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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000033172
Receipt No. R000037830
Scientific Title A registry of Nation Japanese Radiation Oncology Study Group: Intensity-modulated radiation therapy for prostate cancer
Date of disclosure of the study information 2018/07/01
Last modified on 2019/07/03

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Basic information
Public title A registry of Nation Japanese Radiation Oncology Study Group: Intensity-modulated radiation therapy for prostate cancer
Acronym JROSG-IMRT-PC01
Scientific Title A registry of Nation Japanese Radiation Oncology Study Group: Intensity-modulated radiation therapy for prostate cancer
Scientific Title:Acronym JROSG-IMRT-PC01
Region
Japan

Condition
Condition Prostate cancer
Classification by specialty
Urology Radiology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To confirm the feasibility and efficacy of intensity-modulated radiation therapy for localized prostate cancer in Japan.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes 5-year rate of biochemical relapse free survival
Key secondary outcomes

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 Patients who
1)must be diagnosed as prostate cancer pathologically
2)have prostate adenocarinoma clinically staged with T1c-T4N0M0
3)must be at a score level of 70-100 of KPS; Karnofsky performance status
Key exclusion criteria Patients who
1)have existence of any treatment, excluding androgen deprivation therapy for prostate cancer.
2)have active double cancer (synchronous double cancer and metachronous double cancer within 5 disease-free years), excluding carcinoma in situ (lesions equal to intraepithelial or intramucosal cancer) judged to have been cured with local treatment.
3)have history of pelvis irradiation
Target sample size 1000

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hideyuki Sakurai
Organization University of Tsukuba, Faculty of Medicine
Division name Radiation Oncology
Zip code
Address 1-1-1, Tennodai, Tsukuba
TEL 029-853-7100
Email hsakurai@pmrc.tsukuba.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hitoshi Ishikawa
Organization University of Tsukuba, Faculty of Medicine
Division name Radiation Oncology
Zip code
Address 1-1-1, Tennodai, Tsukuba
TEL 029-853-7100
Homepage URL
Email hishikawa@pmrc.tsukuba.ac.jp

Sponsor
Institute University of Tsukuba
Institute
Department

Funding Source
Organization University of Tsukuba, Proton Medical Research Center
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
Address
Tel
Email

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
2018 Year 07 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 Open public recruiting
Date of protocol fixation
2018 Year 03 Month 30 Day
Date of IRB
Anticipated trial start date
2018 Year 06 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Comparative analysis with results of historically or simultaneously performed studies of proton beam therapy, carbon-ion beam therapy, or surgery will be carried out.

Management information
Registered date
2018 Year 06 Month 28 Day
Last modified on
2019 Year 07 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037830

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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