UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018478 |
|---|---|
| Receipt number | 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 | 2021/10/22 11:45:58 |
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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
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
erbb2jp@yahoo.co.jp
Sponsor or person
Institute
Nagasaki University Hospital
Institute
Department
Personal name
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
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
Completed
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
| 2021 | Year | 10 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021396
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