UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022530 |
|---|---|
| Receipt number | R000025969 |
| Scientific Title | Multi-institutional retrospective analysis of high-dose-rate brachytherapy combined with external beam radiotherapy for prostate cancer |
| Date of disclosure of the study information | 2016/05/30 |
| Last modified on | 2017/05/31 09:16:12 |
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Basic information
Public title
Multi-institutional retrospective analysis of high-dose-rate brachytherapy combined with external beam radiotherapy for prostate cancer
Acronym
Multi-institutional study of HDR combined with EBRT for prostate cancer
Scientific Title
Multi-institutional retrospective analysis of high-dose-rate brachytherapy combined with external beam radiotherapy for prostate cancer
Scientific Title:Acronym
Multi-institutional study of HDR combined with EBRT for prostate cancer
Region
| Japan | Asia(except Japan) |
Condition
Condition
prostate cancer
Classification by specialty
| Urology | Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
to report the results of prostate cancer patients treated with high-dose-rate brachytherapy combined with external beam radiotherapy
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
biochemical disease free survival
Key secondary outcomes
cumulative toxicity rate
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
na
Key exclusion criteria
na
Target sample size
3000
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | hiromichi ishiyama |
Organization
kitasato university school of medicine
Division name
department of radiology and radiation oncology
Zip code
Address
1-15-1 kitasato sagamiharashi-minamiku
TEL
042-778-8453
hishiyam@kitasato-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | hiromichi ishiyama |
Organization
kitasato university shool of medicine
Division name
department of radiology and radiation oncology
Zip code
Address
1-15-1 kitasato sagamiharashi-minamiku
TEL
042-778-8453
Homepage URL
hishiyam@kitasato-u.ac.jp
Sponsor or person
Institute
kitasato univerisity
Institute
Department
Personal name
Funding Source
Organization
Japanese Group of Brachytherapy-Japanese Society for Radiation Oncology
Japanese Radiation Oncology Study Group
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
Address
Tel
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
| 2016 | Year | 05 | Month | 30 | 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
Results
High-dose-rate brachytherapy combined with external beam radiotherapy was an effective and safe treatment for localized prostate cancer. Combination of long-term ADT was suggested to be necessary, even for HDR brachytherapy, and was useful in suppressing late toxicities. Meanwhile, pelvic irradiation was suggested to have an adverse effect on OS of our study population.
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
| 2015 | Year | 10 | Month | 21 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 10 | Month | 21 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
study design: multi-institutional retrospective analysis
Candidate: prostate cancer patients treated by high-dose-rate brachytherapy before 1995 and followed at least 2 years. Dead patients within 2 years are included.
Method: review of medical record.
Items: age, TNM stage, Gleason score, PSA value, history of TUR-p, with or without hormonal therapy, radiation dose, number of fractionations, type of external beam radiation therapy, follow up period, tumor control, survival period, toxicity rate
Management information
Registered date
| 2016 | Year | 05 | Month | 30 | Day |
Last modified on
| 2017 | Year | 05 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025969
