UMIN-CTR Clinical Trial

Basic information
Public title	Examination about the usefulness in cancer localization diagnosis of prostate biopsy using BioJet system
Acronym	Biojet prostate biopsy
Scientific Title	prostate biopsy based on transrectal ultrasound and MRI fusion imaging
Scientific Title:Acronym	MRI-US fusion prostate biopsy
Region	Japan

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

Objectives
Narrative objectives1	The purpose of this study is to investigate whether prostate biopsy performed using the BioJet system can improve diagnostic rates and accurate prostate cancer localization.
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Biopsy positive rate
Key secondary outcomes	safety such as bleeding, infection after biopsy

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	Diagnosis
Type of intervention	Device,equipment
Interventions/Control_1	Prostate biopsy using biojet system
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	85 years-old >
Gender	Male
Key inclusion criteria	Target patients who meet all the following criteria 1) Patients with serum PSA level between 2.5 ng / ml and 50 ng / ml 2) PIRADS score 3 or more on MRI before biopsy 3) Patients 20 years of age or older at the time of consent acquisition 4) Patients who obtained written consent by the patient's own free will after sufficient understanding after participating in this study
Key exclusion criteria	I. A patient who is judged not to contribute to a patient's life prognosis by a definite diagnosis of prostate cancer II. Patients suspected of developing prostate cancer with serum PSA> 50 ng / ml III. Patients suspected of having advanced prostate cancer by rectal examination IV. Patients suspected of having advanced prostate cancer by MRI V. Patients who can not have prostate biopsy due to blood coagulation abnormality VI. Patients who can not be under spinal anesthesia, sacral anesthesia or general anesthesia because they have allergies to anesthetic agents VII. Other patients who were judged inappropriate by the doctor in charge of this study
Target sample size	5

Research contact person
Name of lead principal investigator	1st name ATSUSHI Middle name Last name TAKAMOATO
Organization	Okayama University Hospital
Division name	Department of Urology
Zip code	7008558
Address	kita-ku, shikata-tyo, 2-5-1
TEL	0862357287
Email	p1v91oga@okayama-u.ac.jp

Public contact
Name of contact person	1st name takamoto Middle name Last name atsushi
Organization	Okayama University Hospital
Division name	Department of urology
Zip code	7008558
Address	kita-ku, shikata-tyo, 2-5-1
TEL	0862357287
Homepage URL
Email	p1v91oga@okayama-u.ac.jp

Sponsor
Institute	Okayama University Hospital
Institute
Department

Funding Source
Organization	Okayama University Hospital
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 Hospital Department of urology
Address	kita-ku, shikata-tyo, 2-5-1
Tel	0862357287
Email	p1v91oga@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	2019 Year 07 Month 01 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	Completed
Date of protocol fixation	2019 Year 06 Month 03 Day
Date of IRB	2019 Year 06 Month 25 Day
Anticipated trial start date	2019 Year 07 Month 01 Day
Last follow-up date	2019 Year 08 Month 31 Day
Date of closure to data entry	2019 Year 08 Month 31 Day
Date trial data considered complete	2019 Year 08 Month 31 Day
Date analysis concluded	2019 Year 09 Month 30 Day

Other
Other related information

Management information
Registered date	2019 Year 06 Month 11 Day
Last modified on	2019 Year 12 Month 04 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000042181