UMIN-CTR Clinical Trial

Basic information
Public title	The comparison of the treatment results after 51.6 Gy (RBE) in 12 fractionated carbon-ion radiotherapy after long follow up duration -Passive technique vs Scanning technique-
Acronym	Long follow up 51.6Gy(RBE)in 12 fr. for prostate cancer
Scientific Title	The comparison of the treatment results after 51.6 Gy (RBE) in 12 fractionated carbon-ion radiotherapy after long follow up duration -Passive technique vs Scanning technique-
Scientific Title:Acronym	Long follow up 51.6Gy(RBE)in 12 fr. for 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 clinical outcomes with long term follow up of the patients with prostate cancer treated with 51.6 (RBE)/12fr, and especially, to compare the beam techniques:passive and scanning beam.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Biochemical relapse-free survival
Key secondary outcomes

Base
Study type	Others,meta-analysis etc

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	20 years-old <=
Age-upper limit	Not applicable
Gender	Male
Key inclusion criteria	Localized prostate cancer cases who received carbon-ion radiotherapy of 51.6Gy(RBE)in 12 fractions in protcol 1002 (July 2010-October 2011) or protocol 9904-4 (April 2013-Febrary 2014)
Key exclusion criteria	Other than the above.
Target sample size	260

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	0432063306
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	0432063306
Homepage URL
Email	kasuya.goro@qst.go.jp

Sponsor
Institute	National institutes for Quantum and Radiological Science and Technology
Institute
Department

Funding Source
Organization	National institutes for Quantum and Radiological Science and Technology
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	National Institutes for Quantum and Radiological Science and Technology Certified Review Board
Address	4-9-1 Anagawa, Inage-ku, Chiba-shi, Chiba
Tel	043-206-4706
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

Other administrative information
Date of disclosure of the study information	2020 Year 09 Month 25 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	260
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	2020 Year 08 Month 18 Day
Date of IRB	2020 Year 09 Month 10 Day
Anticipated trial start date	2020 Year 09 Month 10 Day
Last follow-up date	2022 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Retrospective study

Management information
Registered date	2020 Year 09 Month 24 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=R000047795