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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000044289
Receipt No. R000050590
Scientific Title The prospective study of focal high-dose rate brachytherapy for low or intermediate risk primary clinically localized prostate cancer
Date of disclosure of the study information 2021/06/01
Last modified on 2021/05/21

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Basic information
Public title The prospective study of focal high-dose rate brachytherapy for low or intermediate risk primary clinically localized prostate cancer
Acronym The prospective study of focal high-dose rate brachytherapy for low or intermediate risk prostate cancer
Scientific Title The prospective study of focal high-dose rate brachytherapy for low or intermediate risk primary clinically localized prostate cancer
Scientific Title:Acronym The prospective study of focal high-dose rate brachytherapy for low or intermediate risk primary clinically localized prostate cancer
Region
Japan

Condition
Condition Prostate cancer
Classification by specialty
Urology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 The efficacy and safety for focal high-dose rate brachytherapy using Irisium for low or intermediate localized prostate cancer
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase I,II

Assessment
Primary outcomes 1.The efficacy for the value of serum PSA and MRI
2.The efficacy for pathological evaluation of re-biopsy of focal radiation region
Key secondary outcomes The safety for focal high-dose rate brachytherapy using Irisium for clinically localized prostate cancer

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
Maneuver
Interventions/Control_1 Focal high-dose rate brachytherapy for Prostate cancer using Irisium-192, 19Gy single fraction
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
20 years-old <=
Age-upper limit

Not applicable
Gender Male
Key inclusion criteria 1.Prostate cancer diagnosed pathological examination
2.Only single region prostate cancer revealed same region, that suspcet of clinically significant cancer by mpMRI prior biopsy
3.Proatate cancer of Gleason score 3+3,3+4 or 4+3
4.Not ever accepte the therapy for prostate cancer
5.No metastasis region by radiological examination
6.PSA value less than 20ng/ml
7.Performance Status is 0, 1 or2
Key exclusion criteria 1.Prostate cancer region and size that unsuitable brachytherapy
2.multiple cancer region diagnosed by prostate biopsy
3.Medical history for radiation therapy of the pelvis
4.Unfit for regularly MRI examination for follow-up
5.Administration of glucocorticoid or 5-arufa reductase
6.Actively double cancer
Target sample size 20

Research contact person
Name of lead principal investigator
1st name Yoshiyuki
Middle name
Last name Miyaji
Organization Kawasaki Medical School Hospital
Division name Department of Urology
Zip code 701-0192
Address 577, Matsushima, Kurashiki, Japan
TEL 086-462-1111
Email miyaji@med.kawasaki-m.ac.jp

Public contact
Name of contact person
1st name Yoshiyuki
Middle name
Last name Miyaji
Organization Kawasaki Medical School Hospital
Division name Department of Urology
Zip code 701-0192
Address 577, Matsushima, Kurashiki, Japan
TEL 086-462-1111
Homepage URL
Email miyaji@med.kawasaki-m.ac.jp

Sponsor
Institute Kawasaki Medical School Hospita, Department of Urology
Institute
Department

Funding Source
Organization Kawasaki Medical School Hospita, Department of Urology
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 The ethics committee of Kawasaki Medical School and Hospital
Address 577, Matsushima, Kurashiki, Japan
Tel 086-462-1111
Email kmsrec@med.kawasaki-m.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 川崎医科大学附属病院(岡山県)

Other administrative information
Date of disclosure of the study information
2021 Year 06 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
2021 Year 05 Month 21 Day
Date of IRB
2021 Year 05 Month 26 Day
Anticipated trial start date
2021 Year 06 Month 15 Day
Last follow-up date
2026 Year 03 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
2021 Year 05 Month 21 Day
Last modified on
2021 Year 05 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050590

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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