Unique ID issued by UMIN | UMIN000007771 |
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Receipt number | R000008981 |
Scientific Title | Clinical study to evaluate the efficacy and safety of LH-RH agonist alternative therapy on prostate cancer patients who relapsed after combined androgen blockade. |
Date of disclosure of the study information | 2012/10/01 |
Last modified on | 2012/04/16 16:37:09 |
Clinical study to evaluate the efficacy and safety of LH-RH agonist alternative therapy on prostate cancer patients who relapsed after combined androgen blockade.
Clinical study to evaluate the efficacy and safety of LH-RH agonist alternative therapy on prostate cancer patients who relapsed after combined androgen blockade.
Clinical study to evaluate the efficacy and safety of LH-RH agonist alternative therapy on prostate cancer patients who relapsed after combined androgen blockade.
Clinical study to evaluate the efficacy and safety of LH-RH agonist alternative therapy on prostate cancer patients who relapsed after combined androgen blockade.
Japan |
Prostate cancer
Urology |
Malignancy
NO
To evaluate the efficacy and safety of LH-RH agonist alternative therapy on prostate cancer patients who were receiving combined androgen blockade (CAB) but had progression.
Safety,Efficacy
Exploratory
Pragmatic
Phase II
PSA response and response duration
Time to treatment failure (TTTF)
Adverse events
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
LHRH agonistwill be changed to another LHRH agonist.
20 | years-old | <= |
79 | years-old | >= |
Male
1)Pathologically proven prostate cancer
2)Performance status 0-2(ECOG)
3)Age<80 years old
4)Patients who satisfy the following
a)WBC>3.0x10000/uL
b)hemoglobin>10.0g/dL
c)platelet>10x100000/uL
d)serum creatinine<2.0mg/dL
e)AST<100U/L
f)ALT<100U/L
5)Written informed consent can be obtained
1)Patients who have not observed anti-androgen withdrawal syndrome(AWS)
2)Treated with steroid drug
3)Undergone bilateral orchidectomy
4)Treated with chemotherapy
5)Treated with anti-androgen for benign prostate hyperplasia(BPH)
6)Considered inappropriate for this study by physicians
60
1st name | |
Middle name | |
Last name | Mikinobu Ohtani |
Ibaraki Prefectural Central Hospital
Department of Urology
6528 Koibuchi, Kasama-City, Ibaraki
1st name | |
Middle name | |
Last name | Mikinobu Ohtani |
Ibaraki Prefectural Central Hospital
Department of Urology
6528 Koibuchi, Kasama-City, Ibaraki
Department of Urology, Ibaraki Prefecture Central Hospital
None
Self funding
None
None
NO
2012 | Year | 10 | Month | 01 | Day |
Unpublished
Open public recruiting
2012 | Year | 02 | Month | 24 | Day |
2012 | Year | 05 | Month | 01 | Day |
2014 | Year | 05 | Month | 01 | Day |
2015 | Year | 05 | Month | 01 | Day |
2015 | Year | 06 | Month | 01 | Day |
2015 | Year | 07 | Month | 01 | Day |
2012 | Year | 04 | Month | 16 | Day |
2012 | Year | 04 | Month | 16 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008981
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