UMIN-CTR Clinical Trial

Basic information
Public title	Real-time tumor-tracking proton beam therapy for prostate cancer
Acronym	Real-time tumor-tracking proton beam therapy for prostate cancer
Scientific Title	Real-time tumor-tracking proton beam therapy for prostate cancer
Scientific Title:Acronym	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	1st name Hiroki Middle name Last name Shirato
Organization	Hokkaido University Graduate School of Medicine
Division name	Department of Radiation Medicine
Zip code	060-8638
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	1st name Shinichi Middle name Last name Shimizu
Organization	Hokkaido University Graduate School of Medicine
Division name	Department of Radiation Medicine
Zip code	060-8638
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)

IRB Contact (For public release)
Organization	Hokkaido University Hospital Clinical Research and Medical Innovation Center
Address	North 14 West 5, Kita-Ku, Sapporo, Hokkaido, Japan
Tel	+81-11-706-7636
Email	crjimu@huhp.hokudai.ac.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	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

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled	45
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	2015 Year 01 Month 14 Day
Date of IRB	2015 Year 02 Month 20 Day
Anticipated trial start date	2015 Year 02 Month 25 Day
Last follow-up date	2020 Year 02 Month 29 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2015 Year 02 Month 18 Day
Last modified on	2020 Year 08 Month 25 Day

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