UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000029102
Receipt number R000033249
Scientific Title Prostate biopsy with fusion imaging of magnetic resonance imaging and transrectal ultrasound
Date of disclosure of the study information 2017/09/12
Last modified on 2018/03/15 11:13:11

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Basic information

Public title

Prostate biopsy with fusion imaging of magnetic resonance imaging and transrectal ultrasound

Acronym

Prostate biopsy with fusion imaging of magnetic resonance imaging and transrectal ultrasound

Scientific Title

Prostate biopsy with fusion imaging of magnetic resonance imaging and transrectal ultrasound

Scientific Title:Acronym

Prostate biopsy with fusion imaging of magnetic resonance imaging and transrectal ultrasound

Region

Japan


Condition

Condition

Urology

Classification by specialty

Urology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the efficiency of transperineal targeted biopsy with real-time fusion image (BioJet system) of multiparametric-MRI (mpMRI) and transrectal ultrasound (TRUS) image for the diagnosis of significant prostate cancer.

Basic objectives2

Safety

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

We evaluate the number of adverse events, hematuria, prostatitis and cancer detection rate of transperineal targeted prostate biopsy with BioJet system compared to systematic biopsy.

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

Historical

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Diagnosis

Type of intervention

Device,equipment

Interventions/Control_1

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


Not applicable

Age-upper limit


Not applicable

Gender

Male

Key inclusion criteria

・Serum PSA level: 4.0-20.0ng/ml
・Localized prostate cancer was suspected
・Significant cancer was suspected by MRI
・To obtain consent

Key exclusion criteria

・Anal stenosis
・Diabetes
・Infection nest in perineum site
・Clear hypoechoic area was detected by US on cancer suspecting region

Target sample size

5


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Katsuhito Miyazawa

Organization

Kanazawa Medical University

Division name

Department of Urology

Zip code


Address

1-1, Daigaku, Uchinada, Kahoku, Ishikawa, 920-0293, Japan

TEL

076-286-2211

Email

miyazawa@kanazawa-med.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Ippei Chikazawa

Organization

Kanazawa Medical University

Division name

Department of Urology

Zip code


Address

1-1, Daigaku, Uchinada, Kahoku, Ishikawa, 920-0293, Japan

TEL

076-286-2211

Homepage URL


Email

i-chika@kanazawa-med.ac.jp


Sponsor or person

Institute

Kanazawa Medical University

Institute

Department

Personal name



Funding Source

Organization

Kanazawa Medical University

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



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

2017 Year 09 Month 12 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

2017 Year 08 Month 10 Day

Date of IRB


Anticipated trial start date

2017 Year 10 Month 01 Day

Last follow-up date


Date of closure to data entry

2018 Year 03 Month 13 Day

Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2017 Year 09 Month 12 Day

Last modified on

2018 Year 03 Month 15 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033249


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name