UMIN-CTR Clinical Trial

Basic information
Public title	A study of safety and efficacy of three-dimensional prostate biopsy method for patients with suspected prostate cancer
Acronym	A study of safety and efficacy of three-dimensional prostate biopsy method for patients with suspected prostate cancer
Scientific Title	A study of safety and efficacy of three-dimensional prostate biopsy method for patients with suspected prostate cancer
Scientific Title:Acronym	A study of safety and efficacy of three-dimensional prostate biopsy method for patients with suspected prostate cancer
Region	Japan

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

Objectives
Narrative objectives1	to evaluate the safety and efficacy of three-dimensional prostate biopsy method
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	cancer detection rate rate of occurrence of a complication
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	Maneuver
Interventions/Control_1	three-dimensional prostate biopsy
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	1.patients with susupected prostate cancer who had previously experience of prostate biopsies 2.patients who satisfied all of criteria as follows a)patients suspected prostate cancer at apex or ventral portion by MRI b)patients who have prostate volume more than 30ml c)patients who have prostate volume less than 30ml and have middle lobe enlargement
Key exclusion criteria	1.patients who cannot undergo lumbar spinal anesthesia 2.patients who decide not to join this study
Target sample size	200

Research contact person
Name of lead principal investigator	1st name Middle name Last name Takeo Kosaka
Organization	Keio University School of Medicine
Division name	Department of Urology
Zip code
Address	35, Shinanomachi, Shinjuku-ku, Tokyo
TEL	03-3353-1211
Email	takemduro@gmail.com

Public contact
Name of contact person	1st name Middle name Last name Hiroaki Kobayashi
Organization	Keio University School of Medicine
Division name	Department of Urology
Zip code
Address	35, Shinanomachi, Shinjuku-ku, Tokyo
TEL	03-3353-1211
Homepage URL
Email	shadow87jp@yahoo.co.jp

Sponsor
Institute	Department of Urology, Keio University School of Medicine
Institute
Department

Funding Source
Organization	Department of Urology, Keio University School of Medicine
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	2014 Year 10 Month 02 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	2014 Year 10 Month 02 Day
Date of IRB	2014 Year 09 Month 30 Day
Anticipated trial start date	2014 Year 10 Month 02 Day
Last follow-up date	2018 Year 09 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded	2018 Year 09 Month 30 Day

Other
Other related information

Management information
Registered date	2014 Year 10 Month 02 Day
Last modified on	2020 Year 10 Month 07 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000017826