UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025921 |
|---|---|
| Receipt number | R000029806 |
| Scientific Title | A multi-institutional clinical trial of carbon-ion radiotherapy for localized high-risk prostate cancer |
| Date of disclosure of the study information | 2017/02/25 |
| Last modified on | 2025/02/05 13:22:12 |
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Basic information
Public title
A multi-institutional clinical trial of carbon-ion radiotherapy for localized high-risk prostate cancer
Acronym
Carbon-ion radiotherapy for localized high-risk prostate cancer
Scientific Title
A multi-institutional clinical trial of carbon-ion radiotherapy for localized high-risk prostate cancer
Scientific Title:Acronym
Carbon-ion radiotherapy for localized high-risk prostate cancer
Region
| Japan |
Condition
Condition
Prostate Cancer
Classification by specialty
| Urology | Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Objective is to evaluate efficacy of carbon-ion radiotherapy for localized high-risk prostate cancer.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Phase II
Assessment
Primary outcomes
5-year biochemical recurrence free survival
Key secondary outcomes
late toxicity (gastrointestinal, genitourinary), 5-year overall survival, 5-year cause specific survival, cost effectiveness, quality of life
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
| Device,equipment |
Interventions/Control_1
51.6Gy(RBE) of carbon-ion radiation in 12 fractions, 1 fraction per day, 4.3Gy(RBE) per fraction.
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
1) Histologicaly proven prostate cancer other than ductal carcinoma.
2) cT3a (UICC 7th Edition) or initial PSA>20ng/ml or Gleason score sum >=8
3) No apparent lymph node or distant metastasis confirmed by diagnostic imaging.
4) Performed neoadjuvant androgen deprivation therapy to be 3 to 12 months.
5) Performance status 0-2 (ECOG)
6) Written consent to be enrolled in this study.
Key exclusion criteria
1) Existence of any treatment, excluding androgen deprivation therapy for prostate cancer.
2) Past history of radiotherapy which interferes with the study treatment.
3) Existence of other active malignancies (any co-existing malignancies and history of malignancy within 2 years). in-situ lesions which are concluded to be cured are not considered as such.
4) Uncontrolled infection and inflammatory disease within the irradiation field of the study treatment.
5) Psychologically and/or medically unfit for trial decided by an attending physician.
Target sample size
156
Research contact person
Name of lead principal investigator
| 1st name | Kana |
| Middle name | |
| Last name | Kobayashi |
Organization
National Institutes for Quantum Science and Technology
Division name
QST Hospital
Zip code
263-8555
Address
4-9-1 Anagawa Inage, Chiba, JAPAN
TEL
043-206-3306
kobayashi.kanai@qst.go.jp
Public contact
Name of contact person
| 1st name | Kana |
| Middle name | |
| Last name | Kobayashi |
Organization
National Institutes for Quantum Science and Technology
Division name
QST Hospital
Zip code
263-8555
Address
4-9-1 Anagawa Inage, Chiba, JAPAN
TEL
043-206-3306
Homepage URL
kobayashi.kanai@qst.go.jp
Sponsor or person
Institute
National Institutes for Quantum Science and Technology
Institute
Department
Personal name
Funding Source
Organization
National Institutes for Quantum Science and Technology
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Institutes for Quantum Science and Technology Certified Review Board
Address
4-9-1 Anagawa Inage, Chiba, JAPAN
Tel
043-206-4706
helsinki@qst.go.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
QST 病院(千葉県)
群馬大学 重粒子線医学研究センター(群馬県)
神奈川県立がんセンター(神奈川県)
九州国際重粒子線がん治療センター(佐賀県)
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 02 | Month | 25 | 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
156
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
| 2017 | Year | 02 | Month | 18 | Day |
Date of IRB
| 2017 | Year | 02 | Month | 15 | Day |
Anticipated trial start date
| 2017 | Year | 02 | Month | 25 | Day |
Last follow-up date
| 2024 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 01 | Month | 31 | Day |
Last modified on
| 2025 | Year | 02 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029806
