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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000036512
Receipt No. R000041598
Scientific Title Examination of the urethral position in the radiation therapy of the prostate cancer
Date of disclosure of the study information 2019/04/18
Last modified on 2019/04/15

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Basic information
Public title Examination of the urethral position in the radiation therapy of the prostate cancer
Acronym Examination of the urethral position in the radiation therapy of the prostate cancer
Scientific Title Examination of the urethral position in the radiation therapy of the prostate cancer
Scientific Title:Acronym Examination of the urethral position in the radiation therapy of the prostate cancer
Region
Japan

Condition
Condition Prostate cancer
Classification by specialty
Urology Radiology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the displacement of the urethra by what enables us to visualize on CT or MRI images in the radiation treatment to prostate cancer.
Basic objectives2 Bio-equivalence
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes The amount and the direction of the urethral displacement on the planning CT images for radiation treatment (RT-CT) compared with and without urethral catheter.
Key secondary outcomes When we divide the urethra into three segments (superior, median, and inferior), to identify the segments which show more urethral displacement.

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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 Patients with localized prostate cancer, and who take the RT-CT with a real-time tumor-tracking radiation therapy (RTRT) system.
Key exclusion criteria When we take the RT-CT, patents who did not permit or enable us to insert an urethral catheter or a guide-wire, or who had troubles such as missing the catheter or the guide-wire
Target sample size 163

Research contact person
Name of lead principal investigator
1st name Shinichi
Middle name
Last name Shimizu
Organization Faculty of Medicine, Hokkaido University
Division name Department of Radiation Medical Science and Engineering
Zip code 001-0015
Address Kita 15-jo Nishi 7-chome, Kita-ku, Sapporo-shi, Hokkaido.
TEL 011-706-5977
Email sshing@med.hokudai.ac.jp

Public contact
Name of contact person
1st name Yasuhiro
Middle name
Last name Dekura
Organization Graduate school of Medicine, Hokkaido University
Division name Department of Radiation Oncology
Zip code 001-0015
Address Kita 15-jo Nishi 7-chome, Kita-ku, Sapporo-shi, Hokkaido.
TEL 011-706-5977
Homepage URL
Email derideri.dekura@frontier.hokudai.ac.jp

Sponsor
Institute Hokkaido University Hospital
Institute
Department

Funding Source
Organization Japan Society for the Promotion of Science (JSPS)
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization Japana

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Hokkaido University Clinical Research Review Board
Address Kita 14-jo Nishi 5-chome, Kita-ku, Sapporo-shi, Hokkaido.
Tel 011-706-7636
Email crjimu@huhp.hokudai.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 北海道大学病院(北海道)

Other administrative information
Date of disclosure of the study information
2019 Year 04 Month 18 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 163
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 No longer recruiting
Date of protocol fixation
2011 Year 11 Month 30 Day
Date of IRB
2018 Year 03 Month 07 Day
Anticipated trial start date
2018 Year 03 Month 08 Day
Last follow-up date
2020 Year 03 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information One hundred sixty-three consecutive localized prostate cancer patients treated between Dec. 2011 and Jun. 2017 were included. All of the patients would be treated with a real-time tumor-tracking radiation therapy (RTRT) system.

Management information
Registered date
2019 Year 04 Month 15 Day
Last modified on
2019 Year 04 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041598

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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