UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041610 |
|---|---|
| Receipt number | R000047497 |
| Scientific Title | Clinical efficacy and safety of prostatic periapical triangle block for transperineal cognitive fusion prostate biopsy and rectal hydrogel spacer injection. |
| Date of disclosure of the study information | 2020/08/31 |
| Last modified on | 2024/03/03 11:02:35 |
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Basic information
Public title
Clinical efficacy and safety of prostatic periapical triangle block for transperineal cognitive fusion prostate biopsy and rectal hydrogel spacer injection.
Acronym
Clinical efficacy and safety of prostatic periapical triangle block for transperineal cognitive fusion prostate biopsy and rectal hydrogel spacer injection.
Scientific Title
Clinical efficacy and safety of prostatic periapical triangle block for transperineal cognitive fusion prostate biopsy and rectal hydrogel spacer injection.
Scientific Title:Acronym
Clinical efficacy and safety of prostatic periapical triangle block for transperineal cognitive fusion prostate biopsy and rectal hydrogel spacer injection.
Region
| Japan |
Condition
Condition
prostate cancer
Classification by specialty
| Urology | Anesthesiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate efficacy and safety of periapical triangle block and supplemental local anesthesia for cognitive fusion transperinial prostate biopsy and rectal hydrogel spacer injection.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Visual Analogue Scale (VAS)
Key secondary outcomes
Operation time
Complications
Base
Study type
Interventional
Study design
Basic design
Factorial
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
4
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
1-1. Only PAT block for transperineal cognitive fusion prostate biopsy
Interventions/Control_2
1-2. PAT block, percutaneous lidocaine and prilocaine patch and intrarectal lidocaine gel for transperineal cognitive fusion prostate biopsy
Interventions/Control_3
2-1. Only PAT block for rectal hydrogel spacer injection
Interventions/Control_4
2-2. PAT block, percutaneous lidocaine and prilocaine patch and intrarectal lidocaine gel for rectal hydrogel spacer injection
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. 20 years old or greater, PSA > 4 ng/ml, positive multi parametric MRI, and men who need a prostate biopsy
2. 20 years old or greater, histopathologically confirmed prostate cancer, and men who need radiotherapy (IMRT, brachytherapy)
Key exclusion criteria
Patients who have difficulty communicating due to mental disorders, patients with a history of perineal/rectal surgery and difficulty in transrectal ultrasound insertion, and patient with rectal invasion of prostate cancer
Target sample size
190
Research contact person
Name of lead principal investigator
| 1st name | Hideki |
| Middle name | |
| Last name | Takeshita |
Organization
Saitama Medical Center, Saitama Medical University
Division name
Department of Urology
Zip code
3508550
Address
1981 Kamoda, Kawagoe, Saitama, Japan
TEL
81492283673
takeuro@saitama-med.ac.jp
Public contact
Name of contact person
| 1st name | Hideki |
| Middle name | |
| Last name | Takeshita |
Organization
Saitama Medical Center, Saitama Medical University
Division name
Department of Urology
Zip code
3508550
Address
1981 Kamoda, Kawagoe, Saitama, Japan
TEL
81492283673
Homepage URL
takeuro@saitama-med.ac.jp
Sponsor or person
Institute
Department of Urology, Saitama Medical Center, Saitama Medical University
Institute
Department
Personal name
Funding Source
Organization
Department of Urology, Saitama Medical Center, Saitama Medical University
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
Saitama Medical Center Ethics Comittee, Saitama Medical University
Address
Kamoda 1981, Kawagoe, Saitama, Japan
Tel
81492283902
smcrinri@saitama-med.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
埼玉医科大学総合医療センター（埼玉県）
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 08 | Month | 31 | 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
0
Results
exam canceled
Results date posted
| 2024 | Year | 03 | Month | 03 | Day |
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
Terminated
Date of protocol fixation
| 2020 | Year | 08 | Month | 31 | Day |
Date of IRB
| 2020 | Year | 10 | Month | 01 | Day |
Anticipated trial start date
| 2020 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 12 | 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
| 2020 | Year | 08 | Month | 30 | Day |
Last modified on
| 2024 | Year | 03 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047497
