UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047981 |
|---|---|
| Receipt number | R000051908 |
| Scientific Title | Effect of tadarafil on lower urinary tract symptoms in patients treated with low dose rate brachytherapy for prostate cancer |
| Date of disclosure of the study information | 2022/06/10 |
| Last modified on | 2024/12/09 13:20:46 |
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Basic information
Public title
Effect of tadarafil on lower urinary tract symptoms in patients treated with low dose rate brachytherapy for prostate cancer
Acronym
TABRAP study
Scientific Title
Effect of tadarafil on lower urinary tract symptoms in patients treated with low dose rate brachytherapy for prostate cancer
Scientific Title:Acronym
TABRAP study
Region
| Japan |
Condition
Condition
Prostate cancer
Classification by specialty
| Urology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the additional effects of mirabegron to alpha-1 adrenergic antagonist on lower urinary tract symptoms of patients who underwent 125I-brachytherapy for prostate cancer
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The change in mean 24-hour urinary frequency for 3 days at 3 months after I125 brachytherapy from baseline
Key secondary outcomes
The changes in IPSS, OABSS, and EPIC score; post-voiding residual urine; and mean volume voided per micturition from baseline at 3 months after I125 brachytherapy urinary frequency for 3 days at 1 month and 3 months after I125 brachytherapy from baseline
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Silodosin
Interventions/Control_2
Silodosin plus Tadalafil
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
| 20 | years-old | <= |
Age-upper limit
| 80 | years-old | > |
Gender
Male
Key inclusion criteria
1, cT1-T3aN0M0 prostate cancer diagnosed by prostate biopsy, technetium-99 m [99 m-Tc] bone scans, computed tomography, and magnetic resonance imaging
2, Adult men aged 20-80 years
3, Performance Status 0-2
4, Men who undergo 125I-brachytherapy for prostate cancer
5, Prostate volume > 15mL based on MRI before treatment
Key exclusion criteria
1 Patients who take nitric acid agents
2 Allergy to tadalafil
3 Unstable angina
4 Heart failure NYHA3 or more
5 Uncontrolled arrhythmia or hypotension
6 Myocardial infarction within 3 months
7 Cerebral infarction or hemorrhage within 6 months
8 Patients who take PDE 5 inhibitor
9 Ineligibility judged by the investigator due to medical, psychological or other reason
Target sample size
220
Research contact person
Name of lead principal investigator
| 1st name | Yasushi |
| Middle name | |
| Last name | Nakai |
Organization
Nara Medical University
Division name
Department of Urology
Zip code
634-0006
Address
Kashihara
TEL
0744240345
nakaiyasusiuro@live.jp
Public contact
Name of contact person
| 1st name | Yasushi |
| Middle name | |
| Last name | Nakai |
Organization
Nara Medical University
Division name
Department of Urology
Zip code
634-0006
Address
Kashihara
TEL
0744240345
Homepage URL
nakaiyasusiuro@live.jp
Sponsor or person
Institute
Nara Medical University
Institute
Department
Personal name
Funding Source
Organization
Nara Medical University
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
Nara Medical University
Address
840 Shijyocho, Kashihara, Nara, Japan
Tel
0744223051
ino_rinri@naramed-u.ac.jp
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
| 2022 | Year | 06 | Month | 10 | 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
No longer recruiting
Date of protocol fixation
| 2022 | Year | 05 | Month | 27 | Day |
Date of IRB
| 2022 | Year | 05 | Month | 27 | Day |
Anticipated trial start date
| 2022 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 06 | Month | 08 | Day |
Last modified on
| 2024 | Year | 12 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051908
