UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Optimization of prostate needle biopsy for focal targeted therapy in prostate cancer
Title of the study (Brief title)	Optimization of prostate needle biopsy for focal targeted therapy in prostate cancer
Region	Japan

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

Objectives
Narrative objectives1	To develop optimized methods to detect significant prostate cancer by image-guided needle biopsy
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Efficiency of detecting prostate cancer with gleason score 7 or higher from targeted regions
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	Targeted 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	20 years-old <=
Age-upper limit	Not applicable
Gender	Male
Key inclusion criteria	Male patients suspicious of cancer who have targeted region with PI-RADS score 3 or more by MRI
Key exclusion criteria	Patients with a contraindication for the administration of gadolinium contrast media. Patients determined to be ineligible to principal investigator
Target sample size	50

Research contact person
Name of lead principal investigator	Osamu Ukimura
Organization	Kyoto Prefectural University of Medicine
Division name	Department of Urology
Address	465 Kajii-cho Kamigyo-ku Kyoto 602-8566 Japan
TEL	075-251-5595
Email	ukimura@koto.kpu-m.ac.jp

Public contact
Name of contact person	Takumi Shiraishi
Organization	Kyoto Prefectural University of Medicine
Division name	Department of Urology
Address	465 Kajii-cho Kamigyo-ku Kyoto 602-8566 Japan
TEL	075-251-5595
Homepage URL
Email	takumi14@koto.kpu-m.ac.jp

Sponsor
Institute	Kyoto Prefectural University of Medicine
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor	Kyoto Min-iren Chuo Hospital
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	京都府立医科大学付属病院（京都府）

Other administrative information
Date of disclosure of the study information	2017 Year 09 Month 23 Day

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2017 Year 09 Month 01 Day
Anticipated trial start date	2017 Year 10 Month 01 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 09 Month 21 Day
Last modified on	2017 Year 09 Month 21 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033403