UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Clinical efficacy of prevention against infectious complication after transrectal prostate biopsy and molecular and microbiological analysis of rectal Escherichia coli with quinolone-resistance
Title of the study (Brief title)	Clinical efficacy of prevention against infectious complication after transrectal prostate biopsy
Region	Japan

Condition
Condition	suspected prostate cancer
Classification by specialty	Urology
Classification by malignancy	Malignancy
Genomic information	YES

Objectives
Narrative objectives1	To prevent the occurrence of acute bacterial prostatitis after transrectal prostate biopsy
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	prevention of acute bacterial prostatitis
Key secondary outcomes

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	quinolone-resistant E coli or not
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	suspected prostate cancer
Key exclusion criteria	none
Target sample size	1000

Research contact person
Name of lead principal investigator	Satoshi Takahashi
Organization	Sapporo Medical University
Division name	School of Medicine, Department of Urology
Address	S1, W16, Chuo-ku, Sapporo
TEL	011-611-2111
Email	stakahas@sapmed.ac.jp

Public contact
Name of contact person	Satoshi Takahashi
Organization	Sapporo Medical University
Division name	School of Medicine, Department of Urology
Address	S1, W16, Chuo-ku, Sapporo
TEL	011-611-2111
Homepage URL
Email	stakahas@sapmed.ac.jp

Sponsor
Institute	Department of Urology, Sapporo Medical University School of Medicine
Institute
Department

Funding Source
Organization	Department of Urology, Sapporo Medical University School of Medicine
Organization
Division
Category of Funding Organization	Self funding
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

Other administrative information
Date of disclosure of the study information	2013 Year 01 Month 11 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 01 Month 11 Day
Anticipated trial start date	2013 Year 04 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded	2017 Year 12 Month 01 Day

Related information
URL releasing protocol
Publication of results	Partially published
URL releasing results
Results
Other related information

Management information
Registered date	2013 Year 01 Month 11 Day
Last modified on	2019 Year 01 Month 16 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000011430