UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015767 |
|---|---|
| Receipt number | R000018348 |
| Scientific Title | The role of tadalafil for lower urinary tract symptoms after brachytherapy |
| Date of disclosure of the study information | 2014/12/01 |
| Last modified on | 2014/11/28 00:25:20 |
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Basic information
Public title
The role of tadalafil for lower urinary tract symptoms after brachytherapy
Acronym
Tadalafil after brachytherapy
Scientific Title
The role of tadalafil for lower urinary tract symptoms after brachytherapy
Scientific Title:Acronym
Tadalafil after brachytherapy
Region
| Japan |
Condition
Condition
Prostatic cancer
Classification by specialty
| Urology | Radiology | Adult |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effect of tadalafil after brachytherapy for prostate cancer
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
International prostate symptom score
Overactive bladder score
Key secondary outcomes
Uroflowmetry (Qmax, Qave,Voided volume), residual urine, IIEF5, blood pressure, heart rate, complication (hematuria, rectal bleeding), blood test (PSA, total protein, albumin, hemoglobin, hematocrit)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Tadalafil 5mg, p.o.
Interventions/Control_2
Tamsulosin 0.2mg, p.o.
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
| 80 | years-old | > |
Gender
Male
Key inclusion criteria
Patients of prostate cancer, who received brachytherapy
Key exclusion criteria
1) Past history of urethral or prostatic surgery
2) Past history of radiation therapy for pelvic organs
3) History of severe neurogenic disorder of lower urinary tract including Parkinson disease, diabetes mellitus, etc..
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tomonori Minagawa |
Organization
Shinshu University Hospital
Division name
Urology
Zip code
Address
Asahi 3-1-1 Matsumoto city, 390-8621, Japan
TEL
0263372661
minagawat@shinshu-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tomonori Minagawa |
Organization
Shinshu University Hospital
Division name
Urology
Zip code
Address
Asahi 3-1-1 Matsumoto city, 390-8621, Japan
TEL
0263372661
Homepage URL
minagawat@shinshu-u.ac.jp
Sponsor or person
Institute
Department of Urology, Shinshu University Hospital
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
None
Name of secondary funder(s)
None
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
信州大学附属病院 (Shinshu University Hospital)
長野市民病院 (Nagano municipal hospital)
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 12 | 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
Preinitiation
Date of protocol fixation
| 2014 | Year | 10 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 01 | 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
| 2014 | Year | 11 | Month | 28 | Day |
Last modified on
| 2014 | Year | 11 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018348
| 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 |
