UMIN-CTR Clinical Trial

Basic information
Public title	Change of bone quality during endocrine therapy for prostate cancer
Acronym	Change of bone quality during endocrine therapy for prostate cancer
Scientific Title	Change of bone quality during endocrine therapy for prostate cancer
Scientific Title:Acronym	Change of bone quality during endocrine therapy for prostate cancer
Region	Japan

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

Objectives
Narrative objectives1	Androgen deprivation therapy is effective treatment for metastatic and advanced prostate cancer. Osteoporosis is one of the most severe adverse events of this treatment. Recently, not only bone mineral density but also bone quality has been reported to be important factor for osteoporosis. However, influence of androgen deprivation therapy on bone quality has not been elucidated. In this study, change of bone quality during endocrine therapy for prostate cancer will be observed.
Basic objectives2	Others
Basic objectives -Others	Primary endpoint: Change of bone quality markers Secondary endpoint: Change of BMD, incidence of fracture, QOL
Trial characteristics_1	Exploratory
Trial characteristics_2	Others
Developmental phase	Not applicable

Assessment
Primary outcomes	Change of bone quality markers
Key secondary outcomes	Change of BMD, incidence of fracture, QOL

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
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Purpose of intervention
Type of intervention
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Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	85 years-old >=
Gender	Male
Key inclusion criteria	1) Pathologically diagnosed prostate cancer 2) Planned androgen deprivation therapy for more than 1 year as initial therapy.
Key exclusion criteria	1) Prior history of androgen deprivation therapy 2) Prior history of steroidal therapy
Target sample size	80

Research contact person
Last name of lead principal investigator	1st name Middle name Last name Shin Egawa
Organization	Jikei University School of Medicine
Division name	Department of Urology
Zip code
Address	3-25-8, Nishi shinbashi, Minato-ku, Tokyo
TEL	0334331111
Email	s-egpro@jikei.ac.jp

Public contact
1st name of contact person	1st name Middle name Last name Takahiro Kimrua
Organization	Jikei University School of Medicine
Division name	Department of Urology
Zip code
Address	3-25-8, Nishi shinbashi, Minato-ku, Tokyo
TEL	0334331111
Homepage URL
Email	tkimura@jikei.ac.jp

Sponsor
Institute	Department of Urology, Jikei University School of Medicine
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
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IRB Contact (For public release)
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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	東京慈恵会医科大学附属病院（東京都）

Other administrative information
Date of disclosure of the study information	2017 Year 01 Month 01 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
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Results Delayed
Results Delay Reason
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Baseline Characteristics
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IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 10 Month 10 Day
Date of IRB	2015 Year 10 Month 10 Day
Anticipated trial start date	2016 Year 02 Month 17 Day
Last follow-up date	2019 Year 11 Month 30 Day
Date of closure to data entry	2019 Year 11 Month 30 Day
Date trial data considered complete	2019 Year 11 Month 30 Day
Date analysis concluded	2019 Year 11 Month 30 Day

Other
Other related information	Subjects Patients with prostate cancer planned of androgen deprivation therapy from Jan 1st, 2016 to Dec 31, 2017. Observation 1) BMD 2) whole bone scintigram 3) X ray 4) bone quality markers 5) bone metabolic markers 6) QOL

Management information
Registered date	2015 Year 11 Month 16 Day
Last modified on	2019 Year 05 Month 20 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000022873