UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011500 |
|---|---|
| Receipt number | R000013452 |
| Scientific Title | Brachytherapy using linked-seed for prostate cancer with one intermediate risk factor -multicenter phase I/II trial- |
| Date of disclosure of the study information | 2013/08/16 |
| Last modified on | 2020/08/05 07:43:09 |
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Basic information
Public title
Brachytherapy using linked-seed for prostate cancer with one intermediate risk factor -multicenter phase I/II trial-
Acronym
Linked-seed brachytherapy for prostate cancer with one intermediate risk factor
Scientific Title
Brachytherapy using linked-seed for prostate cancer with one intermediate risk factor -multicenter phase I/II trial-
Scientific Title:Acronym
Linked-seed brachytherapy for prostate cancer with one intermediate risk factor
Region
| Japan |
Condition
Condition
Prostate cancer
Classification by specialty
| Urology | Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To test whether brachytherapy is applicable to the patients with prostate cancer with only one intermediate risk factor
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Phase I,II
Assessment
Primary outcomes
2-year late adverse event (genitourinary and gastrointestinal Grade 2 or more)
Key secondary outcomes
2-year PSA failure-free rate, QOL survey (EPIC + SF8), dosimetry (radiation physics including dose districution)
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| 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
| 20 | years-old | <= |
Age-upper limit
| 80 | years-old | > |
Gender
Male
Key inclusion criteria
Patients with only one factor of the following three intermediate risk factors:
1) 10 <= PSA <20
2) Gleason score = 7
3) T2b-T2c (2009 UICC)
Key exclusion criteria
1) active other cancer
2) uncontrollable diabetes millitus
3) ubable to stop anticoagulation drug
4) significant psycologic disease
5) collagen disease
6) judged as inappropriate by the dedicated physician
Target sample size
25
Research contact person
Name of lead principal investigator
| 1st name | Takero |
| Middle name | |
| Last name | Hirata |
Organization
Osaka University Graduate School of Medicine
Division name
Radiation Oncology
Zip code
5650871
Address
2-2 Yamadaoka, Suita
TEL
06-6879-3482
hirata@radonc.med.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | Takero |
| Middle name | |
| Last name | Hirata |
Organization
Osaka University Graduate School of Medicine
Division name
Radiation Oncology
Zip code
5650871
Address
2-2 Yamadaoka, Suita
TEL
06-6879-5600
Homepage URL
hirata@radonc.med.osaka-u.ac.jp
Sponsor or person
Institute
Osaka University Graduate School of Medicine,
Radiation Oncology
Institute
Department
Personal name
Funding Source
Organization
None
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
Osaka University Clinical Research Review Committee
Address
2-15 Yamadaoka, Suita, Osaka
Tel
06-6879-5111
mori@hp-crc.med.osaka-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
| 2013 | Year | 08 | Month | 16 | 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
No longer recruiting
Date of protocol fixation
| 2013 | Year | 07 | Month | 03 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 08 | Month | 15 | Day |
Last follow-up date
| 2020 | Year | 02 | Month | 29 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2013 | Year | 08 | Month | 16 | Day |
Last modified on
| 2020 | Year | 08 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013452
| Research Plan | |
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| 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 |
