UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044289 |
|---|---|
| Receipt number | 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 | 2022/05/23 09:32:36 |
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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
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
miyaji@med.kawasaki-m.ac.jp
Sponsor or person
Institute
Kawasaki Medical School Hospita, Department of Urology
Institute
Department
Personal name
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
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
Suspended
Date of protocol fixation
| 2021 | Year | 05 | Month | 21 | Day |
Date of IRB
| 2021 | Year | 08 | Month | 06 | Day |
Anticipated trial start date
| 2021 | Year | 08 | Month | 06 | 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
| 2022 | Year | 05 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050590
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| Registered date | File name |
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