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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000007548
Receipt No. R000008914
Scientific Title Phase II study of zoledronic acid concomitant with androgen deprivation therapy for patients with treatment-naive bone-metastatic prostate cancer
Date of disclosure of the study information 2012/03/21
Last modified on 2013/03/06

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Basic information
Public title Phase II study of zoledronic acid concomitant with androgen deprivation therapy for patients with treatment-naive bone-metastatic prostate cancer
Acronym Zoledronic acid with ADT for treatment-naive bone-metastatic prostate cancer
Scientific Title Phase II study of zoledronic acid concomitant with androgen deprivation therapy for patients with treatment-naive bone-metastatic prostate cancer
Scientific Title:Acronym Zoledronic acid with ADT for treatment-naive bone-metastatic prostate cancer
Region
Japan

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

Objectives
Narrative objectives1 To examine the efficacy and safety of introduction of zoledronic acid at the beginning of androgen deprivation therapy for patients with treatment-naive bone-metastatic prostate cancer.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase Phase II

Assessment
Primary outcomes Skeleton-related event-free survival at 24 month after the introduction of treatment
Key secondary outcomes Progression-free survival, time to first SRE, overall survival, decrease of the extent of bone diseases, improvement of pain, and safety

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Bicalutamide (AstraZeneca, Tokyo, Japan) 80mg administered orally on Day 1 and every day, goserelin acetate (AstraZeneca, Tokyo, Japan) 10.8mg administered subcutaneously on Day 8 and every 12 weeks, and zoledronic acid (Novartis Pharma, Tokyo, Japan) 4mg administered intravenously on Day 8 and every 4 weeks. Zoledronic acid was continued as long as 24 months regardless of disease progression.
Interventions/Control_2
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

Not applicable
Gender Male
Key inclusion criteria Treatment-naive male patients with histologically confirmed adenocarcinoma of the prostate.
Radiologic evidence of bone metastasis.
Eastern Cooperative Oncology Group performance status of 0 or 1.
Adequate bone marrow, hepatic, and renal function:
White blood cell count >4.0x103/mm3
Platelet count >100x103/ mm3
Hemoglobin >10.0 g/dL
Serum bilirubin <1.5 times the upper limit of normal
Aspartate and alanine aminotransferase levels <2.5 times the ULN
Creatinine clearance >60mL/min
ECOG performance status of 2 due to bone disease was permitted.
Key exclusion criteria Symptomatic central nervous system metastases.
Coagulation disorders.
Infection requiring intravenous antibiotics.
Radiologically proved interstitial pneumonitis.
Clinically significant cardiovascular disease.
Pleural or pericardial effusion
Dental problem requiring invasive treatment.
History of bisphosphonate.
History of another malignancy within the preceding 5 years.
Target sample size 52

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hirotsugu Uemura
Organization Kinki University
Division name Department of Urology
Zip code
Address 377-2 Ohno-higashi, Osaka-sayama
TEL 072-366-0221
Email

Public contact
Name of contact person
1st name
Middle name
Last name Masahiro Nozawa
Organization Kinki University
Division name Department of Urology
Zip code
Address 377-2 Ohno-higashi, Osaka-sayama
TEL 072-366-0221
Homepage URL
Email

Sponsor
Institute Kinki University
Institute
Department

Funding Source
Organization Kinki University
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

Other administrative information
Date of disclosure of the study information
2012 Year 03 Month 21 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 Completed
Date of protocol fixation
2008 Year 03 Month 01 Day
Date of IRB
Anticipated trial start date
2008 Year 07 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2012 Year 03 Month 21 Day
Last modified on
2013 Year 03 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008914

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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