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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000012780
Receipt No. 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

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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
Email 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
Email yoshioka-noriko@naramed-u.ac.jp

Sponsor
Institute Department of Urology, Nara Medical University
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014854

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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