UMIN-CTR Clinical Trial

Basic information
Public title	Evaluation of the efficacy of the detection of the significant cancer and the safety in MRI-TRUS fusion image-guided prostate biopsy: multi-institutional study in Japan
Acronym	Evaluation of the efficacy of the detection of the significant cancer and the safety in MRI-TRUS fusion image-guided prostate biopsy: multi-institutional study in Japan
Scientific Title	Evaluation of the efficacy of the detection of the significant cancer and the safety in MRI-TRUS fusion image-guided prostate biopsy: multi-institutional study in Japan
Scientific Title:Acronym	Evaluation of the efficacy of the detection of the significant cancer and the safety in MRI-TRUS fusion image-guided prostate biopsy: multi-institutional study in Japan
Region	Japan

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

Objectives
Narrative objectives1	To evaluate the efficacy of the detection of the significant cancer and the safety in MRI-TRUS fusion image-guided prostate biopsy
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Detection of the significant cancer in the patients and biopsy cores of systematic and target biopsies
Key secondary outcomes	a) cancer core length, cancer core percentage, and Gleason score in the biopsy cores of systematic and target biopsies b) the relation between the PI-RADS category, cancer core length, cancer core percentage, and Gleason score in the biopsy cores of target biopsies c) examination time c-1) time for segmentaion c-2) time for anesthesia c-3) time for the entire examination time for target biopsy time for systematic biopsy c-4) operating room usage time d) extension of hospital stay, and the reason e) emergency outpatient consultation, and the reason f) analysis using whole gland specimens for the detecion of significant cancer in systematic and target biopsy Safety Pain in the biopsy site, bleeding from the biopsy site, infection in the biopsy site, urinary tract infection, macroscopic hematuria, fever, urinary retension, and other (Grades of the complications would be evaluated with Common Terminology Criteria for Adverse Events (CTCAE) v5.0)

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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	1. the patients with and less tha PSA 20ng/mL 2. the patients who are suspected as having prostate cancer 3. the patients who agreed with the informaed consent of the present study
Key exclusion criteria	1. the patiens who have fatal disease 2. the patiens who are suspected as having progressive prostate cancer 3. the patiens who are suspected as having progressive prostate cancer with digital rectal examination 4. the patiens who are suspected as having progressive prostate cancer on MRI 5. the patiens who have abnormal blood coagulation 6. the patients who have the allergy for the anesthesia 7. the patients who were regarded as being inappropriate 8. the person with less than 20 years olds
Target sample size	400

Research contact person
Name of lead principal investigator	1st name Sunao Middle name Last name Shoji
Organization	Tokai University School of Medicine
Division name	Department of Urology
Zip code	259-1193
Address	143 Shimokasuya, Isehara, Kanagawa
TEL	+81-463-93-1121
Email	sunashoj@mail.goo.ne.jp

Public contact
Name of contact person	1st name Sunao Middle name Last name Shoji
Organization	Tokai University School of Medicine
Division name	Department of Urology
Zip code	259-1193
Address	143 Shimokasuya, Isehara, Kanagawa
TEL	+81-463-93-1121
Homepage URL
Email	sunashoj@mail.goo.ne.jp

Sponsor
Institute	Tokai University
Institute
Department

Funding Source
Organization	Tokai University
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor	Kanazawa Medical University, Saiseikai Kawaguchi General Hospital, Nagoya City University, The Jikei University School of Medicine, Okayama University, Juntendo University, KKR Takamatsu Hospital, Kyoto University, Nara Medical University, Hirosaki University, Public Central Hospital of Matto Ishikawa, Mimihara General Hospital, Takeda General Hospital, Tokyo Metropolitan Cancer and Infectious diseases Center Komagome Hospital
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Tokai University School of Medicine, Institutional Review Board for Clinical Research
Address	143 Shimokasuya, Isehara, Kanagawa
Tel	+81-463-93-1121
Email	ka134352@tsc.u-tokai.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	東海大学医学部付属病院(神奈川県), 金沢医科大学病院(石川県), 済生会川口総合病院(埼玉県), 名古屋市立大学病院(愛知県), 東京慈恵会医科大学病院(東京都), 岡山大学病院(岡山県), 順天堂大学順天堂医院(東京都), KKR高松病院(香川県), 京都大学病院(京都府), 奈良県立医科大学病院(奈良県), 弘前大学病院(青森県), 公立松任石川中央病院(石川県), 耳原総合病院(大阪府), 竹田綜合病院(福島県), がん・感染症センター 都立駒込病院(東京都)

Other administrative information
Date of disclosure of the study information	2020 Year 11 Month 09 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	No longer recruiting
Date of protocol fixation	2020 Year 10 Month 29 Day
Date of IRB	2020 Year 10 Month 29 Day
Anticipated trial start date	2020 Year 11 Month 09 Day
Last follow-up date	2021 Year 11 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	The objectives of the present study is to evaluate the efficacy of the detection of the significant cancer and the safety in MRI-TRUS fusion image-guided prostate biopsy in multi-institutional study in Japan.

Management information
Registered date	2020 Year 11 Month 09 Day
Last modified on	2022 Year 04 Month 11 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048397