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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000012967
Receipt No. R000015153
Scientific Title Randomized control study to evaluate the efficacy of Denosumab versus zoledronic acid for treatment of bone metastases in men with prostate cancer
Date of disclosure of the study information 2014/01/31
Last modified on 2021/03/05

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Basic information
Public title Randomized control study to evaluate the efficacy of Denosumab versus zoledronic acid for treatment of bone metastases in men with prostate cancer
Acronym Randomized control study to evaluate the efficacy of Denosumab versus zoledronic acid for treatment of bone metastases in men with prostate cancer
Scientific Title Randomized control study to evaluate the efficacy of Denosumab versus zoledronic acid for treatment of bone metastases in men with prostate cancer
Scientific Title:Acronym Randomized control study to evaluate the efficacy of Denosumab versus zoledronic acid for treatment of bone metastases in men with prostate cancer
Region
Japan

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

Objectives
Narrative objectives1 To evaluate the efficacy and safety of Denosumab versus zoledronic acid for treatment of bone metastases in men with prostate cancer
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Biochemical markers of bone turnover(serum NTx,BAP)
Key secondary outcomes Serum PSA
Serum Ca
Skeltal related events
Progression-free survival
Over all survival
Adverse events
QOL

Base
Study type

Study design
Basic design Parallel
Randomization Randomized
Randomization unit
Blinding Open -no one is blinded
Control Active
Stratification NO
Dynamic allocation
Institution consideration
Blocking NO
Concealment Numbered container method

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Patients receive 120 mg denosumab every 4 week, and Combined Androgen Blockade (CAB) with LH-RH analog or surgical castration, and anti-androgen.
Interventions/Control_2 Patients receive 4 mg zoledronic acid every 4 week, and Combined Androgen Blockade (CAB) with LH-RH analog or surgical castration, and anti-androgen.
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
80 years-old >
Gender Male
Key inclusion criteria 1.Performance status 0-2 (ECOG)
2.Written informed consent
3.Histologically confirmed prostate cancer, existing radiographic evidence of at least one bone metastasis
4.Patients who satisfy the following
(a)WBC>=3000/mm3
(b)AST<=100 IU/L ,ALT<=100 IU/L, Serum creatinine<=2.0 mg/dl, Serum adjusted calcium8.0-10.0mg/dl
Key exclusion criteria 1.Patients who had prior bisphosphonate
2.Patients who are on hemodialysis
3.Patients who are treated with chemotherapy
4.Patients with poorly controlled hepatic disorder or renal dysfunction or diabetes
5.Patients who are receiving or planning treatment of tooth extraction or dental implant for oral infeciton
6.Patients who considered inappropriate for this trial by physicians
Target sample size 80

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Atsushi Komaru
Organization Chiba Cancer Center
Division name Urology
Zip code
Address 666-2 Nitona,Chuo-ku,Chiba,260-8717,Japan
TEL 043-264-5431
Email akomaru@chiba-cc.jp

Public contact
Name of contact person
1st name
Middle name
Last name Atsushi Komaru
Organization Chiba Cancer Center
Division name Urology
Zip code
Address 666-2 Nitona,Chuo-ku,Chiba,260-8717,Japan
TEL 043-264-5431
Homepage URL
Email akomaru@chiba-cc.jp

Sponsor
Institute Chiba Cancer Center
Institute
Department

Funding Source
Organization None
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
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 千葉県がんセンター(千葉県)

Other administrative information
Date of disclosure of the study information
2014 Year 01 Month 31 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 Terminated
Date of protocol fixation
2012 Year 09 Month 24 Day
Date of IRB
2012 Year 09 Month 19 Day
Anticipated trial start date
2013 Year 01 Month 23 Day
Last follow-up date
2015 Year 09 Month 24 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2014 Year 01 Month 26 Day
Last modified on
2021 Year 03 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015153

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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