UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043978 |
|---|---|
| Receipt number | R000050202 |
| Scientific Title | Establishment of a novel diagnosis and treatment system of prostate cancer for both early continence recovery and cancer control after radical prostatectomy. |
| Date of disclosure of the study information | 2021/08/01 |
| Last modified on | 2021/04/20 01:58:29 |
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Basic information
Public title
Establishment of a novel diagnosis and treatment system of prostate cancer for both early continence recovery and cancer control after radical prostatectomy.
Acronym
Establishment of a novel diagnosis and treatment system of prostate cancer for both early continence recovery and cancer control after radical prostatectomy.
Scientific Title
Establishment of a novel diagnosis and treatment system of prostate cancer for both early continence recovery and cancer control after radical prostatectomy.
Scientific Title:Acronym
Establishment of a novel diagnosis and treatment system of prostate cancer for both early continence recovery and cancer control after radical prostatectomy.
Region
| Japan |
Condition
Condition
prostate cancer
Classification by specialty
| Urology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To aim for both early continence recovery and cancer control after radical prostatectomy using MRI-US fusion target biopsy and dorsal vein complex preserving technique during robot-assisted radical prostatectomy.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1. Oncological outcomes
2. early continence recovery
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
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Robot-assisted radical prostatectomy for localized prostate cancer
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
1. Prostate cancer diagnosed by MRI-US fusion target biopsy and systematic 12-core biopsy.
2. Patients whose PSA level are under 20ng/mL.
3. Patients who are not diagnosed as extra prostatic extent by mpMRI.
4. Patients who are not detected more than Gleason score 3+3 in prostate apex.
5. Patients who are not ditected more than Gleason score 4+3 in biopsy specimens.
Key exclusion criteria
Gleason score 4+4
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Kent |
| Middle name | Kanao |
| Last name | Kanao |
Organization
Saitama Medical University International Medical Center
Division name
Uro-Oncology
Zip code
350-1298
Address
1397-1 Hidaka, Saitama, Japan 350-1298
TEL
042-984-4111
kanaok@saitama-med.ac.jp
Public contact
Name of contact person
| 1st name | Kent |
| Middle name | Kanao |
| Last name | Kanao |
Organization
Saitama Medical University International Medical Center
Division name
Uro-Oncology
Zip code
350-1298
Address
1397-1 Hidaka, Saitama, Japan 350-1298
TEL
042-984-4111
Homepage URL
kanaok@saitama-med.ac.jp
Sponsor or person
Institute
Saitama Medical University International Medical Center
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
Saitama Medical University International Medical Center
Address
1397-1 Hidaka, Saitama, Japan 350-1298
Tel
042-984-4111
kanaok@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
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 08 | 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 | 10 | Day |
Date of IRB
Anticipated trial start date
| 2021 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2025 | 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 | 04 | Month | 20 | Day |
Last modified on
| 2021 | Year | 04 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050202
