UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006400 |
|---|---|
| Receipt number | R000007596 |
| Scientific Title | Preliminary study of selective estrogen modulators (SERMs) combined with maximum androgen blockade for metastatic prostate cancer |
| Date of disclosure of the study information | 2011/09/25 |
| Last modified on | 2017/03/28 13:49:09 |
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Basic information
Public title
Preliminary study of selective estrogen modulators (SERMs) combined with maximum androgen blockade for metastatic prostate cancer
Acronym
SERMs for metastatic PCA
Scientific Title
Preliminary study of selective estrogen modulators (SERMs) combined with maximum androgen blockade for metastatic prostate cancer
Scientific Title:Acronym
SERMs for metastatic PCA
Region
| Japan |
Condition
Condition
Bone metastatic prostate cancer
Classification by specialty
| Urology | Adult |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The aim of study is to evaluate the efficacy of selective estrogen modulators (SERMs) combined with maximum androgen blockade for the treatment with metastatic prostate cancer.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
PSA-relapse-free survival
Key secondary outcomes
VAS, and QOL
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
androgen deprivation therapy
Interventions/Control_2
raloxifene
Interventions/Control_3
toremifene
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
prostate cancer diagnosed by prostate biopsy, Over 20 years old male with bone metastasis confirmed CT scan or bone scintigraphy, written informed consent
Key exclusion criteria
Liver dysfunction, thrombosis, using bisphosphonate, warfarin, phenobarbital, rifampicin, or ampicillin. Urinary tract infection, mental disease, the patients decided not applicable for this study by physician
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tetsuya Fujimura |
Organization
the University of Tokyo
Division name
Department of Urology
Zip code
Address
7-3-1, Hongo, Bunkyo-ku
TEL
03-3815-5411
fujimurat-uro@h.u-tokyo.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tetsuya Fujimura |
Organization
the University of Tokyo
Division name
Department of Urology
Zip code
Address
7-3-1, Hongo, Bunkyo-ku
TEL
0338155411
Homepage URL
http://www.h.u-tokyo.ac.jp/urology/
fujimurat-uro@h.u-tokyo.ac.jp
Sponsor or person
Institute
the University of Tokyo
Institute
Department
Personal name
Funding Source
Organization
the University of Tokyo
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
| 2011 | Year | 09 | Month | 25 | 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
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
| 2009 | Year | 09 | Month | 14 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 05 | Month | 07 | Day |
Last follow-up date
Date of closure to data entry
| 2016 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2011 | Year | 09 | Month | 23 | Day |
Last modified on
| 2017 | Year | 03 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007596
