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Recruitment status
Unique ID issued by UMIN UMIN000002298
Receipt No. R000002748
Scientific Title Randomized phaze II clinical trial of intermittent docetaxel plus prednisone for the treatment of hormone-refractory prostate cancer
Date of disclosure of the study information 2009/08/05
Last modified on 2009/08/05

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Basic information
Public title Randomized phaze II clinical trial of intermittent docetaxel plus prednisone for the treatment of hormone-refractory prostate cancer
Acronym Phase II intermittent docetaxel for hormone-refractory prostate cancer
Scientific Title Randomized phaze II clinical trial of intermittent docetaxel plus prednisone for the treatment of hormone-refractory prostate cancer
Scientific Title:Acronym Phase II intermittent docetaxel for hormone-refractory prostate cancer
Region
Japan

Condition
Condition prostate cancer
Classification by specialty
Urology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To assess improvement of quality of life (QOL) in intermittent Docetaxel(DTX) with Prednisolone(PSL) therapy for Japanese patients with hormone-refractory prostate cancer.
Basic objectives2 Others
Basic objectives -Others QOL
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes QOL (before administration of Docetaxel, every 3 weeks when chemotherapy is paused)
Key secondary outcomes Time to failure, Adverse Events, Overall mortality

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification YES
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking YES
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 docetaxel plus prednisolone
Interventions/Control_2 docetaxel
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

Not applicable
Gender Male
Key inclusion criteria 1) Histological proof of prostate adenocarcinoma.
2) Patient with HRPC, which was confirmed by failure of 2nd line hormone therapy and disease progression even after withdrawal of anti-androgen.
3) Serum PSA higher than 2ng/ml.
4) Life expectancy of at least 3 Months.
5) Patients with Performance Status (ECOG) 0-2.
6) No previous chemotherapy of taxane.
7) adequate organ function
a) WBC: larger or equal to 4,000/L and smaller or equal to 12,000/L
b) Neutro: larger or equal to 2,000/L
c) Plt: larger or equal to 100,000/L
d) Hb: larger or equal to 9.5g/dL
e) AST(GOT): smaller than 2.5x upper limit of normal
f) ALT(GPT): smaller than 2.5x upper limit of normal
g) Serum Cr: smaller than 1.5x upper limit of normal
h) SPO2: larger or equal to 90%
i) ECG: no evidence to need treatment

8) Patients must sign an informed consent indication that they are aware of the investigational nature of the study, in keeping with the policies of the institution.
Key exclusion criteria 1. active infection
2. history of previous radiotherapy to pelvis, severe comorbidity, history of any other malignancy which includes synchronal double cancer
3. chest Xray shows obvious interstitial pneumonia and pulmonary fibrosis
4. patients who have been included in another clinical trial less than 6 months before agreement of this trial
5. patients who are judged as unsuitable for the trial by the doctor in charge
Target sample size 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Ken-ichi Tabata
Organization Kitasato University
Division name Urology
Zip code
Address 1-15-1 kitasato, sagamihara city, Kanagawa
TEL +81-427-9091
Email

Public contact
Name of contact person
1st name
Middle name
Last name Ken-ichi Tabata
Organization Kitasato University
Division name Urology
Zip code
Address 1-15-1 kitasato, sagamihara city, Kanagawa
TEL +81-427-9091
Homepage URL
Email ktabata@med.kitasato-u.ac.jp

Sponsor
Institute Kitasato University
Institute
Department

Funding Source
Organization Self-funding
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

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

Other administrative information
Date of disclosure of the study information
2009 Year 08 Month 05 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
Date of protocol fixation
2009 Year 03 Month 01 Day
Date of IRB
Anticipated trial start date
2009 Year 06 Month 01 Day
Last follow-up date
2014 Year 01 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2009 Year 08 Month 05 Day
Last modified on
2009 Year 08 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002748

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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