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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000022570
Receipt No. R000026015
Scientific Title Phase II trial of hypofractionated intensity modulated radiotherapy in patients with low risk prostate cancer
Date of disclosure of the study information 2016/06/01
Last modified on 2020/12/10

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Basic information
Public title Phase II trial of hypofractionated intensity modulated radiotherapy in patients with low risk prostate cancer
Acronym HiMRT-P2
Scientific Title Phase II trial of hypofractionated intensity modulated radiotherapy in patients with low risk prostate cancer
Scientific Title:Acronym HiMRT-P2
Region
Japan

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

Objectives
Narrative objectives1 To examine the safety and efficacy of hypofractionated intensity modulated radiotherapy for localized prostate cancer
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Cumulative toxicity rate at 3 years after treatment
Key secondary outcomes

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
Other
Interventions/Control_1 radiotherapy
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

Not applicable
Gender Male
Key inclusion criteria pathological confirmation
<=T3bN0M0
age>=20 y.o.
PS=0 or 1
no history of pelvic irradiation
normal general condition
informed consent

Key exclusion criteria no psychological disease
no long term steroid prescription
severe diabetes mellitus
no active infection
Target sample size 55

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kasushige Hayakawa
Organization Kitasato University school of medicine
Division name department of radiology and radiation oncology
Zip code
Address 1-15-1 kitasato sagamiharashi-minamiku
TEL 042-778-8453
Email hayakaz@med.kitasato-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name hiromichi ishiyama
Organization kitasato university shool of medicine
Division name department of radiology and radiation oncology
Zip code
Address 1-15-1 kitasato sagamiharashi-minamiku
TEL 042-778-8453
Homepage URL
Email hishiyam@kitasato-u.ac.jp

Sponsor
Institute Kitasato university
Institute
Department

Funding Source
Organization na
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
2016 Year 06 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 55
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 Completed
Date of protocol fixation
2015 Year 11 Month 25 Day
Date of IRB
2015 Year 11 Month 25 Day
Anticipated trial start date
2015 Year 11 Month 26 Day
Last follow-up date
2021 Year 02 Month 15 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 06 Month 01 Day
Last modified on
2020 Year 12 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026015

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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