UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012780 |
|---|---|
| Receipt number | R000014854 |
| Scientific Title | Randomized control trial of post-dosimetric evaluation between monotherapy with loose seed and hybrid method in combination of strand seed in patients who undergo prostate brachytherapy |
| Date of disclosure of the study information | 2014/01/08 |
| Last modified on | 2019/07/24 08:10:01 |
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Basic information
Public title
Randomized control trial of post-dosimetric evaluation between monotherapy with loose seed and hybrid method in combination of strand seed in patients who undergo prostate brachytherapy
Acronym
Dosimetric Evaluation between Loose seed and Hybrid method of Prostate Brachytherapy (DELHPB trial)
Scientific Title
Randomized control trial of post-dosimetric evaluation between monotherapy with loose seed and hybrid method in combination of strand seed in patients who undergo prostate brachytherapy
Scientific Title:Acronym
Dosimetric Evaluation between Loose seed and Hybrid method of Prostate Brachytherapy (DELHPB trial)
Region
| Japan |
Condition
Condition
prostate cancer
Classification by specialty
| Urology | Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate postdosimetric parameter between monotherapy with loose seed and hybrid method in combination of strand seed in patients who undergo prostate brachytherapy
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
prostate dose (D90, V100, UD30, R100)
Key secondary outcomes
treatment time, seed migration
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
| Maneuver |
Interventions/Control_1
monotherapy with loose seed
Interventions/Control_2
Hybrid method in combination with starnd seed
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
| Not applicable |
Gender
Male
Key inclusion criteria
cT1-3aN0M0, PSA 50ng/mL or less
1. age: 20 years or greater
2. written informed consent
Key exclusion criteria
1. age: less than 20 years
2. inappropriate candidate judged by attending
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Nobumichi |
| Middle name | |
| Last name | Tanaka |
Organization
Nara Medical University
Division name
Urology
Zip code
634-8522
Address
Shijyocho 840, Kashihara, Nara
TEL
0744-22-3051
sendo@naramed-u.ac.jp
Public contact
Name of contact person
| 1st name | Noriko |
| Middle name | |
| Last name | Yoshioka |
Organization
Nara Medical University
Division name
ethical committee
Zip code
634-8522
Address
Shijyocho 840, Kashihara, Nara
TEL
0744-22-3051
Homepage URL
yoshioka-noriko@naramed-u.ac.jp
Sponsor or person
Institute
Department of Urology, Nara Medical University
Institute
Department
Personal name
Funding Source
Organization
Department of Urology, Nara Medical University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nara Medical University
Address
Shijyocho840, Kashihara, Nara
Tel
0744-22-3051
sendo@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
| 2014 | Year | 01 | Month | 08 | 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
220
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 | 09 | Month | 27 | Day |
Date of IRB
| 2013 | Year | 11 | Month | 05 | Day |
Anticipated trial start date
| 2014 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2017 | 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
| 2014 | Year | 01 | Month | 07 | Day |
Last modified on
| 2019 | Year | 07 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014854
| 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 |
