UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027832 |
|---|---|
| Receipt number | 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 | 2023/12/25 14:14:10 |
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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 | Kou |
| Middle name | |
| Last name | Kobayashi |
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
ffukuta@sapmed.ac.jp
Public contact
Name of contact person
| 1st name | Kou |
| Middle name | |
| Last name | Kobayashi |
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
ffukuta@sapmed.ac.jp
Sponsor or person
Institute
Sapporo medical university
Institute
Department
Personal name
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
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
27
Results
Results date posted
| 2021 | Year | 12 | Month | 23 | Day |
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
No longer 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
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
| 2023 | Year | 10 | Month | 01 | Day |
Date analysis concluded
| 2024 | Year | 04 | Month | 01 | Day |
Other
Other related information
This is multicenter prospective study.
At present, 27 cases have been registered.
Follow-up was completed for all cases.
Currentry, we are collecting and analyzing data from each facility.
Management information
Registered date
| 2017 | Year | 06 | Month | 20 | Day |
Last modified on
| 2023 | Year | 12 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031880
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
