UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015447 |
|---|---|
| Receipt number | R000017959 |
| Scientific Title | Investigation of Robot-assisted Laparoscopic radical Prostatectomy (RARP) for the patients with prostate cancer |
| Date of disclosure of the study information | 2014/11/01 |
| Last modified on | 2024/10/23 16:35:23 |
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Basic information
Public title
Investigation of Robot-assisted Laparoscopic radical Prostatectomy (RARP) for the patients with prostate cancer
Acronym
Investigation of RALP for prostate cancer
Scientific Title
Investigation of Robot-assisted Laparoscopic radical Prostatectomy (RARP) for the patients with prostate cancer
Scientific Title:Acronym
Investigation of RALP for prostate cancer
Region
| Japan |
Condition
Condition
Prostate Cancer
Classification by specialty
| Urology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
We evaluate the efficiency of robot-assisted laparoscopic radical prostatectomy for the patients with low/ intermediate prostate cancer.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
We evaluate the positive margin rate, continence rate, biochemical recurrence rate after operation.
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
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment | Maneuver |
Interventions/Control_1
We perform the operation using the surgical robot for 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
| Not applicable |
Age-upper limit
| 80 | years-old | >= |
Gender
Male
Key inclusion criteria
localized prostate cancer
low risk group, intermediate risk group
Key exclusion criteria
severe glaucoma
severe cerebrovascular disease
severe cardiopulmonary insufficiency
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | Atsushi |
| Middle name | |
| Last name | Takenaka |
Organization
Tottori University Faculty of Medicine
Division name
Division of Urology, Department of Surgery
Zip code
683-8503
Address
86 Nishi-cho, Yonago, Tottori
TEL
0859-38-6607
atake@tottori-u.ac.jp
Public contact
Name of contact person
| 1st name | Atsushi |
| Middle name | |
| Last name | Takenaka |
Organization
Tottori University Faculty of Medicine
Division name
Division of Urology, Department of Surgery
Zip code
683-8503
Address
86 Nishi-cho, Yonago, Tottori
TEL
0859-38-6607
Homepage URL
atake@tottori-u.ac.jp
Sponsor or person
Institute
Tottori University Faculty of Medicine
Institute
Department
Personal name
Funding Source
Organization
Tottori University Faculty of Medicine
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
Tottori University Hospital Institutional Review Board
Address
36-1 Nishi-cho, Yonago, Tottori
Tel
0859-38-6946
crsc@ml.med.tottori-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
| 2014 | Year | 11 | 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
Open public recruiting
Date of protocol fixation
| 2014 | Year | 11 | Month | 01 | Day |
Date of IRB
| 2014 | Year | 10 | Month | 17 | Day |
Anticipated trial start date
| 2014 | Year | 11 | 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
| 2014 | Year | 10 | Month | 16 | Day |
Last modified on
| 2024 | Year | 10 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017959
