UMIN-CTR Clinical Trial
| 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 |
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Basic information
Public title
Multi-center study to evaluate long-term influences on lipid metabolism in prostate cancer patients who received androgen deprivation therapy.
Acronym
Multi-center study to evaluate long-term influences on lipid metabolism in prostate cancer patients who received androgen deprivation therapy.
Scientific Title
Multi-center study to evaluate long-term influences on lipid metabolism in prostate cancer patients who received androgen deprivation therapy.
Scientific Title:Acronym
Multi-center study to evaluate long-term influences on lipid metabolism in prostate cancer patients who received androgen deprivation therapy.
Region
| Japan |
Condition
Condition
Prostate cancer
Classification by specialty
| Urology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
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.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
Percent change in serum lipid (total cholesterol, triglyceride, HDL and LDL-cholesterol)
Key secondary outcomes
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
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 85 | years-old | >= |
Gender
Male
Key inclusion criteria
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
Key exclusion criteria
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
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoichi Arai |
Organization
Tohoku University, Dept. of urology
Division name
Urology
Zip code
Address
Seiryo-machi 1-1 Aoba-ku Sendai Miyagi 980-8574 Japan
TEL
022-717-7278
yarai@uro.med.tohoku.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Koji Mitsuzuka |
Organization
Tohoku University, Dept. of urology
Division name
Urology
Zip code
Address
Seiryo-machi 1-1 Aoba-ku Sendai Miyagi 980-8574 Japan
TEL
022-717-7278
Homepage URL
mitsuzuka@uro.med.tohoku.ac.jp
Sponsor or person
Institute
Tohoku University, Dept. of urology
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Hirosaki University, Dept. of urology
Akita University, Dept. of urology
Ryukyu University, Dept. of urology
Name of secondary funder(s)
None
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
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）
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 01 | Month | 15 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Open public recruiting
Date of protocol fixation
| 2010 | Year | 10 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2014 | Year | 10 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2015 | Year | 03 | Month | 31 | Day |
Other
Other related information
None
Management information
Registered date
| 2010 | Year | 12 | Month | 12 | Day |
Last modified on
| 2014 | Year | 06 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005604
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