UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A study to evaluate efficacy and safety of docetaxel combined with dexamethasone in patients with hormone refractory prostate cancer; JMTO PCa10-01
Title of the study (Brief title)	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	Yoshihiko Hirao
Organization	Nara Medical University
Division name	Department of Urology
Address	840 Shijocho, Kashihara, Nara, Japan
TEL	0744-22-3051
Email	seno@naramed-u.ac.jp

Public contact
Name of contact person	Nobumichi Tanaka
Organization	Nara Medical University
Division name	Department of Urology
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)

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

Progress
Recruitment status	Main results already published
Date of protocol fixation	2010 Year 06 Month 22 Day
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

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000004896