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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000027832
Receipt No. R000031880
Scientific Title Is 5-alpha reductase inhibitor capable to alter the natural history of slightly enlarged prostate? a prospective multi center study
Date of disclosure of the study information 2017/06/20
Last modified on 2019/06/26

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Basic information
Public title Is 5-alpha reductase inhibitor capable to alter the natural history of slightly enlarged prostate? a prospective multi center study
Acronym Five-alpha reductase inhibitor for slightly enlarged prostate with LUTS
Scientific Title Is 5-alpha reductase inhibitor capable to alter the natural history of slightly enlarged prostate? a prospective multi center study
Scientific Title:Acronym Five-alpha reductase inhibitor for slightly enlarged prostate with LUTS
Region
Japan

Condition
Condition Benign Prostatic Hyperplasia
Classification by specialty
Urology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To assess the effect of 5-alpha reductase inhibitor in BPH patients having prostate volume less than 30 ml and classified as Group 3 by transrectal ultrasound.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Phase I,II

Assessment
Primary outcomes change of prostate volume and adherence to prescribed drugs
Key secondary outcomes change of LUTS

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

Not applicable
Gender Male
Key inclusion criteria patients newly diagnosed as BPH with IPSS eight points or greater, prostate volume less than 30 ml and Group 3 by transrectal ultrasound
Key exclusion criteria use of drugs affecting prostate volume such as antiandrogenic agent
Target sample size 27

Research contact person
Name of lead principal investigator
1st name Fumimasa
Middle name
Last name Fukuta
Organization Sapporo medical university school of medicine
Division name the department of urology
Zip code 060-8543
Address Minami 1 Jo Nishi 16 Chome, Chuo-ku, Sapporo-shi
TEL 011-611-2111
Email ffukuta@sapmed.ac.jp

Public contact
Name of contact person
1st name Fumimasa
Middle name
Last name Fukuta
Organization Sapporo medical university school of medicine
Division name the department of urology
Zip code 060-8543
Address Minami 1 Jo Nishi 16 Chome, Chuo-ku, Sapporo-shi
TEL 011-611-2111
Homepage URL
Email ffukuta@sapmed.ac.jp

Sponsor
Institute Sapporo medical university
Institute
Department

Funding Source
Organization nothing
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization sapporo medical university IRB
Address south1, west16, chuo-ku, sapporo
Tel 0116112111
Email no Email

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 札幌医科大学付属病院(北海道)、NTT東日本病院(北海道)、函館五稜郭病院(北海道)、王子総合病院(北海道)、製鉄記念室蘭病院(北海道)、市立室蘭総合病院(北海道)、倶知安厚生病院(北海道)、砂川市立病院(北海道)、旭川赤十字病院(北海道)、滝川市立病院(北海道)、帯広協会病院(北海道)、JCHO北海道病院(北海道)

Other administrative information
Date of disclosure of the study information
2017 Year 06 Month 20 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
2017 Year 04 Month 24 Day
Date of IRB
2017 Year 08 Month 09 Day
Anticipated trial start date
2017 Year 06 Month 26 Day
Last follow-up date
2022 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information multi center prospective study

Management information
Registered date
2017 Year 06 Month 20 Day
Last modified on
2019 Year 06 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031880

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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