UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055941 |
|---|---|
| Receipt number | R000063927 |
| Scientific Title | Long-term treatment results of heavy ion radiotherapy for prostate cancer |
| Date of disclosure of the study information | 2024/10/30 |
| Last modified on | 2024/10/25 09:31:49 |
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Basic information
Public title
Long-term treatment results of heavy ion radiotherapy for prostate cancer
Acronym
Long-term treatment results of heavy ion radiotherapy for prostate cancer
Scientific Title
Long-term treatment results of heavy ion radiotherapy for prostate cancer
Scientific Title:Acronym
Long-term treatment results of heavy ion radiotherapy for prostate cancer
Region
| Japan |
Condition
Condition
prostate cancer
Classification by specialty
| Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To report the long-term results of heavy ion radiotherapy (CIRT) according to the re-risk classification of the NCCN classification for prostate cancer.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Overall survival rate, disease-specific survival rate, biochemical recurrence-free survival rate, adverse event rate
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
| 20 | years-old | <= |
Age-upper limit
| 100 | years-old | > |
Gender
Male
Key inclusion criteria
Patients who underwent heavy ion radiotherapy at our hospital from September 2007 to February 2013
Key exclusion criteria
Cases in which the secondary use of clinical data is refused when obtaining consent for treatment or other research, and cases in which the research subject or his/her representative refuses the use of clinical data in this research.
Target sample size
800
Research contact person
Name of lead principal investigator
| 1st name | KANA |
| Middle name | |
| Last name | KOBAYASHI |
Organization
National Institutes for Quantum Science and Technology (QST)
Division name
Dept. of Treatment and diagnosis
Zip code
263-8555
Address
4-9-1 Anakawa, Inage-ku, Chiba City, Chiba Prefecture
TEL
0432063306
kobayashi.kana@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
Dept. of Treatment and diagnosis
Zip code
263-8555
Address
4-9-1 Anakawa, Inage-ku, Chiba City, Chiba Prefecture
TEL
0432063306
Homepage URL
kobayashi.kana@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
Government offices of other countries
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)
Address
4-9-1 Anakawa, Inage-ku, Chiba City, Chiba Prefecture
Tel
0432063306
kobayashi.kana@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 | 10 | Month | 30 | 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
782
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 | 18 | Day |
Anticipated trial start date
| 2007 | Year | 09 | Month | 07 | Day |
Last follow-up date
| 2024 | Year | 05 | Month | 10 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Target cases will be extracted using QST Hospital's patient registration database system (AMIDAS). The following clinical data will be obtained from the same database system, medical records, PACS, and QOL questionnaire.
Clinical data: date of birth, date of treatment, Gleason Score, iPSA value, date of biopsy, number/proportion of positive cores at time of biopsy, details of hormone therapy, details of heavy ion radiotherapy, change in PSA value after treatment, local Analyze date of recurrence, date of PSA recurrence, date of distant metastasis recurrence, date of death or last observation date, presence or absence of additional treatment, adverse events and date of occurrence, treatment progress after recurrence, MRI and CT images before and after treatment, and QOL information.
Management information
Registered date
| 2024 | Year | 10 | Month | 25 | Day |
Last modified on
| 2024 | Year | 10 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063927
