition

prostate cancer

Classification by specialty

Urology

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

Combining individual data on screening for prostate cancer and cancer registry including prognostic survey in Gunma Prefecture, and subsequently investigating relationship between screening history and risk of death due to prostate cancer.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Case control study in Isesaki city (old Isesaki city; original community before municipal merger) and in Gunma prefecture excluding Isesaki city.
Investigating relationship between PSA-based screening history and death due to prostate cancer (estimating odds ratio) in men aged below 85 years old (the age of having life expectancy of 7 years or longer) Candidates for influencing factor on screening histories are followings;
1) Population-based PSA screening history before cancer detection: none vs. present
2) Diagnostic opportunity (data from MN report): screening vs. outpatient clinic due to having any urinary symptoms
3) Population-based PSA screening history within 2 years before cancer detection: none vs. present
4) Population-based PSA screening history within 5 years before cancer detection: none vs. present
5) Population-based PSA screening history within 5 years before cancer detection: none or only once vs. present more than once

Key secondary outcomes

<1> Case control study in Isesaki city (old Isesaki city; original community before municipal merger) and in Gunma prefecture excluding Isesaki city.
Investigating relationship between PSA-based screening history and death due to prostate cancer in men dead at the age below 85 years old in Isesaki city (old Isesaki city) and in Gunma prefecture excluding Isesaki city. Candidates for influencing factor on screening histories are followings;
Population-based PSA screening history within 10 years before cancer detection:
1) none vs. present
2) none or only once vs. present more than once
3) none, once, twice vs. present more than twice
Investigating above indicated primary and secondary outcomes in men dead due to prostate cancer at the age below 80 years old or 75 years old
<2> Retrospective cohort study: Estimating cumulative risk of detecting prostate cancer in the late clinical stage and death due to prostate cancer stratified by baseline PSA (0.0-1.0/1.1-2.0/2.1-3.0/3.1-4.0/4.1-10.0/10.1-20.0/20.1-50.0/50.1 or higher) and the age (50-54/55-59/60-64/65-69/70-74/75-79 years old)
<3> Etiological study
1) Time series study: Estimating relationship of annual percent change (APC) in age standardized incidence of prostate cancer (1992-2015), age standardized incidence of metastatic prostate cancer (1992-2015) and age standardized mortality of prostate cancer (1992-2020) with exposure rate of PSA screening until 2019, stratified by municipality and the year of initiation of population-based screening
2) Regional correlation study: Grouping municipalities according to exposure rate of PSA screening between the year of initiation of PSA screening and 2019, and subsequently investigating relationship between exposure rate of PSA screening and APC in age standardized incidence of prostate cancer (1992-2015), age standardized incidence of metastatic prostate cancer (1992-2015) and age standardized mortality of prostate cancer (1992-2020)

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

Age-lower limit

20

years-old

<=

Age-upper limit

Not applicable

Gender

Male

Key inclusion criteria

1) Men aged above 20 years old and participating population-based screening for prostate cancer in Gunma Prefecture* between April 1992 and March 2020. *municipalities where Gunma Health Foundation have gotten entrusted population-based screening
2) Men aged above 20 years old and participating population-based screening for prostate cancer in old Isesaki city between April 2002 and March 2020.
3) Men diagnosed with prostate cancer and registered in Gunma Prefecture Cancer Registry between January 1992 and December 2015 from the municipalities where Gunma Health Foundation or Isesaki prostate cancer screening committee have conducted population-based screening

Key exclusion criteria

1) All inhabitants living in the municipalities decided not to participate in the present study (clarified the intention of opt-out for the present study)
2) All individuals who clarified the intention of opt-out for the present study (excluding data for the case-control study and the retrospective cohort study)
3) All individuals who died or could not clarify their own intention and whom direct relatives clarified the intention of opt-out for the present study (excluding data for the case-control study and the retrospective cohort study)
4) Men whom physicians or researchers recommended to exclude from the present study.

Target sample size

1000

Name of lead principal investigator

1st name	Yoshitaka
Middle name
Last name	Sekine

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

027-220-8306

Email

ysekine@gunma-u.ac.jp

Name of contact person

1st name	Yoshitaka
Middle name
Last name	Sekine

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

027-220-8306

Homepage URL

Email

ysekine@gunma-u.ac.jp

Institute

Department of Urology, Gunma University Graduate School of Medicine

Institute

Department

Personal name

Organization

Department of Urology, Gunma University Graduate School of Medicine

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Japan

Co-sponsor

Gunma Prefecture Cancer Registry
Gunma Health Foundation
Isesaki prostate cancer screening committee
Gunma University Center Mathematics and Data Science
Department of Public Health, Gunma University Graduate School of Medicine
Gunma Prefectural Institute of Public Health and Environmental Sciences
Institute for Preventive Medicine, Kurosawa Hospital

Name of secondary funder(s)

Institute for Preventive Medicine, Kurosawa Hospital

Organization

Gunma University Hospital Clinical Research Review Board

Address

3-39-22, Showa-machi, Maebashi-city, Gunma 371-8511, Japan

Tel

027-220-8741

Email

eguchi@jimu.gunma-u.ac.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2021

Year

02

Month

01

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Preinitiation

Date of protocol fixation

2020

Year

11

Month

06

Day

Date of IRB

Anticipated trial start date

2021

Year

03

Month

01

Day

Last follow-up date

2025

Year

03

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

The analysis will be done by using the coupled databases of screening, cancer registration and information of prognosis, which were numbered without reference to individual informations, in both "Gunma University Center Mathematics and Data Science" and "Department of Urology, Gunma University Graduate School of Medicine".
Registrations in the databases are followings:
1) Individual number
2) Screening : hometown, age at the screening, PSA, history of complete examination, history of prostate biopsy, result of screening
3) Cancer registration : entries recorded in MN report
4) Information of prognosis : survival confirmation date, date of death due to prostate cancer, date of death due to other causes

Registered date

2021

Year

01

Month

26

Day

Last modified on

2021

Year

01

Month

26

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049237