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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000018478
Receipt No. R000021396
Scientific Title Impact of endocrine therapy on lipid metabolism and bone metabolism of prostate cancer patients -Comparison with chlormadinone acetate and bicalutamide-
Date of disclosure of the study information 2015/08/10
Last modified on 2019/03/12

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Basic information
Public title Impact of endocrine therapy on lipid metabolism and bone metabolism of prostate cancer patients
-Comparison with chlormadinone acetate and bicalutamide-
Acronym Impact of endocrine therapy on lipid metabolism and bone metabolism of prostate cancer patients
Scientific Title Impact of endocrine therapy on lipid metabolism and bone metabolism of prostate cancer patients
-Comparison with chlormadinone acetate and bicalutamide-
Scientific Title:Acronym Impact of endocrine therapy on lipid metabolism and bone metabolism of prostate cancer patients
Region
Japan

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

Objectives
Narrative objectives1 Compare investigate the effect of chlormadinone acetate · GnRH agonist combination therapy or bicalutamide · GnRH agonist combination therapy for prostate cancer men on lipid metabolism and bone metabolism
Basic objectives2 Pharmacokinetics
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Comparison between treatment groups of lipid metabolism marker rate of change in two years from endocrine therapy start
Key secondary outcomes - Changes of bone density
- Bone metabolism marker rate of change
- Change of Aortocalcification index
- Changes of taste and preferences
- Changes of the quality of life
- progression-free survival
- Adverse event

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 GnRH agonists (12-13 weeks each)and
Chlormadinone acetate 50mg (Twice daily)
Interventions/Control_2 GnRH agonists (12-13 weeks each)and
Bicalutamide 80mg (Once a day)
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 1. Histologically who prostate (adenocarcinoma) have been identified (in all stages, EOD score 2 or less).
2. Who it is deemed necessary endocrine therapy for prostate cancer.
3. voluntary written informed consent
4. Age at the time of consent acquired more than 20 years of age
5. ECOG Performance Status 0-1
6. Organ function is maintained with the latest test values within registration before 4 weeks
-WBC>=3000/mm3
-PLT>=100,000/mm3
-Hemoglobin>=9.0g/dl
-ALT <= 2.5 x upper limit of normal
-AST <= 2.5 x upper limit of normal
- total bilirubin <= 1.5mg/dl
-creatinine <= 1.5mg/dl
7. Patients who are expected to survive more than 12 months
8. Initiation of therapy capable person within 4-8 weeks after registration.
Key exclusion criteria 1. Those who have received those who had received endocrine therapy current or against prostate cancer in the past.
2. A person who has received chemotherapy in the past.
3. A person who has been treated with estrogen agent in the past.
4. Those who received radiation therapy to the primary tumor or metastases within the past 3 months.
5. Of a person merger or suspicion of clinically important liver disease or symptomatic of hepatobiliary disease.
6. Those who have developed ischemic heart disease within 6 months
7. A person having control difficult complications (heart disease, severe diabetes, bleeding, etc.).
8. Administration contraindication:
CMA, Bicalutamide, goserelin acetate, acetic acid leuprorelin
9. Those of active double cancer.
10. There is a thrombotic predisposition, or person who has a thrombosis.
11. Registration within 28 days prior person who has used other investigational drugs and clinical trials for medical equipment and post-marketing clinical study drug.
12. Person who is pregnant or lactating
Person judged as unsuitable for the study by the investigator
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hideki Sakai
Organization Nagasaki University Hospital
Division name Department of Nephro-Urology
Zip code
Address 1-7-1 Sakamoto,Nagasaki
TEL 095-19-7340
Email hsakai@nagasaki-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Tomoaki Hakariya
Organization Nagasaki University Hospital
Division name Department of Nephro-Urology
Zip code
Address 1-7-1 Sakamoto,Nagasaki
TEL 095-19-7340
Homepage URL
Email erbb2jp@yahoo.co.jp

Sponsor
Institute Nagasaki University Hospital
Institute
Department

Funding Source
Organization The Japanese Fundation for Prostate Research.
Organization
Division
Category of Funding Organization Non profit foundation
Nationality of Funding Organization

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
2015 Year 08 Month 10 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 No longer recruiting
Date of protocol fixation
2015 Year 03 Month 22 Day
Date of IRB
2015 Year 02 Month 24 Day
Anticipated trial start date
2015 Year 09 Month 01 Day
Last follow-up date
2020 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2015 Year 07 Month 29 Day
Last modified on
2019 Year 03 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021396

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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