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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000003937
Receipt No. R000004736
Official scientific title of the study 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

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Basic information
Official scientific title of the study Prospective Multi-institutional Observation Study of Charged Particle Radiation Therapy for Patients with Prostate Cancer
Title of the study (Brief title) 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 Tadashi Kamada
Organization National Institute of Radiological Sciences
Division name Research Center for Charged Particle Therapy
Address 4-9-1 Anagawa, Inage-ku, Chiba 263-8555
TEL 043-206-3350
Email kamada.tadashi@qst.go.jp

Public contact
Name of contact person Hiroshi Tsuji
Organization National Institute of Radiological Sciences
Division name Research Center for Charged Particle Therapy
Address 4-9-1 Anagawa, Inage-ku, Chiba 263-8555
TEL 043-206-3350
Homepage URL
Email h_tsuji@nirs.go.jp

Sponsor
Institute National Institute of Radiological Sciences
Institute
Department

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)

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

Progress
Recruitment status No longer recruiting
Date of protocol fixation
2010 Year 07 Month 01 Day
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

Related information
URL releasing protocol
Publication of results Unpublished
URL releasing results
Results
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004736

Research Plan
Registered date Registrant File name

Research case data specifications
Registered date Registrant File name

Research case data
Registered date Registrant File name


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