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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000035606
Receipt No. R000040049
Scientific Title A prospective cohort study of hypofractionated radiotherapy using 60Gy in 20 fractions for prostate cancer with IMRT/IGRT
Date of disclosure of the study information 2019/01/22
Last modified on 2019/01/21

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Basic information
Public title A prospective cohort study of hypofractionated radiotherapy using 60Gy in 20 fractions for prostate cancer with IMRT/IGRT
Acronym A prospective cohort study of hypofractionated RT for prostate cancer
Scientific Title A prospective cohort study of hypofractionated radiotherapy using 60Gy in 20 fractions for prostate cancer with IMRT/IGRT
Scientific Title:Acronym A prospective cohort study of hypofractionated RT for prostate cancer
Region
Japan

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

Objectives
Narrative objectives1 The purpose of this study is to evaluate the efficacy and toxicity of hypofractionated intensity-modulated radiation therapy (IMRT) with image-guided radiation therapy (IGRT) for prostate cancer.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Five-year 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
20 years-old <=
Age-upper limit

Not applicable
Gender Male
Key inclusion criteria 1) Primary adenocarcinoma of the prostate
2) T1c-T3bN0M0 (UICC TNM 8th Edition)
3) Age >= 20 years old
4) ECOG-PS 0-2
5) No previous pelvic radiotherapy
6) Fiducial marker guided prostate radiotherapy can be used
7) Written informed consent
Key exclusion criteria 1) Treated with brachytherapy
2) Received anti-androgen therapy for more than 1 year
3) After radical prostatectomy
4) Inflammatory bowel disease
5) Bilateral total hip arthroplasty
6) Synchronous or metachronous malignancies
7) Patients who attending physicians consider to be inappropriate due to other reasons mentioned above
Target sample size 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hisanori Ariga
Organization Iwate medical university
Division name Department of radiation oncology
Zip code
Address 19-1, Uchimaru, Morioka, Iwate
TEL 019-651-5111
Email hariga2525@gmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Koyo Kikuchi
Organization Iwate medical university
Division name Department of radiation oncology
Zip code
Address 19-1, Uchimaru, Morioka, Iwate
TEL 019-651-5111
Homepage URL
Email kikuchi@iwate-med.ac.jp

Sponsor
Institute Iwate medical university
Institute
Department

Funding Source
Organization Iwate medical university
Organization
Division
Category of Funding Organization Self funding
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
2019 Year 01 Month 22 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 Preinitiation
Date of protocol fixation
2019 Year 01 Month 21 Day
Date of IRB
Anticipated trial start date
2019 Year 01 Month 22 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information N/A

Management information
Registered date
2019 Year 01 Month 21 Day
Last modified on
2019 Year 01 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040049

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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