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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000015447
Receipt No. R000017959
Scientific Title Investigation of Robot-assisted Laparoscopic radical Prostatectomy (RALP) with limited lymphadenectomy for the patients with low/ intermediate risk prostate cancer
Date of disclosure of the study information 2014/11/01
Last modified on 2014/10/16

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Basic information
Public title Investigation of Robot-assisted Laparoscopic radical Prostatectomy (RALP) with limited lymphadenectomy for the patients with low/ intermediate risk prostate cancer
Acronym Investigation of RALP for low/ intermediate risk prostate cancer
Scientific Title Investigation of Robot-assisted Laparoscopic radical Prostatectomy (RALP) with limited lymphadenectomy for the patients with low/ intermediate risk prostate cancer
Scientific Title:Acronym Investigation of RALP for low/ intermediate risk 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
Middle name
Last name Atsushi Takenaka
Organization Tottori University Faculty of Medicine
Division name Division of Urology, Department of Surgery
Zip code
Address 86 Nishi-cho, Yonago, Tottori
TEL 0859-38-6607
Email atake@med.tottori-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Shuichi Morizane
Organization Tottori University Faculty of Medicine
Division name Division of Urology, Department of Surgery
Zip code
Address 86 Nishi-cho, Yonago, Tottori
TEL 0859-38-6607
Homepage URL
Email morizane@med.tottori-u.ac.jp

Sponsor
Institute Tottori University Faculty of Medicine
Institute
Department

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
Address
Tel
Email

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
Anticipated trial start date
2014 Year 11 Month 01 Day
Last follow-up date
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
2014 Year 10 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017959

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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