UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005630 |
|---|---|
| Receipt number | R000006650 |
| Scientific Title | A clinical study of generic drug of bicalutamide on the efficacy and the safety in prostate cancer patients |
| Date of disclosure of the study information | 2011/05/23 |
| Last modified on | 2016/05/23 11:51:36 |
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Basic information
Public title
A clinical study of generic drug of bicalutamide on the efficacy and the safety in prostate cancer patients
Acronym
A clinical study of generic bicalutamide in prostate cancer (GB-study)
Scientific Title
A clinical study of generic drug of bicalutamide on the efficacy and the safety in prostate cancer patients
Scientific Title:Acronym
A clinical study of generic bicalutamide in prostate cancer (GB-study)
Region
| Japan |
Condition
Condition
Prostate cancer
Classification by specialty
| Urology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To study the efficacy and the safety of generic drug of bicalutamide in combination with LH-RH agonist in prostate cancer patients
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
PSA level
Normalization rate of PSA level
Key secondary outcomes
IPSS
Serum hormone
Prostate volume
Adverse event
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 45 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male
Key inclusion criteria
Pathologically confirmed prostate cancer patients who need the treatment with bicalutamide and LH-RH agonist.
1. over 45 years of age
2. PS is 0 to 2
3. Patient whom survival is expected over three months
4. Informed consent
Key exclusion criteria
1. AST (GOT), ALT (GPT), ALP: > 2.5 times of institution standard value.
2. Serum creatinine: > 1.5 times of institution standard value.
3. WBC: < 3,000/mm3
4. Hemoglobin: < 10 g/dl
5. Platelet: < 75,000/mm3
6. Patient with critical illness (liver cirrhosis, liver failure, chronic kidney failure, heart failure, myocardial infarction within 3 months, uncontrolled hypertension, uncontrolled diabetes, serious pulmonary fibrosis, active interstitial pneumonia, immunodeficiency, active double cancer, etc)
7. Patients participating in any clinical researches or clinical trials.
8. Patients who were judged inappropriate for the clinical research by the investigator.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yusaku Okada, M.D., Ph.D |
Organization
Shiga University of Medical Science
Division name
Department of Urology
Zip code
Address
Seta Tsukinowa-cho, Otsu 520-2192, JAPAN
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Biwako health and welfare consortium
Division name
Secretariat
Zip code
Address
TEL
Homepage URL
npobiwa@belle.shiga-med.ac.jp
Sponsor or person
Institute
Biwako health and welfare consortium
Institute
Department
Personal name
Funding Source
Organization
Biwako health and welfare consortium
Organization
Division
Category of Funding Organization
Non profit foundation
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
滋賀医科大学病院（滋賀県）、大津市民病院（滋賀県）、こうなみクリニック（滋賀県）、市立長浜病院（滋賀県）
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 05 | Month | 23 | Day |
Related information
URL releasing protocol
Publication of results
Published
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
| 2011 | Year | 01 | Month | 28 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2012 | Year | 08 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2013 | Year | 08 | Month | 01 | Day |
Other
Other related information
The primary endpoint "PSA Value Changes", the original drug and the formulation of Casodex bicalutamide combination therapy with LH-RH agonist and bicalutamide tablet data in 100 cases of prostate cancer patients received for the past five years group and the generic drug of bicalutamide combination with LH-RH agonist group, the comparative study.
Management information
Registered date
| 2011 | Year | 05 | Month | 23 | Day |
Last modified on
| 2016 | Year | 05 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006650
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
