UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002298 |
|---|---|
| Receipt number | 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 15:06:38 |
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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
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
ktabata@med.kitasato-u.ac.jp
Sponsor or person
Institute
Kitasato University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002748
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