UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A phase II study on the carbon-ion radiotherapy for T1c-T3N0M0 localized prostate cancer
Title of the study (Brief title)	Carbon-ion radiotherapy for localized prostate cancer (iROCK-1501PR)
Region	Japan

Condition
Condition	Localized prostate cancer
Classification by specialty	Surgery in general Urology Radiology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the safety and efficacy of the carbon ion radiotherapy for localized prostate cancer with clinical stage of T1c-T3N0M0 in Kanagawa Cancer Center
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Explanatory
Developmental phase	Phase II

Assessment
Primary outcomes	Biochemical progression-free survival at 5 years
Key secondary outcomes	1) Overall survival 2) Disease-specific survival 3) Event-free survival 4) Early and late-phase adverse event rate

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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	Device,equipment
Interventions/Control_1	Carbon-ion radiation therapy A total of 51.6GyE consisting of 12 fractions; once a day 4.3 GyE, 6-8 times for 2 weeks
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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	Not applicable
Gender	Male
Key inclusion criteria	1) Histologically confirmed primary prostate adenocarcinoma 2) cT1c,T2a,T2b,T2c,T3a,T3b,N0M0, in accordance with UICC 7th (2009) 3) ECOG Performance status is 0, 1 or 2 4) Over 20 of age at registration 5) Untreated patient for prostate cancer, excluding Neoadjuvant endocrine therapy 6) Patients are informed for diagnosis of prostate cancer and independently agree with this study on carbon-ion radiotherapy
Key exclusion criteria	1) Patient with past history of radiotherapy for the targeted lesion 2) Patient with castration-resistant prostate cancer 3) Patient with active double cancer 4) Patients with active and intractable infection in the targeted lesion. 5) Patient with metal devices in the lesion 6) Other medical or psychological condition which is unsuitable for carbon-ion therapy
Target sample size	145

Research contact person
Name of lead principal investigator	Dr. Takuma Nomiya
Organization	Kanagawa Cancer Center, Kanagawa Prefectural Hospital Organization
Division name	Department of Carbon-ion Radiotherapy
Address	2-3-2 Nakao, Asahi-ku, Yokohama, Kanagawa Prefecture
TEL	045-520-2222
Email	tnomiya@kcch.jp

Public contact
Name of contact person	Dr. Takuma Nomiya
Organization	Kanagawa Cancer Center, Kanagawa Prefectural Hospital Organization
Division name	Department of Carbon-ion Radiotherapy
Address	2-3-2 Nakao, Asahi-ku, Yokohama, Kanagawa Prefecture
TEL	045-520-2222
Homepage URL
Email	tnomiya@kcch.jp

Sponsor
Institute	Kanagawa Cancer Center, Kanagawa Prefectural Hospital Organization
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization	Kanagawa Cancer Center, Kanagawa Prefectural Hospital Organization
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor	None
Name of secondary funｄer(s)	None

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	2016 Year 02 Month 03 Day

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2016 Year 01 Month 05 Day
Anticipated trial start date	2016 Year 01 Month 15 Day
Last follow-up date	2027 Year 06 Month 28 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2016 Year 02 Month 02 Day
Last modified on	2017 Year 06 Month 20 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024063

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