Assessment for screening for prostate cancer in Gunma

Case-control and etiological studies on the efficacy of screening for prostate cancer - PROstate Cancer Screening study on Death due to prostate cancer (PROCEED)

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000043131

Enrollment

1000

Registered

2021-02-01

Start date

2021-03-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

prostate cancer

Interventions

None listed

Eligibility

Sex/Gender

Male

Inclusion criteria

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

Exclusion criteria

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.

Design outcomes

Primary

Measure	Time frame
Case-control study in Isesaki City (old Isesaki City before municipal merger) and Gunma Prefecture excluding Isesaki City. We investigate the association between PSA-based screening history (PSH) and prostate cancer death in men aged under 85 years, the age group with life expectancy of 7 years or longer, by estimating odds ratios. Candidate PSH-related factors are: 1) Population-based PSH before cancer detection: none vs. present 2) Diagnostic opportunity (MN report): PSH vs. outpatient visit for urinary symptoms 3) Population-based PSA screening within 2 years before cancer detection: none vs. present 4) Population-based PSH within 5 years before cancer detection: none vs. present 5) Population-based PSH within 5 years before cancer detection: none or once vs. more than once 6) For item 2, subgroup analysis by PSH 3-5 years before cancer detection: with vs. without PSH 7) For items 4 and 5, subgroup analysis by PSH 6-10 years before cancer detection: with vs. without PSH Note: If a patient had screening but did not undergo further examination despite an abnormal PSA result, and cancer was later detected due to symptoms or during treatment/follow-up for another condition, the past screening is treated as non-compliance, not effective compliance. Such cases are classified as no effective screening history (NHS), even if PSH exists, and items 1-7 are also analyzed using the definitions below. Effective Compliance Analysis [1] If screening was followed by abnormal PSA without further examination, and final detection was incidental during follow-up for another condition or unknown/symptomatic, the corresponding PSH is treated as non-effective compliance history (NHC). [2] If screening was followed by abnormal PSA without further examination, and final detection was due to unknown/symptomatic causes, the corresponding PSH is treated as NHC.	—

Measure

Time frame

Case-control study in Isesaki City (old Isesaki City before municipal merger) and Gunma Prefecture excluding Isesaki City. We investigate the association between PSA-based screening history (PSH) and prostate cancer death in men aged under 85 years, the age group with life expectancy of 7 years or longer, by estimating odds ratios. Candidate PSH-related factors are: 1) Population-based PSH before cancer detection: none vs. present 2) Diagnostic opportunity (MN report): PSH vs. outpatient visit for urinary symptoms 3) Population-based PSA screening within 2 years before cancer detection: none vs. present 4) Population-based PSH within 5 years before cancer detection: none vs. present 5) Population-based PSH within 5 years before cancer detection: none or once vs. more than once 6) For item 2, subgroup analysis by PSH 3-5 years before cancer detection: with vs. without PSH 7) For items 4 and 5, subgroup analysis by PSH 6-10 years before cancer detection: with vs. without PSH Note: If a patient had screening but did not undergo further examination despite an abnormal PSA result, and cancer was later detected due to symptoms or during treatment/follow-up for another condition, the past screening is treated as non-compliance, not effective compliance. Such cases are classified as no effective screening history (NHS), even if PSH exists, and items 1-7 are also analyzed using the definitions below. Effective Compliance Analysis [1] If screening was followed by abnormal PSA without further examination, and final detection was incidental during follow-up for another condition or unknown/symptomatic, the corresponding PSH is treated as non-effective compliance history (NHC). [2] If screening was followed by abnormal PSA without further examination, and final detection was due to unknown/symptomatic causes, the corresponding PSH is treated as NHC.

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Secondary

Measure	Time frame
<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)	—

Measure

Time frame

<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)

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Countries

Japan

Contacts

Public ContactYoshitaka Sekine

Gunma University Graduate School of Medicine Department of Urology

ysekine@gunma-u.ac.jp027-220-8306

Outcome results