UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010585 |
|---|---|
| Receipt number | R000012368 |
| Scientific Title | Prostate cancer detection under PSA monitoring of dutasteride in patients with once negative biopsy and benign hyperplasia |
| Date of disclosure of the study information | 2013/06/01 |
| Last modified on | 2018/12/07 10:26:42 |
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Basic information
Public title
Prostate cancer detection under PSA monitoring of dutasteride in patients with once negative biopsy and benign hyperplasia
Acronym
Prostate cancer detection under PSA monitoring of dutasteride in patients with once negative biopsy and benign hyperplasia
Scientific Title
Prostate cancer detection under PSA monitoring of dutasteride in patients with once negative biopsy and benign hyperplasia
Scientific Title:Acronym
Prostate cancer detection under PSA monitoring of dutasteride in patients with once negative biopsy and benign hyperplasia
Region
| Japan |
Condition
Condition
Benign hyperplasia, prostate cancer
Classification by specialty
| Urology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Prostate cancer detection under PSA monitoring of dutasteride in patients with once negative biopsy and benign hyperplasia
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Detection of prostate cancer
Key secondary outcomes
Flucturation of PSA
Change of prostate volume
QOL
Adverse event
Base
Study type
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
Diagnosis
Type of intervention
| Medicine | Maneuver |
Interventions/Control_1
Oral administration of dutasteride for once negative biopsy patients and re-biopsy after begining of dutasteride for a year
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
| 60 | years-old | <= |
Age-upper limit
| 80 | years-old | > |
Gender
Male
Key inclusion criteria
PSA level of over than 4ng/ml
Men had one negative prostate biopsy
Men had a benign prostate hyperplasia including criteria of PV>30ml and IPSS>
8-points.
Key exclusion criteria
Men had a prostatis before a half of year
Men had surgery of prostate before enrollment
Men took dutasteride, finasteride, prostal which were reduced prostate volume.
Men had high grade intraepithelial neoplasia, atypical small acinar proliferation on one prostate biopsy
Men are inappropriately decided by a doctor
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tadashi Matsuda |
Organization
Kansai Medical University
Division name
The department of urology and andrology
Zip code
Address
2-3-1 Shin-machi Hirakata-shi Osaka city in Japan
TEL
072-804-0101
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takaaki Inoue |
Organization
Kansai Medical University
Division name
The department of urology and andrology
Zip code
Address
10-15 Moriguchi-shi Fumizono-tyou Osaka in Japan
TEL
06-6992-1001
Homepage URL
inouetak@hirakata.kmu.ac.jp
Sponsor or person
Institute
The department of urology and andrology in Kansai Medical University
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
The department of urology, Miyazaki University
The department of urology, Kyoto University
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
| 2013 | Year | 06 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
| 2013 | Year | 02 | Month | 23 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 06 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2013 | Year | 04 | Month | 24 | Day |
Last modified on
| 2018 | Year | 12 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012368
| Research Plan | |
|---|---|
| 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 |
