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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000016573
Receipt No. R000018975
Official scientific title of the study Real-time tumor-tracking proton beam therapy for prostate cancer
Date of disclosure of the study information 2015/02/26
Last modified on 2017/02/20

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Basic information
Official scientific title of the study Real-time tumor-tracking proton beam therapy for prostate cancer
Title of the study (Brief title) Real-time tumor-tracking proton beam therapy 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 confirm the safety and efficacy of real-time tumor-tracking proton beam therapy for prostate cancer
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase I,II

Assessment
Primary outcomes Incidence of early adverse effects within 90 days after real-time tumor-tracking proton beam therapy
Key secondary outcomes Relapse free survival, incidence of adverse effect of Grade 3 or higher and cost-effectiveness at 18 months, incidence of dropout and migration of Au markers during treatment period

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 Real-time tumor-tracking proton beam 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
Key inclusion criteria 1) Pathologically proven adenocarcinoma of the prostate
2) ECOG-PS 0-2
3) Age 20-yrs old or over at the time of consent form is obtained
4) Well informed and documented consent from the patient
Key exclusion criteria 1) Pathologically proven non-adenocarcinoma or mixed type adenocarcinoma of the prostate
2) Clinically obvious lymph node or distant metastasis
3) With active other cancers
4) With severe uncontrolled diabetes
5) With severe heart disease, or some serious complications, i.e., SLE, Scleroderma
6) With an inflammatory bowel syndrome, i.e., Crohn's disease, ulcerative colitis
7) Previous surgical treatment or High-intensity focused ultrasound (HIFU) for prostate
8) Previous chemotherapy for prostate cancer before enrollment
9) Previous surgery to pelvis, except for appendectomy
10) Previous radiotherapy to pelvis
11) With implantable cardioverter defibrillator or permanent pacemaker
12) Allergic to radiation
13) Considered that participation in this trial is difficult because of psychiatric symptoms or psychosis
14) Cannot be held rest for about 30 minutes
15) Cannot be implanted Au marker in the prostate
16) Weight over 135 kg
17) Unsuitable for enrollment judged by principal investigator
Target sample size 45

Research contact person
Name of lead principal investigator Hiroki Shirato
Organization Hokkaido University Graduate School of Medicine
Division name Department of Radiation Medicine
Address North 15 West 7, Kita-Ku, Sapporo, Hokkaido, Japan
TEL +81-11-706-5977
Email shirato@med.hokudai.ac.jp

Public contact
Name of contact person Shinichi Shimizu
Organization Hokkaido University Graduate School of Medicine
Division name Department of Radiation Medicine
Address North 15 West 7, Kita-Ku, Sapporo, Hokkaido, Japan
TEL +81-11-706-5977
Homepage URL
Email sshing@med.hokudai.ac.jp

Sponsor
Institute Department of Radiation Medicine, Hokkaido University Graduate School of Medicine
Institute
Department

Funding Source
Organization Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization Government offices of other countries
Nationality of Funding Organization Japan

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 北海道大学病院(北海道)

Other administrative information
Date of disclosure of the study information
2015 Year 02 Month 26 Day

Progress
Recruitment status Open public recruiting
Date of protocol fixation
2015 Year 01 Month 14 Day
Anticipated trial start date
2015 Year 02 Month 25 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 02 Month 18 Day
Last modified on
2017 Year 02 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018975

Research Plan
Registered date Registrant File name

Research case data specifications
Registered date Registrant File name

Research case data
Registered date Registrant File name


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