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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000004709
Receipt No. 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

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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
Email 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
Email mitsuzuka@uro.med.tohoku.ac.jp

Sponsor
Institute Tohoku University, Dept. of urology
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005604

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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