Unique ID issued by UMIN | UMIN000004406 |
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Receipt number | R000005261 |
Scientific Title | Low dose estramustine phosphate against castration-resistant prostate cancer: phase II study |
Date of disclosure of the study information | 2010/10/18 |
Last modified on | 2016/08/28 17:37:40 |
Low dose estramustine phosphate against castration-resistant prostate cancer: phase II study
Low dose EMP against CRPC
Low dose estramustine phosphate against castration-resistant prostate cancer: phase II study
Low dose EMP against CRPC
Japan |
Castration-resistant prostate cancer
Urology |
Malignancy
NO
Effectiveness and adverse effects of low dose estramustine phosphate against castration-resistant prostate cancer will be evaluated. Cases were dichotomized between those with and without previous docetaxel chemotherapy at the time of the entry.
Safety,Efficacy
Confirmatory
Phase II
PSA response rate
Interventional
Single arm
Non-randomized
Open -no one is blinded
Historical
1
Treatment
Medicine |
Oral intake of low dose estramustine phosphate (313.4mg or 156.7mg)
20 | years-old | <= |
85 | years-old | > |
Male
1) Evidence of progressive disease during androgen deprivation therapy (LHRH analog with or without antiandrogen)(including a trial of anti-androgen withdrawal therapy) according to PCWG1 criteria for phase II trial
2) More than 6 weeks have passed after final antiandrogen therapy (this is not the case with patients who have received antiandrogen therapy less than 6 months)
3) PSA values should be more than 2ng/ml within 4 weeks before enrollment (The most recent data is employed)
4) All patients can be enrolled with or without previous docetaxel treatment
5) At least 4 weeks should be passed after surgery or radiation
6) Patients must have normal organ and marrow functions as defined below:
Absolute white blood cell count greater than or equal to 3000/mcL
Hemoglobin greater than or equal to 9g/dl
Platelets greater than or to 75000/mcL
AST less than or equal to 90IU/L
ALT less than or equal to 100IU/L
Creatinine less than or equal to 2.0mg/dl
7) ECOG performance status 0-2
8) Age greater than or equal to 20 years and less than 85 years at the time of enrollment
9) Patient must be able to understand and willing to sign a written informed consent document.
1) Patients who have had estramustine phosphate therapy (including other estrogen-based hormone therapy)
2) Patients with malignancy within 5 years except carcinoma in situ or other malignancies limited within visceral mucosa
3) History of phlebitis, pulmonary embolism, intracranial infarction and coronary diseases
4) History of severe heart disease and renal diseases
5) Patients with active peptic ulcer
6) Psychiatric illness that makes it undesirable for the subject to participate in the trial
7) Evidence of any other significant disorder that make it undesirable for enrollment
80
1st name | |
Middle name | |
Last name | Osamu Ogawa |
Kyoto University, Graduate School of Medicine
Urology
54 Kawaharacho Shogoin Sakyoku Kyoto
075-751-3337
ogawao@kuhp.kyoto-u.ac.jp
1st name | |
Middle name | |
Last name | Takahiro Inoue |
Kyoto University, Graduate School of Medicine
Urology
54 Kawaharacho Shogoin Sakyoku Kyoto
075-751-3337
takahi@kuhp.kyoto-u.ac.jp
Kyoto University Hospital
Department account fund
Self funding
NO
京都大学医学部附属病院(京都府)
2010 | Year | 10 | Month | 18 | Day |
Published
Completed
2010 | Year | 10 | Month | 18 | Day |
2010 | Year | 10 | Month | 01 | Day |
2015 | Year | 12 | Month | 30 | Day |
2016 | Year | 01 | Month | 31 | Day |
2016 | Year | 01 | Month | 31 | Day |
2016 | Year | 03 | Month | 30 | Day |
2010 | Year | 10 | Month | 18 | Day |
2016 | Year | 08 | Month | 28 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005261
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