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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000006400
Receipt No. 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

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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
Email 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/
Email fujimurat-uro@h.u-tokyo.ac.jp

Sponsor
Institute the University of Tokyo
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007596

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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