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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000036940
Receipt No. R000041559
Scientific Title prostate biopsy based on transrectal ultrasound and MRI fusion imaging
Date of disclosure of the study information 2019/08/01
Last modified on 2019/12/04

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Basic information
Public title Examination about the usefulness in cancer localization diagnosis of prostate biopsy using BioJet system phase 4 study
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,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes a) Biopsy positive rate
b) Comparison of prostate biopsy 3D records and specimens in patients undergoing radical prostatectomy
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 Diagnosis
Type of intervention
Maneuver
Interventions/Control_1 Prostate biopsy with BioJet
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 4.0 ng / ml and 20 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> 20 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 75

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, okayama city, okayama
TEL 086-235-7287
Email p1v91oga@okayama-u.ac.jp

Public contact
Name of contact person
1st name Atsushi
Middle name
Last name Takamoto
Organization Okayama University Hospital
Division name Department of Urology
Zip code 7008558
Address kita-ku, shikata-tyo, 2-5-1, okayama city, okayama
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 Self funding
Nationality of Funding Organization Okayama University Hospital

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

IRB Contact (For public release)
Organization Okayama University Hospital
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 08 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 Open public recruiting
Date of protocol fixation
2019 Year 06 Month 03 Day
Date of IRB
2019 Year 07 Month 23 Day
Anticipated trial start date
2019 Year 10 Month 01 Day
Last follow-up date
2021 Year 03 Month 31 Day
Date of closure to data entry
2021 Year 12 Month 31 Day
Date trial data considered complete
2022 Year 02 Month 28 Day
Date analysis concluded
2022 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date
2019 Year 06 Month 03 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/ctr_e/ctr_view.cgi?recptno=R000041559

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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