UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040693 |
|---|---|
| Receipt number | R000046446 |
| Scientific Title | Nationwide Japanese prostate cancer outcome study of permanent Iodine-125 seed implantation (J-POPS): Medical record-based longevity survey |
| Date of disclosure of the study information | 2020/06/10 |
| Last modified on | 2021/06/12 08:33:43 |
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Basic information
Public title
Nationwide Japanese prostate cancer outcome study of permanent Iodine-125
seed implantation (J-POPS): Medical record-based longevity survey
Acronym
J-POPS: Medical record-based longevity survey
Scientific Title
Nationwide Japanese prostate cancer outcome study of permanent Iodine-125
seed implantation (J-POPS): Medical record-based longevity survey
Scientific Title:Acronym
J-POPS: Medical record-based longevity survey
Region
| Japan |
Condition
Condition
prostate cancer
Classification by specialty
| Urology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate prognosis in patients who underwent 125I -brachytherapy for prostate cancer with long-term follow-up in Japan
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Overall survival
Key secondary outcomes
biochemical progression-free survival, Clinical progression-free survival, freedom from treatment failure, time to biochemical progression, time to clinical progression, disease-specific survival, metastasis-free survival,time to castration resistant prostate cancer
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
| Not applicable |
Gender
Male
Key inclusion criteria
Patients enrolled in Nationwide Japanese Prostate Cancer Outcome Study of Permanent Iodine-125 Seed Implantation
Key exclusion criteria
patients who offer refuse participation in this study
Target sample size
3000
Research contact person
Name of lead principal investigator
| 1st name | Tanaka |
| Middle name | |
| Last name | Nobumichi |
Organization
Nara Medical University
Division name
Department of Urology
Zip code
634-8521
Address
Shijyocho 840 Kashihara Nara
TEL
0744-22-3051
sendo@naramed-u.ac.jp
Public contact
Name of contact person
| 1st name | Nakai |
| Middle name | |
| Last name | Yasushi |
Organization
Nara Medical University
Division name
Department of Urology
Zip code
634-8521
Address
Shijyocho 840 Kashihara Nara
TEL
0744-22-3051
Homepage URL
nakaiyasushi@naramed-u.ac.jp
Sponsor or person
Institute
The Japanese Prostate Permanent Seed Implantation Study Group
Institute
Department
Personal name
Funding Source
Organization
The Japanese Prostate Permanent Seed Implantation Study Group
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
the ethics committee of Nara Medical university
Address
Shijyocho 840 Kashihara Nara
Tel
0744-22-3051
ino_rinri@naramed-u.ac.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
| 2020 | Year | 06 | Month | 10 | 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
Enrolling by invitation
Date of protocol fixation
| 2020 | Year | 04 | Month | 06 | Day |
Date of IRB
| 2020 | Year | 08 | Month | 28 | Day |
Anticipated trial start date
| 2020 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2030 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Status of health, treatment for prostate cancer, the kinds of treatment, the date of treatment, hospitalization, and death, cause of death, others
Management information
Registered date
| 2020 | Year | 06 | Month | 09 | Day |
Last modified on
| 2021 | Year | 06 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046446
