Unique ID issued by UMIN | UMIN000027795 |
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Receipt number | R000029208 |
Scientific Title | The phaseII study of the efficacy of Abirateron acetate and Dutasteride therapy for castration resistant prostate cancer. |
Date of disclosure of the study information | 2017/07/01 |
Last modified on | 2017/06/17 11:27:56 |
The phaseII study of the efficacy of Abirateron acetate and Dutasteride therapy for castration resistant prostate cancer.
The efficacy of Abirateron and Dutasteride for CRPC.
The phaseII study of the efficacy of Abirateron acetate and Dutasteride therapy for castration resistant prostate cancer.
The efficacy of Abirateron and Dutasteride for CRPC.
Japan |
castration resistant prostate cancer
Urology |
Malignancy
YES
The purpose of this study is to evaluate the effect and safety of androgen synthesis inhibition with abiraterone and dutasteride for the patients with castration resistant prostate cancer and benign prostate hyperplasia before the therapy of Docetaxel.
Efficacy
the rate of patients with over fifty percent reduction in PSA
Time-to-treatment failure
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
Patients is treated with abiraterone (1,000 mg daily) and prednisone (5 mg daily) for two 4-week cycles. After this time, dutasteride (0.5 mg daily) is added for 12 weeks. Patients continue on the three-drug regimen until study withdrawal or radiographic disease progression.
50 | years-old | <= |
90 | years-old | > |
Male
1)advanced prostate cancer (>stage III) with androgen deprivation therapy
2)a serum total testosterone <50 ng/dL
3)PSA progression as defined by the Prostate Cancer Clinical Trials Working Group
4)patients with benign prostate hyperplasia (IPSS>9)
5)
Hematologic and laboratory criteria including
White blood cell >3,000/mm3
Hemoglobin>8.0 g/dL
Platelet count>100000/mm3
aspartate aminotransferase (AST) <100 IU/L
alanine aminotransferase (ALT) <100 IU/L
Serum creatinine <1.5 mg/dL
patients provide written informed consent
1)Patients took 5alpha-reductase inhibitors previously
2)AST >101 IU/L or ALT>101 IU/L or Child-Pugh score C
3)HbA1c > 10%
4)serum potassium < 3.5 mEq/l
20
1st name | |
Middle name | |
Last name | Hideyasu Matsuyama |
Yamaguchi Graduate School of Medicine
Urology
1-1-1, Minamikogushi, Ube, Yamaguchi, Japan
0836-22-2275
hidde@yamaguchi-u.ac.jp
1st name | |
Middle name | |
Last name | Yoshihisa Kawai |
Yamaguchi Graduate School of Medicine
Urology
1-1-1, Minamikogushi, Ube, Yamaguchi, Japan
0836-22-2275
yoshipisa23@yahoo.co.jp
Department od Urology, Yamaguchi Graduate School of Medicine
Grant-in-Aid for Scientific Research
Non profit foundation
NO
2017 | Year | 07 | Month | 01 | Day |
Unpublished
Preinitiation
2017 | Year | 04 | Month | 27 | Day |
2017 | Year | 08 | Month | 01 | Day |
2017 | Year | 06 | Month | 17 | Day |
2017 | Year | 06 | Month | 17 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029208
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