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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000002792
Receipt No. R000003365
Scientific Title Multicenter comparative study to examine the efficacy of zoledronic acid in prostate cancer with bone metastasis at different hormone sensitivity status.
Date of disclosure of the study information 2009/11/26
Last modified on 2009/11/20

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Basic information
Public title Multicenter comparative study to examine the efficacy of zoledronic acid in prostate cancer with bone metastasis at different hormone sensitivity status.
Acronym Multicenter comparative study to examine the efficacy of zoledronic acid in prostate cancer with bone metastasis at different hormone sensitivity status.
Scientific Title Multicenter comparative study to examine the efficacy of zoledronic acid in prostate cancer with bone metastasis at different hormone sensitivity status.
Scientific Title:Acronym Multicenter comparative study to examine the efficacy of zoledronic acid in prostate cancer with bone metastasis at different hormone sensitivity status.
Region
Japan

Condition
Condition Prostate cancer with bone metastasis
Classification by specialty
Urology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To examine the efficacy of zoledronic acid in prostate cancer with bone metastasis at different hormone sensitivity status.
To examine bone marker (serum NTx) to assess judgment of the efficacy at early treatment and prognosis forecast.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Change of bone metastasis EOD grade
Key secondary outcomes Change of SRE and BPI

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-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 Hormon sensitive during zoledronic acid therapy
Interventions/Control_2 Hormon refractory after zoledronic acid therapy
Interventions/Control_3 Hormon refractory before zoledronic acid therapy
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 Patients of prostate cancer with bone metastasis
Key exclusion criteria 1.History of hypersensitivity for zoledronic acid or other bisphosphonate
2.Renal dysfunction(serum creatinine more than 3.0mg/dL)
3.Active concomititant malignancy
4.Severe coexisting disease
5.Invasive dental treatment within 3 months
6.Other bisphosphonate therapy for injection within 6 months
7.Not suitable for this trial
Target sample size 200

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Eiji Higashihara
Organization Kyorin University
Division name Department of urology
Zip code
Address 6-20-2 Shinkawa,Mitaka-city, Tokyo
TEL 0422-47-5511
Email

Public contact
Name of contact person
1st name
Middle name
Last name Takatsugu Okegawa
Organization Kyorin University
Division name Department of urology
Zip code
Address 6-20-2 Shinkawa,Mitaka-city,Tokyo
TEL 0422-47-5511
Homepage URL
Email

Sponsor
Institute Tama Prostate cancer Bone metastasis Study group
Institute
Department

Funding Source
Organization None
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 杏林大学医学部付属病院(東京都)、青梅市立病院(東京都)、河北総合病院(東京都)、公立阿伎留医療センター(東京都)、国立病院機構災害医療センター(東京都)、佐々総合病院(東京都)、多摩北部医療センター(東京都)、東京医科大学八王子医療センター(東京都)、都立府中病院(東京都)、西東京中央総合病院(東京都)、一橋病院(東京都)

Other administrative information
Date of disclosure of the study information
2009 Year 11 Month 26 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
2007 Year 04 Month 18 Day
Date of IRB
Anticipated trial start date
2007 Year 04 Month 01 Day
Last follow-up date
2016 Year 04 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2009 Year 11 Month 23 Day
Last modified on
2009 Year 11 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003365

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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