UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007548 |
|---|---|
| Receipt number | 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 13:53:06 |
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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
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
Sponsor or person
Institute
Kinki University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008914
| Research Plan | |
|---|---|
| Registered date | File name |
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| Registered date | File name |
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