UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044649 |
|---|---|
| Receipt number | R000050995 |
| Scientific Title | Multicenter prospective observational study on metastatic hormone-naive prostate cancer |
| Date of disclosure of the study information | 2021/06/24 |
| Last modified on | 2021/06/24 20:50:06 |
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Basic information
Public title
Multicenter prospective observational study on metastatic hormone-naive prostate cancer
Acronym
Multicenter prospective observational study on metastatic hormone-naive prostate cancer
Scientific Title
Multicenter prospective observational study on metastatic hormone-naive prostate cancer
Scientific Title:Acronym
Multicenter prospective observational study on metastatic hormone-naive prostate cancer
Region
| Japan |
Condition
Condition
metastatic hormone-naive prostate cancer
Classification by specialty
| Urology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the clinical outcomes of metastatic hormone-naive prostate cancer in Japan
Basic objectives2
Others
Basic objectives -Others
To evaluate the clinical practice of metastatic hormone-naive prostate cancer in Japan
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Clinical practice and outcomes of metastatic hormone-naive prostate cancer
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
Metastatic hormone naive prostate cancer
Key exclusion criteria
Patients for whom it is impossible to obtain consent
Target sample size
400
Research contact person
Name of lead principal investigator
| 1st name | Yasuhisa |
| Middle name | |
| Last name | Fujii |
Organization
Tokyo Medical and Dental University
Division name
Urology
Zip code
113-8519
Address
1-5-45 Yushima, Bunkyo-ku, Tokyo
TEL
03-5803-5295
ikyouro@tmd.ac.jp
Public contact
Name of contact person
| 1st name | Soichiro |
| Middle name | |
| Last name | Yoshida |
Organization
Tokyo Medical and Dental University
Division name
Urology
Zip code
Tokyo Medical and Dental University
Address
1-5-45 Yushima, Bunkyo-ku, Tokyo
TEL
03-5803-5295
Homepage URL
ikyouro@tmd.ac.jp
Sponsor or person
Institute
Tokyo Medical and Dental University
Institute
Department
Personal name
Funding Source
Organization
Tokyo Medical and Dental University
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
Tokyo Medical and Dental University
Address
1-5-45 Yushima, Bunkyo-ku, Tokyo
Tel
03-5803-5295
ikyouro@tmd.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
| 2021 | Year | 06 | Month | 24 | 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
Open public recruiting
Date of protocol fixation
| 2021 | Year | 04 | Month | 21 | Day |
Date of IRB
| 2021 | Year | 04 | Month | 28 | Day |
Anticipated trial start date
| 2021 | Year | 04 | Month | 28 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Prospective registration of clinical and pathological information obtained from medical records
Management information
Registered date
| 2021 | Year | 06 | Month | 24 | Day |
Last modified on
| 2021 | Year | 06 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050995
