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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000002577
Receipt No. R000003142
Scientific Title Effect of Zoledronic acid for Stage D2 hormone-sensitive prostate cancer patients.
Date of disclosure of the study information 2009/10/05
Last modified on 2009/10/02

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Basic information
Public title Effect of Zoledronic acid for Stage D2 hormone-sensitive prostate cancer patients.
Acronym Effect of Zoledronic acid for Stage D2 hormone-sensitive prostate cancer patients.
Scientific Title Effect of Zoledronic acid for Stage D2 hormone-sensitive prostate cancer patients.
Scientific Title:Acronym Effect of Zoledronic acid for Stage D2 hormone-sensitive prostate cancer patients.
Region
Japan

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

Objectives
Narrative objectives1 To evaluate of efficacy of MAB therapy with Zoledronic acid for newly diagnosed Stage D2 prostate cancer patients.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Phase II

Assessment
Primary outcomes 1 PSA nadir rate
2 Time to PSA nadir
Key secondary outcomes 1 Refractory Free Survival
2 Safety

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification YES
Dynamic allocation YES
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment No need to know

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 MAB (combination of LHRH agonist and non-steroidal antiandrogen) therapy until PSA refractory
Interventions/Control_2 MAB therapy with 4mg Zoledronic acid at every 4 weeks
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

Not applicable
Age-upper limit
85 years-old >=
Gender Male
Key inclusion criteria 1. Untreated prostate cancer patients with bone metastasis
2. Age is 85 years old or less.
3. Keeping liver and kidney function and filled following criteria;
* WBC: >= 3000 / mm3
* PLT: >= 10,000 / mm3
* Ht: <= normal range
* AST(GOT): <= 2.5 times high end of the normal range
* ALT(GPT): <= 2.5 times high end of the normal range
* GGT: <= 2.5 times high end of the normal range
* ALP: <= 2.5 times high end of the normal range
* LDH: <= 1.5 times high end of the normal range
* sCr: <= 3.0 times high end of the normal range
* Performance Status(ECOG) 0,1 (including seeming PS 2-4 by only bone metastasis)
* agreement of participation from patients by document with sufficient explanation
Key exclusion criteria 1.CCr < 30mL/min by calculation of Codkcroft Gault equation.
2. Another cancer that requires treatment
3. Patients coexisting psychiatric disease or neurological symptom
4. Patients with continuous systematic treatment with steroids
5. Participation in the present study is considered inappropriate by a Clinical Investigator
Target sample size 96

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Mototsugu Oya
Organization Keio University School of Medicine
Division name Department of Urology
Zip code
Address 35 Shinano-machi, Shinjuku-ku, Tokyo, 160-8582, Japan
TEL 03-5363-3825
Email

Public contact
Name of contact person
1st name
Middle name
Last name Ken Nakagawa
Organization Keio University School of Medicine
Division name Department of Urology
Zip code
Address 35 Shinano-machi, Shinjuku-ku, Tokyo, 160-8582, Japan
TEL 03-5363-3825
Homepage URL
Email mizunor@z7.keio.jp

Sponsor
Institute Department of Urology, Keio University School of Medicine
Institute
Department

Funding Source
Organization non
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization Japan

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
2009 Year 10 Month 05 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 Preinitiation
Date of protocol fixation
2009 Year 10 Month 01 Day
Date of IRB
Anticipated trial start date
2009 Year 12 Month 01 Day
Last follow-up date
2013 Year 12 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 10 Month 02 Day
Last modified on
2009 Year 10 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003142

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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