UMIN-CTR Clinical Trial

Basic information
Public title	Randomized controlled study of GnRH antagonist monotherapy and CAB with GnRH agonist plus bicalutamide for patients with metastatic prostate cancer.
Acronym	Randomized controlled study of GnRH antagonist monotherapy and CAB with GnRH agonist plus bicalutamide for patients with metastatic prostate cancer.(KYUCOG-1401)
Scientific Title	Randomized controlled study of GnRH antagonist monotherapy and CAB with GnRH agonist plus bicalutamide for patients with metastatic prostate cancer.
Scientific Title:Acronym	Randomized controlled study of GnRH antagonist monotherapy and CAB with GnRH agonist plus bicalutamide for patients with metastatic prostate cancer.(KYUCOG-1401)
Region	Japan

Condition
Condition	metastatic prostate cancer
Classification by specialty	Urology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To investigate a clinical response of the GnRH agonist CAB therapy against GnRH antagonist monotherapy for metastatic prostate cancer.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase	Phase III

Assessment
Primary outcomes	PSA Progression Free Survival
Key secondary outcomes	1. Time to CAB Treatment Failure (TTF in the case of deferred CAB therapy in antagonist monotherapy group) 2. Overall Survival 3. Progression Free Survival in image diagnosis 4. Radiographic Progression Free Survival 5. Change of PSA 6. Effect on hormone dynamics 7. Change of bone metabolic markers 8. Effect on lipid metabolism 9. Adverse event

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification	YES
Dynamic allocation	YES
Institution consideration	Institution is not considered as adjustment factor.
Blocking
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Degarelix 240mg, sc at day 1. Degarelix 240mg, sc every 4 weeks. Bicalutamide 80mg daily(as deferred CAB therapy in the case of PSA recurrence)
Interventions/Control_2	Leuprorelin or goserelin: subcutaneous injection (according to usage and administration of package insert). Bicalutamide 80mg daily.
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. Histopathological confirmed prostate cancer patients. 2. Patients with metastatic prostate cancer (Stage D1,D2). 3. Patients' survival is expected more than six months. 4. Patients with written informed consent.
Key exclusion criteria	1. Patients with history of treatment or under treatment on prostate cancer. 2. Patients with active double cancer. Patients with history of malignant tumor within the past 5 years are regarded as having active double cancer. The basal cell carcinoma that radical treatment was taken or superficial squamous cell carcinoma are not included in active double cancer.) 3. Patients with less than 20 years of age on the enrollment day. 4. Any other patients who are regarded as unsuitable for this study by the investigators.
Target sample size	200

Research contact person
Name of lead principal investigator	1st name Seiji Middle name Last name Naito
Organization	HARASANSHIN Hospital
Division name	Urology
Zip code	8120033
Address	1-8 Taihakumachi ,Hakata-ku,Fukuoka, Japan 812-0033
TEL	092-291-3434
Email	naito@harasanshin.or.jp

Public contact
Name of contact person	1st name Akira Middle name Last name Yokomizo
Organization	HARASANSHIN Hospital
Division name	Urology
Zip code	8120033
Address	1-8 Taihakumachi ,Hakata-ku,Fukuoka, Japan 812-0033
TEL	092-291-3434
Homepage URL
Email	yokoa@harasanshin.or.jp

Sponsor
Institute	Clinical Research Support Center Kyushu
Institute
Department

Funding Source
Organization	Astellas Pharma Inc.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Clinical Research Network Fukuoka Certified Review Board
Address	3-1-1 Maidashi, Higashi-ku, Fukuoka.
Tel	092-643-7171
Email	mail@crnfukuoka.jp

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	九州大学病院（福岡県）　 長崎大学病院（長崎県） 山口大学病院（山口県） 宮崎大学病院（宮崎県） 鹿児島大学病院（鹿児島県） 他大学関連施設

Other administrative information
Date of disclosure of the study information	2014 Year 06 Month 12 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	200
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	2014 Year 06 Month 03 Day
Date of IRB	2014 Year 06 Month 13 Day
Anticipated trial start date	2014 Year 07 Month 01 Day
Last follow-up date	2020 Year 06 Month 30 Day
Date of closure to data entry
Date trial data considered complete	2020 Year 10 Month 31 Day
Date analysis concluded	2020 Year 12 Month 31 Day

Other
Other related information

Management information
Registered date	2014 Year 06 Month 12 Day
Last modified on	2020 Year 12 Month 15 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016585