UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Hypofractionated proton beam therapy for localized prostate cancer
Title of the study (Brief title)	Hypofractionated proton beam therapy for localized prostate cancer
Region	Japan

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

Objectives
Narrative objectives1	To confirm the feasibility and efficacy of hypofractionated proton beam therapy for localized prostate cancer
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Phase II

Assessment
Primary outcomes	5-year rate of Grade 2 or worse late toxicity
Key secondary outcomes	Acute and late toxicity rate, biochemical relapse-free rate, overall survival rate, cause-specific survival rate, and clinical relapse-free survival rate at 5 years

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	Maneuver
Interventions/Control_1	67.5GyE in 25 fractions with a fractional dose of 2.7Gy
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	1) Pathologically proven adenocarcinoma of the prostate 2) cT1c-T4N0M0(UICC 7th) Prostate cancer 3) ECOG-PS 0-2 4) Age 20-yrs old or over at the time of consent form is obtained 5) Well informed and documented consent from the patient
Key exclusion criteria	1) With active other cancers 2) With severe uncontrolled diabetes 3) With severe heart disease, or some serious complications, i.e., SLE, Scleroderma, interstitial pneumonia 4) Allergic to radiation 5) Previous surgical treatment for prostate disease before enrollment 6) Previous chemotherapy (except holmonal therapy)for prostate cancer before enrollment 7) Previous radiotherapy to pelvis 8) With implantable cardioverter defibrillator or permanent pacemaker 9) Considered that participation in this trial is difficult because of psychiatric symptoms or psychosis 10) Cannot be held rest for about 60 minutes 11) Cannot be implanted Au marker in the prostate 12) Unsuitable for enrollment judged by principal investigator
Target sample size	120

Research contact person
Name of lead principal investigator	Katsunori Tauchi
Organization	Aizawa hospital
Division name	Comprehensive Cancer Center
Address	2-5-1 Honjou Matsumoto-City, Nagano 390-8510 JAPAN
TEL	+81-263-33-8600
Email	ai.65718@ai-hosp.or.jp

Public contact
Name of contact person	Masayuki Araya
Organization	Aizawa hospital
Division name	Proton therapy center
Address	2-5-1 Honjou Matsumoto-City, Nagano 390-8510 JAPAN
TEL	+81-263-33-8600
Homepage URL
Email	ai.65718@ai-hosp.or.jp

Sponsor
Institute	Aizawa hospital
Institute
Department

Funding Source
Organization	Aizawa hospital
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

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

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	相澤病院（長野県）

Other administrative information
Date of disclosure of the study information	2015 Year 12 Month 15 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2015 Year 12 Month 14 Day
Anticipated trial start date	2015 Year 12 Month 15 Day
Last follow-up date
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	2015 Year 12 Month 15 Day
Last modified on	2017 Year 06 Month 30 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000023329