UMIN-CTR Clinical Trial

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

prostate cancer

Classification by specialty

Urology

Classification by malignancy

Malignancy

Genomic information

NO

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

Primary outcomes

Changes in tumor marker (PSA, ratio of free to total PSA) and developing clinically manifested prostate cancer

Key secondary outcomes

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

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

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

Email

kzito@gunma-u.ac.jp

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

Email

rsuzuki@gunma-u.ac.jp

Institute

The Japanese Foundation for Prostate Research

Institute

Department

Personal name

Organization

The Japanese Foundation for Prostate Research

Organization

Division

Category of Funding Organization

Non profit foundation

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Clinical Investigation and Research Unit

Address

3-39-15, Showa-machi, Maebashi, Gunma, Japan

Tel

027-220-8740

Email

gunmaciru-office@umin.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

2015

Year

06

Month

10

Day

URL releasing protocol

none

Publication of results

Unpublished

URL related to results and publications

none

Number of participants that the trial has enrolled

887

Results

The preliminary results showing that people who frequently consumed soybeans from a young age to around 40 years old have a significantly lower risk of cancer initiation. Regarding progression to clinical manifested prostate cancer, although there were only 5 cases due to the short follow-up period, those with high soy intake at young age and during health checkups, or those with high blood Equol concentrations around age 50, may be able to suppress progression to clinical cancer.

Results date posted

2026

Year

06

Month

12

Day

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

1) Study 1: Cohort study to examine the impact of cancer initiation
Approximately 500 PSA screening participants aged 35~44 who consented to participate in this study.

For outcomes of cancer initiation, alternative indicators are used: events where the baseline PSA value in the 40s rises to 2.0 ng/ml or 3.0 ng/ml or higher, which is a high-risk factor for future prostate cancer development (5-8 years later), and when %f-PSA drops to 15% or 10% or below

2) Study 2: Cohort study to verify the impact of developing clinically manifested prostate cancer (cancer promotion)
Among PSA screening participants aged 45-54 undergoing a comprehensive medical checkup, approximately 100 men with PSA values of 2.0 ng/ml or higher, which is considered at a high risk of developing clinically manifested prostate cancer in the future, who consented to participate in this study, and about 200 men with PSA values below 2.0 ng/ml, which is considered to have a low risk of future clinically manifested prostate cancer development, who consented to participate in this study.

Participant flow

1) Study 1: Cohort study to examine the impact of microcarcinoma initiation
Approximately 500 PSA screening participants aged 35~44 who consented to participate in this study

2) Study 2: Cohort study to verify the impact of developing clinically manifested prostate cancer (promotion)
Among PSA screening participants aged 45-54 undergoing a comprehensive medical checkup, total of 300 men who consented to participate in this study were recruited, including approximately 100 men with PSA values of 2.0 ng/ml or higher, who were considered at high risk of developing clinically manifested prostate cancer in the future, and about 200 men with PSA values below 2.0 ng/ml, who were considered to have a low risk of future clinical prostate development.

Adverse events

Nothing particular

Outcome measures

primary endpoint
Investigating impacts of isoflavone concentrations, dietary/ environmental factors based on the interview (past habitual intake of soy isoflavones, past habitual intake of lycopene, exercise habits, etc.) and baseline PSA on the PSA values/ %f-PSA at the final health checkup, which is a substitute factor for cancer onset (Study 1), and developing clinically manifested prostate cancer (Study 2)

secondary endpoint
1) Verification of impacts of dynamics of serum isoflavone concentrations and PSA dynamics during the study period on the PSA values/ %f-PSA at the final health checkup (Study 1), and the risk of developing clinically manifested prostate cancer (Study 2)

2) Examination of the relationship between baseline PSA/ isoflavone concentrations and biological characteristics/ tumor activity of prostate cancer (clinical stage, histopathological differentiation, Gleason score) for prostate cancer cases identified in Study 2


3) For both the primary and secondary endpoints, similar verifications were investigated using different influencing factors such as baseline %f-PSA and %f-PSA dynamics

Plan to share IPD

IPD sharing Plan description

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 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.

Registered date

2015

Year

06

Month

03

Day

Last modified on

2026

Year

06

Month

12

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020605

Single case data URL

Value
https://center6.umin.ac.jp/ice/20605