UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020199 |
|---|---|
| Receipt number | R000023329 |
| Scientific Title | Hypofractionated proton beam therapy for localized prostate cancer |
| Date of disclosure of the study information | 2015/12/15 |
| Last modified on | 2017/06/30 16:43:58 |
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Basic information
Public title
Hypofractionated proton beam therapy for localized prostate cancer
Acronym
Hypofractionated proton beam therapy for localized prostate cancer
Scientific Title
Hypofractionated proton beam therapy for localized prostate cancer
Scientific Title:Acronym
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
| 1st name | |
| Middle name | |
| Last name | Katsunori Tauchi |
Organization
Aizawa hospital
Division name
Comprehensive Cancer Center
Zip code
Address
2-5-1 Honjou Matsumoto-City, Nagano 390-8510 JAPAN
TEL
+81-263-33-8600
ai.65718@ai-hosp.or.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masayuki Araya |
Organization
Aizawa hospital
Division name
Proton therapy center
Zip code
Address
2-5-1 Honjou Matsumoto-City, Nagano 390-8510 JAPAN
TEL
+81-263-33-8600
Homepage URL
ai.65718@ai-hosp.or.jp
Sponsor or person
Institute
Aizawa hospital
Institute
Department
Personal name
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)
IRB Contact (For public release)
Organization
Address
Tel
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 |
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
Terminated
Date of protocol fixation
| 2015 | Year | 12 | Month | 14 | Day |
Date of IRB
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
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023329
