Unique ID issued by UMIN | UMIN000015300 |
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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 |
Study of effectiveness of the switch from Gn-RH agonist to degarelix for patients with prostate cancer as a second-line hormone therapy
FELIX
Switch from Gn-RH agonist to degarelix on CRPC
Study of effectiveness of the switch from Gn-RH agonist to degarelix for patients with prostate cancer as a second-line hormone therapy
FELIX
Switch from Gn-RH agonist to degarelix on CRPC
Japan |
Prostate cancer
Urology | Adult |
Malignancy
NO
To see the effectiveness and safety of the switch from Gn-RH agonist to degarelix for patients of castration resistant prostate cancer.
Safety,Efficacy
Exploratory
PSA Responder rate at 12w
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
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
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.
20 | years-old | <= |
Not applicable |
Male
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
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
100
1st name | |
Middle name | |
Last name | Hiroji Uemura |
Yokohama City University medical center
Department of urology
4-57 Urafunecho, Minami-ku, Yokohama City, 232-0024, Japan
045-261-5656
hu0428@med.yokohama-cu.ac.jp
1st name | |
Middle name | |
Last name | Narihiko Hayashi |
Yokohama City University
Department of urology
3-9 Fukuura, Kanazawa-ku, Yokohama City, 236-0004, Japan
045-787-2800
twnary@yahoo.co.jp
Yokohama City University Hospital
Astellas Pharma Inc.
Profit organization
Japan
NO
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)
2014 | Year | 10 | Month | 01 | Day |
Partially published
Completed
2014 | Year | 07 | Month | 03 | Day |
2014 | Year | 10 | Month | 01 | Day |
2014 | Year | 10 | Month | 01 | Day |
2018 | Year | 08 | Month | 12 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017801
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