UMIN-CTR Clinical Trial

Basic information
Public title	MRI/ultrasound fusion-guided prostate needle biopsy
Acronym	MRI/ultrasound fusion-guided prostate needle biopsy
Scientific Title	MRI/ultrasound fusion-guided prostate needle biopsy
Scientific Title:Acronym	MRI/ultrasound fusion-guided prostate needle biopsy
Region	Japan

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

Objectives
Narrative objectives1	To evaluate whether a perineal prostate needle biopsy using a Biojet system that fuses prostate MRI images with real-time prostate echo images is useful as a system for detecting Significant Cancers (Cancer with a tumor volume of 0.5 mm3 or more, Cancer with a Gleason score of 3+4 or more or Cancer with Gleason score of 3+3 with a length of 4 mm or more in biopsy tissue) with higher sensitivity and specificity than regular biopsies.
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Detection rate of Significant Cancer in transperineal prostate needle biopsy by Biojet system
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	Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Diagnosis
Type of intervention	Maneuver
Interventions/Control_1	Perform a transperineal prostate needle biopsy the day after admission.
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	80 years-old >
Gender	Male
Key inclusion criteria	Patients with localized prostate cancer with a serum PSA level of >4.0 ng / mL and <20 ng / ml, suspected of having Significant cancer by MRI.
Key exclusion criteria	Exclude patients who do not meet the above eligibility criteria. Patients who have difficulty inserting a transrectal ultrasound probe due to anal stenosis. Diabetic patients who are positive for urinary ketone bodies, have fasting blood glucose of 200 mg / dL or higher, and have postprandial blood glucose of 300 mg / dL or higher. Patients with a foci of infection in the perineum, which is the puncture site. Patients with lesions of a diameter of 10 mm or more on MRI which detected on transrectal ultrasonography and judged to be easy to biopsy by urologist.
Target sample size	50

Research contact person
Name of lead principal investigator	1st name Takashi Middle name Last name Fujita
Organization	Nagoya University Hospital
Division name	Urology
Zip code	466-8560
Address	65 Tsurumai-cho, Showa-ku, Nagoya
TEL	052-774-2984
Email	tfujita@med.nagoya-u.ac.jp

Public contact
Name of contact person	1st name Takashi Middle name Last name Fujita
Organization	Nagoya University Graduate School of Medicine
Division name	Urology
Zip code	466-8560
Address	65 Tsurumai-cho, Showa-ku, Nagoya
TEL	052-744-2984
Homepage URL
Email	tfujita@med.nagoya-u.ac.jp

Sponsor
Institute	Nagoya University Hospital
Institute
Department

Funding Source
Organization	none
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Nagoya University Medical Research and Clinical Ethics Promotion Office
Address	65 Tsurumaicho, Showa-ku, Nagoya
Tel	052-744-2061
Email	ethics@med.nagoya-u.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

Other administrative information
Date of disclosure of the study information	2021 Year 06 Month 01 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	Preinitiation
Date of protocol fixation	2021 Year 06 Month 01 Day
Date of IRB
Anticipated trial start date	2021 Year 06 Month 01 Day
Last follow-up date	2026 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2021 Year 05 Month 28 Day
Last modified on	2021 Year 05 Month 28 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050667