Unique ID issued by UMIN | UMIN000002822 |
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Receipt number | R000003440 |
Scientific Title | Pilot study for randomized clinical trial of bicaltamide alone versus bicaltamide plus goserelin acetate in patients with PSA failure after radical prostatectomy |
Date of disclosure of the study information | 2009/12/02 |
Last modified on | 2019/12/09 10:00:11 |
Pilot study for randomized clinical trial of bicaltamide alone versus bicaltamide plus goserelin acetate in patients with PSA failure after radical prostatectomy
Pilot study for randomized clinical trial of androgen deprivation therapy in patients with PSA failure after radical prostatectomy
Pilot study for randomized clinical trial of bicaltamide alone versus bicaltamide plus goserelin acetate in patients with PSA failure after radical prostatectomy
Pilot study for randomized clinical trial of androgen deprivation therapy in patients with PSA failure after radical prostatectomy
Japan |
Prostate cancer
Urology |
Malignancy
NO
To determine whether bicalutamide alone is equally effective and safety to combined androgen blockade in patients with PSA failure after radical prostatectomy. The aim of this pilot study is to determine numbers of required patients.
Safety,Efficacy
Exploratory
Pragmatic
Phase III
Clinical relapse-free survival
1.Evaluation of quality of life (EPIC)
2.Rate of adverse events is evaluated based on the NCI-CTCAE (Ver.3)
3.Overall survival
4.Cause specific survival
5.PSA progression free survival
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
Active
YES
YES
Institution is not considered as adjustment factor.
NO
Central registration
2
Treatment
Medicine |
Patients are randomized to arm 1 or arm 2 according to age, PSA levels, Gleason score and institutes.
Arm 1. Bicaltamide alone
Daily oral bicaltamide 80 mg for 3 years.
Arm 2. Combined androgen brockade
LH-RH agonists (goserelin acetate 3.6 mg/month or 10.8 mg/3 months) with daily oral bicaltamide 80 mg for 3 years.
20 | years-old | <= |
85 | years-old | >= |
Male
The subjects must satisfy the following conditions.
1) Patients must be diagnosed as prostate cancer pathologically.
2) Patients must have a PSA level of 1.0 ng/ml after radical prostatectomy.
3) Patients did not receive any prior hormonal therapy as adjuvant or neo-adjuvant setting.
4) Patients must satisfy the followings:
WBC >= 2500/mm3
Lymphocyte >= 1000/mm3
Hb >= 8.0g/dl
Platelet >= 80000/mm3
Serum Creatinine <= 2.5 x upper limit of normal
Total Bilirubin <= 2 x upper limit of normal
5) Patients must be at a score level of 0-1 of performance status (PS) (EOCG)
6) Patients must be more 20 year-old.
7) Written informed consent must be obtained from patients.
The following patients must be excluded:
1) Patients with severe symptoms (active and severe infectious disease, circulatory disease, respiratory disease, kidney disease, immunodeficiency, disturbance of coagulation).
2) Patients with the past history of severe allergic reactions.
3) Patients do not accept contraception during the 1st vaccination to 70 days after the last vaccination.
4) Patients who are judged inappropriate for the clinical trial by doctors.
12
1st name | |
Middle name | |
Last name | Masanori Noguchi |
Kurume University
Research Center for Innovative Cancer Therapy, Division of Clinical Research
67 Asahi-machi, Kurume,
0942-31-7989
noguchi@med.kurume-u.ac.jp
1st name | |
Middle name | |
Last name | Akira Yamada |
Kurume University
Research Center for Innovative Cancer Therapy, Cancer Vaccine Development Division
67 Asahi-machi, Kurume,
0942-31-7744
akiymd@med.kurume-u.ac.jp
Cancer Research Center for Innovative cancer therapy,Kurume University School of medicine
Cancer Research Center for Innovative cancer therapy,Kurume University School of medicine
Self funding
Japan
Kurume University
NO
久留米大学病院(福岡県) Kurume University Hosptial(Fukuoka)
2009 | Year | 12 | Month | 02 | Day |
Unpublished
Terminated
2009 | Year | 04 | Month | 01 | Day |
2009 | Year | 06 | Month | 17 | Day |
2009 | Year | 12 | Month | 01 | Day |
2012 | Year | 03 | Month | 01 | Day |
2009 | Year | 12 | Month | 01 | Day |
2019 | Year | 12 | Month | 09 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003440
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