UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033226 |
|---|---|
| Receipt number | R000037887 |
| Scientific Title | Multi-institutional, prospective study of a combination therapy with androgen deprivation and external beam radiation therapy for hormone-sensitive metastatic prostate cancer |
| Date of disclosure of the study information | 2018/07/09 |
| Last modified on | 2019/01/10 10:04:48 |
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Basic information
Public title
Multi-institutional, prospective study of a combination therapy with androgen deprivation and external beam radiation therapy for hormone-sensitive metastatic prostate cancer
Acronym
Multi-institutional, prospective study of a combination therapy with androgen deprivation and external beam radiation therapy for hormone-sensitive metastatic prostate cancer
Scientific Title
Multi-institutional, prospective study of a combination therapy with androgen deprivation and external beam radiation therapy for hormone-sensitive metastatic prostate cancer
Scientific Title:Acronym
Multi-institutional, prospective study of a combination therapy with androgen deprivation and external beam radiation therapy for hormone-sensitive metastatic prostate cancer
Region
| Japan |
Condition
Condition
Prostate cancer
Classification by specialty
| Urology |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
Impact of ADT and EBRT for hormone-sensitive prostate cancer
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Biochemical progression free survival
Key secondary outcomes
Overall survival
Clinical progression-free survival
Cancer specific survival
Quality of life
Adverse events
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Extra beam radiation therapy(EBRT); intervention of EBRT for the prostate from 3 to 6 months after androgen deprivation therapy
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
| 85 | years-old | >= |
Gender
Male
Key inclusion criteria
1, metastatic prostate cancer
2, StageIV,(TMN;Tany, N1 and/or M1)
3, Performance status 0-1(ECOG PS)
4, Age >= 20, <=85
Key exclusion criteria
1, Had a prior malignancy. (Any other cancer for which treatment has been completed >= 5 years is allowed).
2, Other pathological findings except for aciner adenocarcinoma.
3, Use of steroid agents
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kawamorita Naoki |
Organization
Tohoku University Hospital
Division name
Urology
Zip code
Address
1-1 Seiryo-machi Aobaku Sendai Miyagi Japan
TEL
022-717-7278
kawamorita@uro.med.tohoku.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kawamorita Naoki |
Organization
Tohoku University Hospital
Division name
Urology
Zip code
Address
1-1 Seiryo-machi Aobaku Sendai Miyagi Japan
TEL
022-717-7278
Homepage URL
kawamorita@uro.med.tohoku.ac.jp
Sponsor or person
Institute
Tohoku University
Institute
Department
Personal name
Funding Source
Organization
self funding
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
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
| 2018 | Year | 07 | Month | 09 | 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
Preinitiation
Date of protocol fixation
| 2018 | Year | 07 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 07 | Month | 09 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 07 | Month | 02 | Day |
Last modified on
| 2019 | Year | 01 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037887
