UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044363 |
|---|---|
| Receipt number | R000050667 |
| Scientific Title | MRI/ultrasound fusion-guided prostate needle biopsy |
| Date of disclosure of the study information | 2021/06/01 |
| Last modified on | 2021/05/28 19:18:20 |
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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
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
tfujita@med.nagoya-u.ac.jp
Sponsor or person
Institute
Nagoya University Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050667
