UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003937 |
|---|---|
| Receipt number | R000004736 |
| Scientific Title | Prospective Multi-institutional Observation Study of Charged Particle Radiation Therapy for Patients with Prostate Cancer |
| Date of disclosure of the study information | 2010/08/01 |
| Last modified on | 2016/11/01 14:07:28 |
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Basic information
Public title
Prospective Multi-institutional Observation Study of Charged Particle Radiation Therapy for Patients with Prostate Cancer
Acronym
Multi-institutional Study of Charged Particle Radiation Therapy for Prostate Cancer
Scientific Title
Prospective Multi-institutional Observation Study of Charged Particle Radiation Therapy for Patients with Prostate Cancer
Scientific Title:Acronym
Multi-institutional Study of Charged Particle Radiation Therapy for Prostate Cancer
Region
| Japan |
Condition
Condition
Prostate cancer
Classification by specialty
| Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate efficacy and safety of charged particle (carbon ion and proton) radiotherapy for prostate cancer, by common protocol among multiple institutions
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
relapse-free survival rate
Key secondary outcomes
overall survival rate
incidence of radiation toxicity
quality of life
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male
Key inclusion criteria
1)pathologically confirmed prostate cancer
2)previously untreated or receiving hormone therapy within 12 months and possible to record sufficient medical informations for analysis
3)clinical stage T1-T3N0M0
4)written informed consent
Key exclusion criteria
1)re-elevation of serum prostate specific antigen (PSA) after start of hormone therapy
2)impossible to refer pathological specimen
3)active concurrent malignancy
4)other medical or psychological reasons for exclusion
Target sample size
656
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tadashi Kamada |
Organization
National Institute of Radiological Sciences
Division name
Research Center for Charged Particle Therapy
Zip code
Address
4-9-1 Anagawa, Inage-ku, Chiba 263-8555
TEL
043-206-3350
kamada.tadashi@qst.go.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiroshi Tsuji |
Organization
National Institute of Radiological Sciences
Division name
Research Center for Charged Particle Therapy
Zip code
Address
4-9-1 Anagawa, Inage-ku, Chiba 263-8555
TEL
043-206-3350
Homepage URL
h_tsuji@nirs.go.jp
Sponsor or person
Institute
National Institute of Radiological Sciences
Institute
Department
Personal name
Funding Source
Organization
Japanese Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
放射線医学総合研究所（千葉県）、群馬大学（群馬県）、国立がんセンター東病院（千葉県）、静岡がんセンター（静岡県）、兵庫県粒子線医療センター（兵庫県）、筑波大学（茨城県）、若狭湾エネルギー研究センター（福井県）、南東北病院（福島県）
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 08 | 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
No longer recruiting
Date of protocol fixation
| 2010 | Year | 07 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 07 | Month | 01 | Day |
Date of closure to data entry
| 2018 | Year | 07 | Month | 01 | Day |
Date trial data considered complete
| 2018 | Year | 07 | Month | 01 | Day |
Date analysis concluded
| 2019 | Year | 03 | Month | 01 | Day |
Other
Other related information
Comparative analysis with results of historically or simultaneously performed studies of X-ray radiotherapy, brachytherapy, or surgery will be carried out.
In addition, comparative analysis between carbon ion and proton will be performed.
Management information
Registered date
| 2010 | Year | 07 | Month | 22 | Day |
Last modified on
| 2016 | Year | 11 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004736
| Research Plan | |
|---|---|
| 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 |
