UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The clinical study of the safety and efficacy of docetaxel combined with ribavirin in docetaxel resistant castration resistant prostate cancer
Title of the study (Brief title)	The clinical study of the safety and efficacy of docetaxel combined with ribavirin in docetaxel resistant castration resistant prostate cancer
Region	Japan

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

Objectives
Narrative objectives1	To evaluate the efficacy and safety of docetaxel with ribavirin in patients with progressive PCa
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	PSA response rate rPFS safety
Key secondary outcomes	OS

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Ribavirin
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	30 years-old <=
Age-upper limit	96 years-old >
Gender	Male
Key inclusion criteria	Adenocarcinoma of the prostate histologically confirmed Progressive Prostate cancer based on PSA and/or radiographic criteria. Stable medical condition, including the absence of severe hepatological, cardiac renal and hematological disorder etc
Key exclusion criteria	Uncontroled general complication. Diagnosis of or treatment for another systemic malignancy. etc
Target sample size	20

Research contact person
Name of lead principal investigator	Takeo Kosaka
Organization	Keio University School of Medicine
Division name	Department of Urology
Address	35 Shinjuku-ku, Tokyo 160-8582, Japan
TEL	03-3353-1211
Email	moto-oya@z3.keio.jp

Public contact
Name of contact person	Takeo Kosaka
Organization	Keio University School of Medicine
Division name	Department of Urology
Address	35 Shinjuku-ku, Tokyo 160-8582, Japan
TEL	03-3353-1211
Homepage URL
Email	takemduro@a6.keio.jp

Sponsor
Institute	Keio University School of Medicine, Department of Urology
Institute
Department

Funding Source
Organization	self funding
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

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

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	慶應義塾大学病院

Other administrative information
Date of disclosure of the study information	2014 Year 09 Month 12 Day

Progress
Recruitment status	Main results already published
Date of protocol fixation	2013 Year 12 Month 11 Day
Anticipated trial start date	2013 Year 12 Month 25 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	Partially published
URL releasing results
Results
Other related information

Management information
Registered date	2014 Year 09 Month 11 Day
Last modified on	2018 Year 10 Month 10 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014510