UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002577 |
|---|---|
| Receipt number | 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 18:52:59 |
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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
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
mizunor@z7.keio.jp
Sponsor or person
Institute
Department of Urology, Keio University School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003142
