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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000015071
Receipt No. R000017534
Scientific Title Focal therapy with low dose rate brachytherapy for localized prostate cancer
Date of disclosure of the study information 2014/09/08
Last modified on 2019/12/02

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Basic information
Public title Focal therapy with low dose rate brachytherapy for localized prostate cancer
Acronym Focal brachytherapy for prostate cancer
Scientific Title Focal therapy with low dose rate brachytherapy for localized prostate cancer
Scientific Title:Acronym Focal brachytherapy for prostate cancer
Region
Japan

Condition
Condition Localized prostate cancer
Classification by specialty
Urology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the efficacy and safety of focal brachy therapy for locaized prostate cancer
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Phase II

Assessment
Primary outcomes adverse events, urinary function, sexial function, recurrence-free survival
Key secondary outcomes overall survival, disease-specific survival

Base
Study type Interventional

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 Treatment
Type of intervention
Device,equipment Maneuver
Interventions/Control_1 Brachytherapy
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
40 years-old <=
Age-upper limit

Not applicable
Gender Male
Key inclusion criteria 1) adenocarcinoma
2) prostate specific antigen 20 ng/ml or lower
Key exclusion criteria 1) poor performanse status
2) severe comorbidity
3) transurethralresection of prostatectomy(TURP)
Target sample size 200

Research contact person
Name of lead principal investigator
1st name Yasuhisa
Middle name
Last name Fujii
Organization Tokyo Medical and Dental University
Division name Urology
Zip code 113-8519
Address 1-5-45, Yushima, Bunkyo-ku, Tokyo
TEL 03-5803-5295
Email y-fujii.uro@tmd.ac.jp

Public contact
Name of contact person
1st name Yoh
Middle name
Last name Matsuoka
Organization Tokyo Medical and Dental University
Division name Urology
Zip code 113-8519
Address 1-5-45, Yushima, Bunkyo-ku, Tokyo
TEL 03-5803-5295
Homepage URL
Email yoh-m.uro@tmd.ac.jp

Sponsor
Institute Department of Urology, Tokyo Medical and Dental University
Institute
Department

Funding Source
Organization Department of Urology, Tokyo Medical and Dental 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 Tokyo Medical and Dental University
Address 1-5-45 Yushima, Bunkyo-ku, Tokyo
Tel 03-3813-6111
Email info.bec@tmd.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 09 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
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 Open public recruiting
Date of protocol fixation
2014 Year 09 Month 06 Day
Date of IRB
2014 Year 09 Month 06 Day
Anticipated trial start date
2014 Year 09 Month 06 Day
Last follow-up date
2029 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 09 Month 05 Day
Last modified on
2019 Year 12 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017534

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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