UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000007293
Receipt number R000008598
Scientific Title Robot assisted radical prostatectomy
Date of disclosure of the study information 2012/02/14
Last modified on 2013/01/10 16:02:32

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Basic information

Public title

Robot assisted radical prostatectomy

Acronym

RARP

Scientific Title

Robot assisted radical prostatectomy

Scientific Title:Acronym

RARP

Region

Japan


Condition

Condition

localized prostate cancer

Classification by specialty

Urology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

The aim of study is to estimate the safety and efficacy of robot assisted radical prostatectomy

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Primary outcomes are operating time, bleeding volume, and the duration of urethral catheterisation.

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

Other

Interventions/Control_1

prostatectomy

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


Not applicable

Gender

Male

Key inclusion criteria

localized prostate cancer

Key exclusion criteria

previous radiological treatment for prostate cancer
previous HIFU treatment for prostate cancer
previous rectal cancer treatment
mental disorder unappropriate for this study
the others decided unsuitable by physicians

Target sample size

10


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Tetsuya Fujimura

Organization

Graduate School of Medicine, The University of Tokyo

Division name

Department of Urology

Zip code


Address

7-3-1, Hongo, Bunkyo-ku

TEL


Email



Public contact

Name of contact person

1st name
Middle name
Last name

Organization

Graduate School of Medicine, The University of Tokyo

Division name

Department of Urology

Zip code


Address


TEL


Homepage URL

http://www.cc.h.u-tokyo.ac.jp/mulins/index.html

Email



Sponsor or person

Institute

The University of Tokyo

Institute

Department

Personal name



Funding Source

Organization

The University of Tokyo

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


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

2012 Year 02 Month 14 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

Completed

Date of protocol fixation

2011 Year 07 Month 12 Day

Date of IRB


Anticipated trial start date

2011 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

2012 Year 02 Month 14 Day

Last modified on

2013 Year 01 Month 10 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008598


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name