UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A clinical study of generic drug of bicalutamide on the efficacy and the safety in prostate cancer patients
Title of the study (Brief title)	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

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

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	Yusaku Okada, M.D., Ph.D
Organization	Shiga University of Medical Science
Division name	Department of Urology
Address	Seta Tsukinowa-cho, Otsu 520-2192, JAPAN
TEL
Email

Public contact
Name of contact person
Organization	Biwako health and welfare consortium
Division name	Secretariat
Address
TEL
Homepage URL
Email	npobiwa@belle.shiga-med.ac.jp

Sponsor
Institute	Biwako health and welfare consortium
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2011 Year 01 Month 28 Day
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

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006650