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UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000004096
Receipt No. 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

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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
Email 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
Email sendo@naramed-u.ac.jp

Sponsor
Institute The Japan-Multinational Trial Organization
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004896

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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