UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050631 |
|---|---|
| Receipt number | R000057673 |
| Scientific Title | Detection of clinically significant prostate cancer with MRI-TRUS fusion image-guided biopsy: comparison of the evaluation system (PI-RADS category vs. PI-RADS + US evalutaion) |
| Date of disclosure of the study information | 2023/03/20 |
| Last modified on | 2023/03/19 17:14:18 |
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Basic information
Public title
Detection of clinically significant prostate cancer with MRI-TRUS fusion image-guided biopsy: comparison of the evaluation system (PI-RADS category vs. PI-RADS + US evalutaion)
Acronym
Detection of clinically significant prostate cancer with MRI-TRUS fusion image-guided biopsy
Scientific Title
Detection of clinically significant prostate cancer with MRI-TRUS fusion image-guided biopsy: comparison of the evaluation system (PI-RADS category vs. PI-RADS + US evalutaion)
Scientific Title:Acronym
Detection of clinically significant prostate cancer with MRI-TRUS fusion image-guided biopsy
Region
| Japan |
Condition
Condition
Suspected prostate cancer
Classification by specialty
| Urology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objectives of the present study is to compare the detection of clinically significant prostate cancer with MRI-TRUS fusion image-guided biopsy in the evaluation system between PI-RADS category and PI-RADS + US evalutaion.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Significant cancer detection
Key secondary outcomes
1. Evaluation time of ultrasound
2. Revision rates of PI-RADS+US category from PI-RADS category
3. Difference of significant cancer detections between target and systematic biopsies
4. Safety (CTCAE v.5.0) during procedure and within 1 month after the procedure
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
| Device,equipment |
Interventions/Control_1
Ultrasound imaging (gray scale, Doppler, elastography)
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
| 90 | years-old | > |
Gender
Male
Key inclusion criteria
Patients with PSA value and less than 20 ng/mL
Patients who were suspected as having prostate significant cancer on MRI (with and larger than PI-RADS category 3)
Patients who will be performed MRI-TRUS fusion image-guided biopsy and systematic biopsy with trans-perineal approach.
Patients who agreed with the informed consent
Key exclusion criteria
Patients who disagreed with the informed consent
Patients who are deemed inappropriate by the principal investigator or subinvestigator.
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | SUNAO |
| Middle name | |
| Last name | SHOJI |
Organization
Tokai University
Division name
Department of Urology
Zip code
259-1193
Address
Isehara 143, Shimokasuya, Kanagawa, Japan
TEL
0463-93-1121
sunashoj@mail.goo.ne.jp
Public contact
Name of contact person
| 1st name | SUNAO |
| Middle name | |
| Last name | SHOJI |
Organization
Tokai University
Division name
Department of Urology
Zip code
259-1193
Address
Shimokasuya 143, Isehara, Kanagawa, Japan
TEL
0463-93-1121
Homepage URL
sunashoj@mail.goo.ne.jp
Sponsor or person
Institute
Tokai University
Institute
Department
Personal name
Funding Source
Organization
Self funding
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
Institutional Review Board for Clinical Research, Tokai University
Address
Shimokasuya 143, Isehara, Kanagawa, Japan
Tel
0463-93-1121
sunashoj@gmail.com
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
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 03 | Month | 20 | 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
Open public recruiting
Date of protocol fixation
| 2022 | Year | 12 | Month | 13 | Day |
Date of IRB
| 2022 | Year | 12 | Month | 26 | Day |
Anticipated trial start date
| 2023 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 04 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 03 | Month | 19 | Day |
Last modified on
| 2023 | Year | 03 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000057673
