Unique ID issued by UMIN | UMIN000004709 |
---|---|
Receipt number | R000005604 |
Scientific Title | Multi-center study to evaluate long-term influences on lipid metabolism in prostate cancer patients who received androgen deprivation therapy. |
Date of disclosure of the study information | 2011/01/15 |
Last modified on | 2014/06/12 21:29:47 |
Multi-center study to evaluate long-term influences on lipid metabolism in prostate cancer patients who received androgen deprivation therapy.
Multi-center study to evaluate long-term influences on lipid metabolism in prostate cancer patients who received androgen deprivation therapy.
Multi-center study to evaluate long-term influences on lipid metabolism in prostate cancer patients who received androgen deprivation therapy.
Multi-center study to evaluate long-term influences on lipid metabolism in prostate cancer patients who received androgen deprivation therapy.
Japan |
Prostate cancer
Urology |
Malignancy
NO
To evaluate the effect of androgen deprivation therapy on lipid metabolism (total cholesterol, triglyceride, HDL-cholesterol, LDL-cholesterol) in hormone naïve patients with prostate cancer.
Safety
Exploratory
Pragmatic
Phase II
Percent change in serum lipid (total cholesterol, triglyceride, HDL and LDL-cholesterol)
1. Percent change in fasting serum glucose.
2. Changes in body weight, waist circumference and body mass index (BMI).
3. Changes in abdominal fat area
4. Adverse events
Observational
20 | years-old | <= |
85 | years-old | >= |
Male
1) Clinically T1-4 patient of prostate cancer(anyN, anyM)
2) No previous hormonal treatment.
3) Performance status 0-1 (ECOG)
4) Patients who satisfy the following
a) WBC>3.0x103/uL
b) hemoglobin>10.0 g/dL
c) platelet>10x104/uL
d) serum creatinine<2.0 mg/dL
e) AST100<IU/L
f) ALT100<IU/L
5) Patients who will receive hormonal therapy more than 1 year
6) 20<Age<85 years/old
7) Written informed consent
1) Patients who have active another cancer
2) serious cardiovascular disease
3) uncontrollable diabetes
4) patients with hyperthyroidism, cushing syndrome, nephrotic syndrome
5) treated with estrogen (eg. Ethinylestradiol, estramustine)
6) treated with antiandrogen (eg. prostal) for benign prostatic hyperplasia
7) treated with 5alpha-reductase inhibitor (eg. dutasteride) for benign prostatic hyperplasia
8) treated with steroids (exclude external use for skin)
9) treated with other anticancer drugs
10) Patient who enrolled other clinical studies.
11) Patients who considered inappropriate for this trial by physicians
200
1st name | |
Middle name | |
Last name | Yoichi Arai |
Tohoku University, Dept. of urology
Urology
Seiryo-machi 1-1 Aoba-ku Sendai Miyagi 980-8574 Japan
022-717-7278
yarai@uro.med.tohoku.ac.jp
1st name | |
Middle name | |
Last name | Koji Mitsuzuka |
Tohoku University, Dept. of urology
Urology
Seiryo-machi 1-1 Aoba-ku Sendai Miyagi 980-8574 Japan
022-717-7278
mitsuzuka@uro.med.tohoku.ac.jp
Tohoku University, Dept. of urology
None
Self funding
Hirosaki University, Dept. of urology
Akita University, Dept. of urology
Ryukyu University, Dept. of urology
None
NO
弘前大学医学部(青森県)
秋田大学医学部(秋田県)
琉球大学医学部(沖縄県)
2011 | Year | 01 | Month | 15 | Day |
Unpublished
Open public recruiting
2010 | Year | 10 | Month | 15 | Day |
2010 | Year | 11 | Month | 01 | Day |
2014 | Year | 10 | Month | 01 | Day |
2015 | Year | 03 | Month | 31 | Day |
None
2010 | Year | 12 | Month | 12 | Day |
2014 | Year | 06 | Month | 12 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005604