UMIN-CTR Clinical Trial

Basic information
Public title	DVH analyses at urination between before and after by using 4DCT for the patients with prostate cancer
Acronym	DVH analyses at urination between before and after by using 4DCT for the patients with prostate cancer
Scientific Title	DVH analyses at urination between before and after by using 4DCT for the patients with prostate cancer
Scientific Title:Acronym	DVH analyses at urination between before and after by using 4DCT for the patients with prostate cancer
Region	Japan

Condition
Condition	prostate cancer
Classification by specialty	Radiology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To clarify the affection due to the difference of DVH between before and after urination for the patients with prostate cancer
Basic objectives2	Others
Basic objectives -Others	The change in the location of each organ
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The dose to bladder and rectum and planning target volume according to DVH analyses
Key secondary outcomes

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	1)The patients who are treated with carbon-ion radiotherapy 2) Patients who hope to participate in this study
Key exclusion criteria	1) having abnormal by examination after concent 2) Patients who have difficulty performing CT imaging 3) Patient after femoral head replacement 4)Those who are judged by the doctor to be ineligible for the study.
Target sample size	20

Research contact person
Name of lead principal investigator	1st name Goro Middle name Last name Kasuya
Organization	QST hospital
Division name	treatment section
Zip code	263-8555
Address	4-9-1 anagawa inage-ku chiba
TEL	04320633306
Email	kasuya.goro@qst.go.jp

Public contact
Name of contact person	1st name Goro Middle name Last name Kasuya
Organization	QST hospital
Division name	treatment section
Zip code	263-8555
Address	4-9-1 anagawa inage-ku chiba
TEL	04320633306
Homepage URL
Email	kasuya.goro@qst.go.jp

Sponsor
Institute	QST hospital
Institute
Department

Funding Source
Organization	Ministry of education
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	National Institutes for Quantum and Radiological Science and Technology Certified Review Board
Address	4-9-1 Anagawa, Inage-ku, Chiba-shi, Chiba
Tel	0 4 3 -2 0 6 -4 7 0 6
Email	helsinki@qst.go.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	QST病院

Other administrative information
Date of disclosure of the study information	2020 Year 02 Month 10 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	20
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	2019 Year 12 Month 20 Day
Date of IRB	2020 Year 01 Month 31 Day
Anticipated trial start date	2020 Year 02 Month 11 Day
Last follow-up date	2021 Year 08 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Prospective observational study to analyze and compare DVH by taking two treatment planning CTs during bladder collapse and one-hour urine collection

Management information
Registered date	2020 Year 02 Month 07 Day
Last modified on	2021 Year 08 Month 10 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044952