UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000060067 |
|---|---|
| Receipt number | R000068277 |
| Scientific Title | Safety and Efficacy of Fiducial Marker and Hydrogel Spacer Placement in Carbon-Ion Radiotherapy for Prostate Cancer |
| Date of disclosure of the study information | 2025/12/12 |
| Last modified on | 2025/12/12 15:08:32 |
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Basic information
Public title
Safety and Efficacy of Fiducial Marker and Hydrogel Spacer Placement in Carbon-Ion Radiotherapy for Prostate Cancer
Acronym
Fiducial Marker and Hydrogel Spacer
Scientific Title
Safety and Efficacy of Fiducial Marker and Hydrogel Spacer Placement in Carbon-Ion Radiotherapy for Prostate Cancer
Scientific Title:Acronym
Safety and Efficacy of Fiducial Marker and Hydrogel Spacer Placement in Carbon-Ion Radiotherapy for Prostate Cancer
Region
| Japan |
Condition
Condition
prostate cancer
Classification by specialty
| Urology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate the safety of fiducial marker and hydrogel spacer placement in carbon-ion radiotherapy for prostate cancer.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Acute and late adverse events
Key secondary outcomes
5-year biochemical recurrence-free survival and 5-year overall survival
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male
Key inclusion criteria
Patients who underwent carbon-ion radiotherapy for prostate cancer at our institution between April 2018 and August 2025
Key exclusion criteria
Cases in which the patient or their representative refused the use of data for this study.
Cases with incomplete or missing data.
Target sample size
2500
Research contact person
Name of lead principal investigator
| 1st name | Atsushi |
| Middle name | |
| Last name | Okato |
Organization
National Institutes for Quantum Science and Technology, QST Hospital
Division name
Radiation Oncology Section
Zip code
263-8555
Address
4-9-1 Anagawa, Inage-ku, Chiba-shi, Chiba 263-8555, Japan
TEL
043-206-3306
okato.atsushi@qst.go.jp
Public contact
Name of contact person
| 1st name | Atsushi |
| Middle name | |
| Last name | Okato |
Organization
National Institutes for Quantum Science and Technology, QST Hospital
Division name
Radiation Oncology Section
Zip code
263-8555
Address
4-9-1 Anagawa, Inage-ku, Chiba-shi, Chiba 263-8555, Japan
TEL
043-206-3306
Homepage URL
okato.atsushi@qst.go.jp
Sponsor or person
Institute
National Institutes for Quantum Science and Technology, QST Hospital
Institute
Department
Personal name
Funding Source
Organization
National Institutes for Quantum Science and Technology, QST Hospital
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, QST Hospital
Address
4-9-1 Anagawa, Inage-ku, Chiba-shi, Chiba 263-8555, Japan
Tel
043-206-3306
okato.atsushi@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
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 12 | Month | 12 | 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
| 2025 | Year | 10 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 10 | Month | 10 | Day |
Last follow-up date
| 2030 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
none
Management information
Registered date
| 2025 | Year | 12 | Month | 12 | Day |
Last modified on
| 2025 | Year | 12 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068277
