UMIN-CTR Clinical Trial

Basic information
Public title	study of PROstate cancer, gut MicrobIome, and lifeStylE in JAPAN (PROMISE-JAPAN)
Acronym	study of PROstate cancer, gut MicrobIome, and lifeStylE in JAPAN (PROMISE-JAPAN)
Scientific Title	study of PROstate cancer, gut MicrobIome, and lifeStylE in JAPAN (PROMISE-JAPAN)
Scientific Title:Acronym	study of PROstate cancer, gut MicrobIome, and lifeStylE in JAPAN (PROMISE-JAPAN)
Region	Japan

Condition
Condition	Prostate cancer
Classification by specialty	Urology
Classification by malignancy	Malignancy
Genomic information	YES

Objectives
Narrative objectives1	Assess the association of microbiome, prostate cancer and genetic background
Basic objectives2	Others
Basic objectives -Others	Assess the association with lifestyle
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Identify Microbiome associated with prostate cancer
Key secondary outcomes

Base
Study type	Others,meta-analysis etc

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	20 years-old <=
Age-upper limit	Not applicable
Gender	Male
Key inclusion criteria	Patients with prostate cancer or suspicious prostate cancer who is above 20 years old
Key exclusion criteria	receiving Antibiotics
Target sample size	600

Research contact person
Name of lead principal investigator	1st name Uemura Middle name Last name Hirotsugu
Organization	Kindai University Faculty of Medicine
Division name	Department of Urology
Zip code	589-8511
Address	377-2 Oono-higashi, Osakasayama,
TEL	072-366-0221
Email	huemura@med.kindai.ac.jp

Public contact
Name of contact person	1st name Fujita Middle name Last name Kazutoshi
Organization	Kindai University Faculty of Medicine
Division name	Department of Urology
Zip code	589-8511
Address	377-2 Oono-higashi, Osakasayama,
TEL	072-366-0221
Homepage URL
Email	kfujita@med.kindai.ac.jp

Sponsor
Institute	Kindai University Faculty of Medicine
Institute
Department

Funding Source
Organization	Self funding
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Kindai Hospital IRB
Address	377-2 Oono-higashi, Osakasayama
Tel	072-366-0221
Email	zizen@med.kindai.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	2021 Year 04 Month 01 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
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

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2020 Year 08 Month 24 Day
Date of IRB	2020 Year 08 Month 24 Day
Anticipated trial start date	2020 Year 08 Month 24 Day
Last follow-up date	2025 Year 08 Month 24 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	None

Management information
Registered date	2021 Year 03 Month 02 Day
Last modified on	2021 Year 03 Month 05 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049660