UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	MRI/TRUS fusion target biopsy against prostate cancer using real-time virtual sonography
Title of the study (Brief title)	RVS fusion target biopsy against prostate cancer
Region	Japan

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

Objectives
Narrative objectives1	To examine the efficacy and efficiency of the prostate biopsy using real-time virtual sonography against patients suspicious of prostate cancer compared to systematic biopsy
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Cancer-detected rates of the targeted biopsy compared to systematic biopsy
Key secondary outcomes

Base
Study type	Interventional

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

Intervention
No. of arms	2
Purpose of intervention	Diagnosis
Type of intervention	Device,equipment
Interventions/Control_1	Real-time virtual sonography (target biopsy)
Interventions/Control_2	systematic 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	40 years-old <=
Age-upper limit	80 years-old >
Gender	Male
Key inclusion criteria	1) PSA level (2.5-20ng/ml) 2) Suspicious of localized prostate cancer by digital rectal examination 3) Suspicious of localized prostate cancer by MRI (PI-RADS score >=3) 4) patients who was obtained informed consent
Key exclusion criteria	1) Suspicious of invasive prostate cancer by digital rectal examination 2) Suspicious of invasive prostate cancer by MRI 3) Patients with coagulation disorder 4) Patients who can not be performed TRUS because of anal stenosis
Target sample size	275

Research contact person
Name of lead principal investigator	Shuzo Hamamoto
Organization	Nagoya City University Graduate School of Medical Sciences
Division name	Nephro-urology
Address	1 Kawasumi Muzuho-cho, Mizuho-Ku, Nagoya, Japan
TEL	052-853-8266
Email	hamamo10@med.nagoya-cu.ac.jp

Public contact
Name of contact person	Shuzo Hamamoto
Organization	Nagoya City University Graduate School of Medical Sciences
Division name	Nephro-urology
Address	1 Kawasumi Muzuho-cho, Mizuho-Ku, Nagoya, Japan
TEL	052-853-8266
Homepage URL
Email	hamamo10@med.nagoya-cu.ac.jp

Sponsor
Institute	Nagoya City University Graduate School of Medical Sciences
Institute
Department

Funding Source
Organization	Nagoya City University Graduate School of Medical Sciences
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

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

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 03 Month 27 Day

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2017 Year 03 Month 26 Day
Anticipated trial start date	2017 Year 03 Month 27 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2017 Year 03 Month 26 Day
Last modified on	2017 Year 03 Month 26 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030663