UMIN-CTR Clinical Trial

Basic information
Public title	Phase I/II clinical trial of hypofractionated image-guided proton therapy for prostate cancer
Acronym	Phase I/II clinical trial of hypofractionated image-guided proton therapy for prostate cancer
Scientific Title	Phase I/II clinical trial of hypofractionated image-guided proton therapy for prostate cancer
Scientific Title:Acronym	Phase I/II clinical trial of hypofractionated image-guided proton therapy for prostate cancer
Region	Japan

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

Objectives
Narrative objectives1	To evaluate the efficacy and safety of hypofractionated image-guided proton therapy for prostate cancer
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The ratio of grade 2 or more acute genitourinary toxicity
Key secondary outcomes	5-year OS, bRFS, cRFS, bRF, cRF, Grade 2 or more late toxicity, QOL change

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Other
Interventions/Control_1	image-guided proton therapy
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 and Female
Key inclusion criteria	1) histologically-confirmed prostate cancer 2) T1-T3bN0M0 3) ECOG-PS: 0-2 4) age: more than 20 years old 5) serious underlying disease or other cancers 6) capable of maintaining their position during irradiation 7) technically capable of proton therapy 8) written informed consent
Key exclusion criteria	1)pathological specimen is not available to confirm the diagnosis 2)previous radiotherapy around the lesion 3)surgery for prostate cancer is performed prior to registration 4)active and uncontrolled infection 5)two or more anticoagulants and antiplatelets 6)bowel disease such as ulcerative colitis or postoperative rectal cancer 7)patients who cannot or refuse gold markers and Space OAR 8)serious complication 9)cases in which the doctor is judged inappropriate for medical or other reasons
Target sample size	300

Research contact person
Name of lead principal investigator	1st name Hiroyuki Middle name Last name Ogino
Organization	Nagoya City West Medical Center,Nagoya Proton Therapy Center
Division name	Radiation oncology
Zip code	462-8508
Address	1-1-1 Hirate-cho, Kita-ku, Nagoya-city, Aichi-prefecture
TEL	052-991-8577
Email	oginogio@gmail.com

Public contact
Name of contact person	1st name Hiromitsu Middle name Last name Iwata
Organization	Nagoya City West Medical Center,Nagoya Proton Therapy Center
Division name	Radiation oncology
Zip code	462-8508
Address	1-1-1 Hirate-cho, Kita-ku, Nagoya-city, Aichi-prefecture
TEL	052-991-8577
Homepage URL
Email	h-iwa-ncu@nifty.com

Sponsor
Institute	Nagoya City West Medical Center
Institute
Department

Funding Source
Organization	Takeda Science Foundation
Organization
Division
Category of Funding Organization	Non profit foundation
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Clinical Study Committees of the Nagoya City Hospital
Address	1-2-23 Wakamizu, Chikusa-ku, Nagoya-city, Aichi-prefecture
Tel	052-721-7171
Email	rinsho1@higashi-hosp.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 01 Month 06 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
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	Preinitiation
Date of protocol fixation	2019 Year 08 Month 07 Day
Date of IRB
Anticipated trial start date	2020 Year 01 Month 06 Day
Last follow-up date	2026 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2019 Year 10 Month 11 Day
Last modified on	2019 Year 10 Month 11 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043633

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name

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