UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004096 |
|---|---|
| Receipt number | R000004896 |
| Scientific Title | A study to evaluate efficacy and safety of docetaxel combined with dexamethasone in patients with hormone refractory prostate cancer; JMTO PCa10-01 |
| Date of disclosure of the study information | 2010/09/01 |
| Last modified on | 2018/05/29 19:37:55 |
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Basic information
Public title
A study to evaluate efficacy and safety of docetaxel combined with dexamethasone in patients with hormone refractory prostate cancer; JMTO PCa10-01
Acronym
A study of docetaxel and dexamethason for hormone refractory prostate cancer; JMTO PCa10-01
Scientific Title
A study to evaluate efficacy and safety of docetaxel combined with dexamethasone in patients with hormone refractory prostate cancer; JMTO PCa10-01
Scientific Title:Acronym
A study of docetaxel and dexamethason for hormone refractory prostate cancer; JMTO PCa10-01
Region
| Japan |
Condition
Condition
prostate cancer
Classification by specialty
| Urology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Evaluation for efficacy as 50% declining of PSA value with combination of docetaxel (75 mg/m2) and dexamethasone for hormone refractory prostate cancer.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Assessment
Primary outcomes
PSA response defined as a reduction in serum PSA levels of at least 50%
Key secondary outcomes
Safety, PSA flare, time to PSA failure
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Docetaxel 75 mg/m2 i.v. q3w, up to 10 cycles + dexamethason 1.0 mg/day p.o. daily.
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
| Not applicable |
Gender
Male
Key inclusion criteria
1. Advanced or recurrent prostate cancer during or after surgical or medical castration.
2. ECOG performance status: 0 or 1.
3. Adequate organ functions:
; Neutrophils:;1,500/mm3.
; WBC:;3,000/mm3.
; Platelets: ;75,000/mm3.
; Hemoglobin:;9.0g/dL.
; AST: <2.5x Upper limit of normal (ULN).
; ALT: <2.5x ULN.
; Total bililbine: <ULN.
; Serum creatinine: <1.5x ULN.
4. Acceptable sufficient contraception.
5. Age:;20 years old at the time of enrollment.
6. Obtaining written informed consent.
Key exclusion criteria
1. No prior cyto-toxic chemotherapy and/or molecular targeting therapy, including mono-therapy of estramustine.
2. Infection.
3. Fever with suspicion of infectious disease.
4. Interstitial pneumonitis and pulmonary fibrosis.
Target sample size
75
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshihiko Hirao |
Organization
Nara Medical University
Division name
Department of Urology
Zip code
Address
840 Shijocho, Kashihara, Nara, Japan
TEL
0744-22-3051
seno@naramed-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Nobumichi Tanaka |
Organization
Nara Medical University
Division name
Department of Urology
Zip code
Address
840 Shijocho kashihara, Nara, Japan
TEL
0744-22-3051
Homepage URL
sendo@naramed-u.ac.jp
Sponsor or person
Institute
The Japan-Multinational Trial Organization
Institute
Department
Personal name
Funding Source
Organization
The Japan-Multinational Trial Organization
Organization
Division
Category of Funding Organization
Non profit foundation
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
YES
Study ID_1
JMTO PCa10-01
Org. issuing International ID_1
The Japan-Multinational Trial Organization
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 09 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Published
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
Main results already published
Date of protocol fixation
| 2010 | Year | 06 | Month | 22 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 09 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2010 | Year | 08 | Month | 24 | Day |
Last modified on
| 2018 | Year | 05 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004896
