UMIN-CTR Clinical Trial

Basic information
Public title	Clinical study to evaluate the effectiveness of rectal culture before prostate biopsy to prevent postoperative bacterial prostatitis, multicenter, randomized controlled trial in Japan
Acronym	PROJECT trial
Scientific Title	Clinical study to evaluate the effectiveness of rectal culture before prostate biopsy to prevent postoperative bacterial prostatitis, multicenter, randomized controlled trial in Japan
Scientific Title:Acronym	PROJECT trial
Region	Japan

Condition
Condition	acute bacterial prostatitis
Classification by specialty	Urology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To confirm the effectiveness of rectal culture before prostate biopsy for preventing postoperative bacterial prostatitis, using selective media.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Phase III

Assessment
Primary outcomes	Incidence rate of acute bacterial prostatitis.
Key secondary outcomes	Sensitivity and specificity of simple medium, severity at the onset of prostatitis.

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	arm using selective media for rectal cultoure Culture from rectal swab is evaluated before prostate biopsy. If resistant bacteria are confirmed, piperacin/tazobactam 4.5g will administered 30 minutes before biopsy and 4 hours after biopsy. If not detected, levofloxacin 500mg is orally given 30minutes before biopsy.
Interventions/Control_2	control arem levofloxacin 500mg is orally given 30minutes before biopsy.
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.Patients who are scheduled for transrectal prostate biopsy with suspected prostate cancer. 2. Written informed consent
Key exclusion criteria	1, High risk for infection Prostate volume 75ml over Diabetes mellitus Patients receiving steroids Severe lower urinary tract symptoms Immunodeficiency 2, Transperineal prostate biopsy
Target sample size	5000

Research contact person
Name of lead principal investigator	1st name Takuya Middle name Last name Sadahira
Organization	Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Science
Division name	Urology
Zip code	700-8558
Address	2-5-1, Shikata-cho, Kita-ku, Okayama, Japan
TEL	086-235-7287
Email	t.sadahira@gmail.com

Public contact
Name of contact person	1st name Yuki Middle name Last name Maruyama
Organization	Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Science
Division name	Urology
Zip code	700-8558
Address	2-5-1, Shikata-cho, Kita-ku, Okayama, Japan
TEL	086-235-7287
Homepage URL
Email	eat.the.lobster@gmail.com

Sponsor
Institute	Okayama University
Institute
Department

Funding Source
Organization	Japanese Research Group for Urinary Tract Infection
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences and Okayama University Hospital, Ethics Committee
Address	2-5-1, Shikata-cho, Kita-ku, Okayama, Japan
Tel	086-235-6938
Email	mae6605@dm.okayama-u.ac.jp

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	2020 Year 02 Month 14 Day

Related information
URL releasing protocol
Publication of results	Unpublished

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	Preinitiation
Date of protocol fixation	2020 Year 02 Month 14 Day
Date of IRB
Anticipated trial start date	2020 Year 04 Month 01 Day
Last follow-up date	2025 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2020 Year 02 Month 14 Day
Last modified on	2020 Year 02 Month 14 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045014