UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Study of effectiveness of the switch from Gn-RH agonist to degarelix for patients with prostate cancer as a second-line hormone therapy
Title of the study (Brief title)	FELIX Switch from Gn-RH agonist to degarelix on CRPC
Region	Japan

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

Objectives
Narrative objectives1	To see the effectiveness and safety of the switch from Gn-RH agonist to degarelix for patients of castration resistant prostate cancer.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	PSA Responder rate at 12w
Key secondary outcomes	1)Time to PSA increase by 25 % compared to PSA st starting this study in Responder 2)Time to PSA progression survival 3)Time to treatoment fairule 4)Time to overall survival 5)Time to cancer specific survival 6)Time to radiographic PFS 7)safty

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	Switch from Gn-RH agonistto degarelix. Degarelix is adoministred to the patients for 12 months. First time,degarelix(240mg/body)will be administered subcutaneously. After 4 weeks,degarelix(80mg/body)will be administered subcutaneously every 4 weeks.
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	20 years-old <=
Age-upper limit	Not applicable
Gender	Male
Key inclusion criteria	1)Patient with histologically confirmed prostate cancer 2)Patient whose PSA level are rising more than 2 ng/ml consecutively twice 3)Testosterone levels which are measured within 28 days before the entry of this study are less than 50 ng/dl 4)Patients without AWS 5)Patients aged 20 or above 6)ECOG performance states 0-1 7)Laboratory requirements WBC is equal to or higher than 3000/mm3 Hb is equal to or higher than 10.0 g/dl PLT is equal to or higher than 100000/mm3 Serum Creatinine is equal to or less than 2.0mg/dl AST is equal to or less than 100U/l ALT is equal to or less than 100U/l 8)Patients who provide the documents of agreement for this study
Key exclusion criteria	Patients 1)who have a treatment history of degarelix 2)who have a treatment history of Enzalutamide or Abraterone 3)who are using steroid 4)who are using estrogen 5)who are using 5-alpha-reductase inhibitor 6)who have a serious cardiovascular disease 7)who have in active cancer except prostate cancer 8)have an allergy to degarelix 9)who are disqualified by a doctor in charge
Target sample size	100

Research contact person
Name of lead principal investigator	Hiroji Uemura
Organization	Yokohama City University medical center
Division name	Department of urology
Address	4-57 Urafunecho, Minami-ku, Yokohama City, 232-0024, Japan
TEL	045-261-5656
Email	hu0428@med.yokohama-cu.ac.jp

Public contact
Name of contact person	Narihiko Hayashi
Organization	Yokohama City University
Division name	Department of urology
Address	3-9 Fukuura, Kanazawa-ku, Yokohama City, 236-0004, Japan
TEL	045-787-2800
Homepage URL
Email	twnary@yahoo.co.jp

Sponsor
Institute	Yokohama City University Hospital
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)

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	横浜市立大学附属病院（神奈川県） 横浜市立大学附属市民総合医療センター（神奈川県） 横須賀共済病院（神奈川県） 藤沢市民病院（神奈川県） 横浜みなと赤十字病院（神奈川県） 横浜南共済病院（神奈川県） 川崎市立井田病院（神奈川県） 神奈川県立がんセンター（神奈川県） 国際親善総合病院（神奈川県） 大和市立病院（神奈川県） 横浜市立市民病院（神奈川県） 大口東総合病院（神奈川県） 小田原市立病院（神奈川県） 国立病院機相模原病院（神奈川県） 横浜栄共済病院（神奈川県） 藤沢湘南台病院（神奈川県） 茅ヶ崎市立病院（神奈川県） 東芝林間病院（神奈川県） 秦野赤十字病院（神奈川県） 神奈川リハビリテーション病院（神奈川県） 平塚共済病院（神奈川県） 済生会横浜市南部病院（神奈川県） 横浜保土ヶ谷中央病院（神奈川県） 衣笠病院（神奈川県） 神奈川県立足柄上病院（神奈川県）

Other administrative information
Date of disclosure of the study information	2014 Year 10 Month 01 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 07 Month 03 Day
Anticipated trial start date	2014 Year 10 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Partially published
URL releasing results
Results
Other related information

Management information
Registered date	2014 Year 10 Month 01 Day
Last modified on	2018 Year 08 Month 12 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017801