UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000015300
Receipt number R000017801
Scientific Title Study of effectiveness of the switch from Gn-RH agonist to degarelix for patients with prostate cancer as a second-line hormone therapy
Date of disclosure of the study information 2014/10/01
Last modified on 2018/08/12 19:59:02

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Basic information

Public title

Study of effectiveness of the switch from Gn-RH agonist to degarelix for patients with prostate cancer as a second-line hormone therapy

Acronym

FELIX
Switch from Gn-RH agonist to degarelix on CRPC

Scientific Title

Study of effectiveness of the switch from Gn-RH agonist to degarelix for patients with prostate cancer as a second-line hormone therapy

Scientific Title:Acronym

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

1st name
Middle name
Last name Hiroji Uemura

Organization

Yokohama City University medical center

Division name

Department of urology

Zip code


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

1st name
Middle name
Last name Narihiko Hayashi

Organization

Yokohama City University

Division name

Department of urology

Zip code


Address

3-9 Fukuura, Kanazawa-ku, Yokohama City, 236-0004, Japan

TEL

045-787-2800

Homepage URL


Email

twnary@yahoo.co.jp


Sponsor or person

Institute

Yokohama City University Hospital

Institute

Department

Personal name



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


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

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


Related information

URL releasing protocol


Publication of results

Partially published


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

2014 Year 07 Month 03 Day

Date of IRB


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



Other

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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017801


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name