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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000025453
Receipt No. R000029289
Scientific Title A multi-institutional clinical trial of proton beam therapy for localized intermediate-risk prostate cancer
Date of disclosure of the study information 2017/03/01
Last modified on 2019/07/03

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Basic information
Public title A multi-institutional clinical trial of proton beam therapy for
localized intermediate-risk prostate cancer
Acronym A multi-institutional clinical trial of proton beam therapy for
localized intermediate-risk prostate cancer
Scientific Title A multi-institutional clinical trial of proton beam therapy for
localized intermediate-risk prostate cancer
Scientific Title:Acronym A multi-institutional clinical trial of proton beam therapy for
localized intermediate-risk prostate cancer
Region
Japan

Condition
Condition localized intermediate-risk prostate cancer
Classification by specialty
Urology Radiology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the efficacy and feasibility of proton beam radiation therapy for intermediate-risk prostate cancer
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes 5-year biochemical relapse-free survival rate
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 Proton beam radiation therapy (63 GyE)
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
75 years-old >=
Gender Male
Key inclusion criteria Pathology: Adenocarcinoma
No LN/distant metastasis
KPS: 70 or more and estimated 5-year survival
Androgen deprivation therapy: 6-8 months
A written informed consent
Key exclusion criteria Previous prostate cancer treatment: surgery, HIFU, chemotherapy, and others
Other cancers within 5 years
History of radiation therapy for pelvis
Uncontrolled infection or DM
more than 135 Kg

Target sample size 200

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, Ibaraki
TEL 0298537100
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 Proton Medical Research Center
Zip code
Address 1-1-1, Tennodai, Tsukuba, Ibaraki
TEL 0298537100
Homepage URL
Email hishikawa@pmrc.tsukuba.ac.jp

Sponsor
Institute University of Tsukuba
Institute
Department

Funding Source
Organization Japan Agency for Medical Research and Development
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 北海道大学病院(北海道)
相澤病院(長野県)
脳神経疾患研究所附属南東北がん陽子線治療センター(福島県)
静岡県立静岡がんセンター(静岡県)
名古屋市立西部医療センター(愛知県)
福井県立病院(福井県)
メディポリス国際陽子線治療センター(鹿児島県)
津山中央病院(岡山県)
札幌禎心会病院(北海道)
大阪陽子線クリニック(大阪府)

Other administrative information
Date of disclosure of the study information
2017 Year 03 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
2016 Year 12 Month 21 Day
Date of IRB
Anticipated trial start date
2017 Year 12 Month 26 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 12 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=R000029289

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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