UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005288 |
|---|---|
| Receipt number | R000006287 |
| Scientific Title | Dutasteride for biopsy-negative benign prostate hyperplasia - effects on cancer detection and aging male symptoms |
| Date of disclosure of the study information | 2011/03/22 |
| Last modified on | 2013/01/07 21:09:35 |
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Basic information
Public title
Dutasteride for biopsy-negative benign prostate hyperplasia - effects on cancer detection and aging male symptoms
Acronym
Dutasteride for biopsy-negative benign prostate hyperplasia - effects on cancer detection and aging male symptoms
Scientific Title
Dutasteride for biopsy-negative benign prostate hyperplasia - effects on cancer detection and aging male symptoms
Scientific Title:Acronym
Dutasteride for biopsy-negative benign prostate hyperplasia - effects on cancer detection and aging male symptoms
Region
| Japan |
Condition
Condition
biopsy-negative benign prostate hyperplasia
Classification by specialty
| Urology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Cancer detection and lower urinary tract symptoms by intake of dutasteride will be examined in patients with high levels of PSA without prostate cancer.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Cancer detection by prostatic biopsy
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Medicine |
Interventions/Control_1
dutasteride 0.5mg
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
1. age >=40
2. Written informed consent
3. serum PSA levels >=4.0
4. Patients without prostate cancer
5. Patients with benign prostatic hyperplasia
Key exclusion criteria
1) patients with prostate cancer
2) patients with previous operation on prostate
3) Subjects taking any anti-androgen drugs
4) patients with prostatitis
5) Subjects with active urinary infection
6) Subjects with urethral catheter
7) Subjects with irritation to Eviprostat
8) Severe renal dysfunction
9) Severe liver dysfunction
10) Other ineligible subjects
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroshi Fukuhara |
Organization
University of Tokyo Hospital
Division name
Department of Uology
Zip code
Address
7-3-1 Hongo, Bunkyo-ku Tokyo
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiroshi Fukuhara |
Organization
University of Tokyo Hospital
Division name
Department of Uology
Zip code
Address
7-3-1 Hongo, Bunkyo-ku Tokyo
TEL
Homepage URL
Sponsor or person
Institute
Department of Urology, University of Tokyo Hospital
Institute
Department
Personal name
Funding Source
Organization
Department of Urology, University of Tokyo Hospital
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2011 | Year | 03 | Month | 22 | 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
Completed
Date of protocol fixation
| 2011 | Year | 03 | Month | 02 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 06 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2011 | Year | 03 | Month | 22 | Day |
Last modified on
| 2013 | Year | 01 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006287
