UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000025453 |
|---|---|
| Receipt number | 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 | 2026/11/09 14:19:36 |
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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 | Hideyuki |
| Middle name | |
| Last name | Sakurai |
Organization
University of Tsukuba, Faculty of Medicine
Division name
Radiation Oncology
Zip code
305-8576
Address
1-1-1, Tennodai, Tsukuba, Ibaraki
TEL
0298537100
hsakurai@pmrc.tsukuba.ac.jp
Public contact
Name of contact person
| 1st name | Masashi |
| Middle name | |
| Last name | Mizumoto |
Organization
University of Tsukuba, Faculty of Medicine
Division name
Proton Medical Research Center
Zip code
305-8576
Address
1-1-1, Tennodai, Tsukuba, Ibaraki
TEL
0298537100
Homepage URL
mizumoto@pmrc.tsukuba.ac.jp
Sponsor or person
Institute
University of Tsukuba
Institute
Department
Personal name
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
Ethical Committee, University of Tsukuba Hospital
Address
2-1-1 Amakubo Tsukuba Ibaraki Japan
Tel
0298533749
rinshokenkyu@un.tsukuba.ac.jp
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
名古屋市立大学医学部附属西部医療センター（愛知県）
筑波大学附属病院（茨城県）
相澤病院（長野県）
静岡県立静岡がんセンター（静岡県）
国立がん研究センター東病院（千葉県）
兵庫県立粒子線医療センター（兵庫県）
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）
兵庫県立粒子線医療センター附属神戸陽子線センター（兵庫県）
北海道大学病院（北海道）
福井県立病院（福井県）
津山中央病院（岡山県）
京都府立医科大学附属病院（京都府）
札幌禎心会病院（北海道）
大阪陽子線クリニック（大阪府）
高井病院（奈良県）
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 03 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
205
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
| 2016 | Year | 12 | Month | 21 | Day |
Date of IRB
| 2015 | Year | 12 | Month | 30 | Day |
Anticipated trial start date
| 2017 | Year | 12 | Month | 26 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2026 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2026 | Year | 04 | Month | 22 | Day |
Date analysis concluded
| 2026 | Year | 05 | Month | 15 | Day |
Other
Other related information
Management information
Registered date
| 2016 | Year | 12 | Month | 28 | Day |
Last modified on
| 2026 | Year | 11 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029289
