UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056245 |
|---|---|
| Receipt number | R000064050 |
| Scientific Title | Carbon Ion Radiotherapy for Prostate Cancer in Patients with a History of Surgery for Benign Prostatic Hyperplasia |
| Date of disclosure of the study information | 2024/11/22 |
| Last modified on | 2024/11/22 20:51:24 |
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Basic information
Public title
Carbon Ion Radiotherapy for Prostate Cancer in Patients with a History of Surgery for Benign Prostatic Hyperplasia
Acronym
Carbon Ion Radiotherapy for Prostate Cancer in Patients with a History of Surgery for Benign Prostatic Hyperplasia
Scientific Title
Carbon Ion Radiotherapy for Prostate Cancer in Patients with a History of Surgery for Benign Prostatic Hyperplasia
Scientific Title:Acronym
Carbon Ion Radiotherapy for Prostate Cancer in Patients with a History of Surgery for Benign Prostatic Hyperplasia
Region
| Japan |
Condition
Condition
prostate cancer
Classification by specialty
| Urology | Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
This study aims to investigate the long-term safety and efficacy and of carbon ion radiotherapy for prostate cancer patients with a history of BPH surgery.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Urologic Adverse Events
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male
Key inclusion criteria
Patients who underwent carbon ion radiotherapy for prostate cancer at our hospital between September 2007 and July 2024 and who had a history of prostate surgery for benign prostatic hyperplasia.
Key exclusion criteria
The cases in which the research subjects themselves refused the use of their data in this study.
Target sample size
60
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
Urology and Radiology
Zip code
263-8555
Address
4-9-1 Anagawa, Inage-ku, Chiba-shi
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
Urology and Radiology
Zip code
263-8555
Address
4-9-1 Anagawa, Inage-ku, Chiba-shi
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
Other
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 Institutional Review Board
Address
4-9-1 Anagawa Inage-ku, Chiba-shi
Tel
0432063306
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
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 11 | 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
70
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
No longer recruiting
Date of protocol fixation
| 2007 | Year | 09 | Month | 01 | Day |
Date of IRB
| 2024 | Year | 10 | Month | 08 | Day |
Anticipated trial start date
| 2007 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2029 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Retrospective observational study
Management information
Registered date
| 2024 | Year | 11 | Month | 22 | Day |
Last modified on
| 2024 | Year | 11 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064050
