UMIN-CTR Clinical Trial

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