UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Endocrinological profiles in patients with prostate cancer treated with LHRH antagonist
Title of the study (Brief title)	Endocrinological profiles of LHRH antagonist
Region	Japan

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

Objectives
Narrative objectives1	This study is aimed to study the changes of endocrinological parameters in patients with prostate cancer treated with LHRH antagonist, Degarelix.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Changes of serum sex and peptide hormones.
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	LHRH antagonist, degarelix
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

Eligibility
Age-lower limit	Not applicable
Age-upper limit	Not applicable
Gender	Male
Key inclusion criteria	Patients with prostate cancer treated with LHRH antagonist, Degarelix
Key exclusion criteria	1. Patients treated with concomitant anti-androgens. 2. Patients treated with concomitant medicines that affect serum sex hormone levels.
Target sample size	50

Research contact person
Name of lead principal investigator	Kazuhiro Suzuki
Organization	Gunma University Graduate School of Medicine
Division name	Department of Urology
Address	3-39-22 Showa-machi, Maebashi, Gunma, Japan
TEL	027-220-8300
Email	kazu@gunma-u.ac.jp

Public contact
Name of contact person	Kazuhiro Suzuki
Organization	Gunma University Graduate School of Medicine
Division name	Department of Urology
Address	3-39-22 Showa-machi, Maebashi, Gunma, Japan
TEL	027-220-8300
Homepage URL
Email	kazu@gunma-u.ac.jp

Sponsor
Institute	Department of Urology, Gunma University Graduate School of Medicine
Institute
Department

Funding Source
Organization	Astellas Pharmaceutical. Co. Ltd
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

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

Other administrative information
Date of disclosure of the study information	2013 Year 10 Month 08 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2012 Year 12 Month 05 Day
Anticipated trial start date	2013 Year 12 Month 05 Day
Last follow-up date	2015 Year 04 Month 30 Day
Date of closure to data entry	2015 Year 07 Month 30 Day
Date trial data considered complete	2015 Year 08 Month 30 Day
Date analysis concluded	2015 Year 12 Month 30 Day

Related information
URL releasing protocol
Publication of results	Published
URL releasing results	https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5575925/
Results	Degarelix reduced serum testosterone levels soon after the first administration. It also reduced serum adrenal androgen levels.
Other related information

Management information
Registered date	2013 Year 10 Month 08 Day
Last modified on	2017 Year 10 Month 12 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000012049