UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039478 |
|---|---|
| Receipt number | R000045014 |
| 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 |
| Date of disclosure of the study information | 2020/02/14 |
| Last modified on | 2020/02/14 18:40:37 |
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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
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
eat.the.lobster@gmail.com
Sponsor or person
Institute
Okayama University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045014
