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Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000020199
Receipt No. R000023329
Official scientific title of the study Hypofractionated proton beam therapy for localized prostate cancer
Date of disclosure of the study information 2015/12/15
Last modified on 2015/12/15

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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

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
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

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) 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

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 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 Preinitiation
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
2015 Year 12 Month 15 Day


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


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