UMIN-CTR Clinical Trial

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	Completed
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	2020 Year 06 Month 23 Day

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