UMIN-CTR Clinical Trial

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