UMIN-CTR Clinical Trial

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/icdr_e/ctr_view.cgi?recptno=R000015153