UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045064 |
|---|---|
| Receipt number | R000051482 |
| Scientific Title | A Prospective Clinical Trial of Proton Radiotherapy with 12 fractions for Patients with Prostate Cancer |
| Date of disclosure of the study information | 2021/08/16 |
| Last modified on | 2023/02/06 14:13:26 |
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Basic information
Public title
A Prospective Clinical Trial of Proton Radiotherapy with 12 fractions for Patients with Prostate Cancer
Acronym
Proton Radiotherapy with 12 fractions for Prostate Cancer
Scientific Title
A Prospective Clinical Trial of Proton Radiotherapy with 12 fractions for Patients with Prostate Cancer
Scientific Title:Acronym
Proton Radiotherapy with 12 fractions for Prostate Cancer
Region
| Japan |
Condition
Condition
Prostate cancer
Classification by specialty
| Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the safety and efficacy of the proton radiotherapy with 12 fractions for prostate cancer in Narita memorial proton center
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
Early-phase (< 90 days after start of irradiation) bladder/urinary adverse event rate (>Grade 2)
Key secondary outcomes
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
51.6GyRBE in 12 fractions with a fractional dose of 4.3GyRBE (4 times per week)
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) Histologically diagnosed primary prostate adenocarcinoma
2) Either clinical stage of T1-T3b and N0M0, in accordance with UICC (2017)
3) ECOG Performance status is 0, 1 or 2
4) Twenty years old of age at registration or more
5) Patient without active double cancer or severe basic disease
6) Patient who can keep his posture during irradiation
7) Technically being able to be irradiated
8) Written informed consent
Key exclusion criteria
1) Patient without tissue specimen of biopsy
2) Patient with past history of radiotherapy for the targeted lesion
3) Patient with past history of surgery for the target lesion
4) Patient with active and intractable infection in the targeted lesion
5) Patient who is administrated more than two anticoagulant drugs
6) Inflammatory bowel diseases or after the surgery of rectal cancer
7) Patient who cannot be put the metal marker or spacer
8) Patient with severe disease
9) Judged as inappropriate to participation by investigators
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Yuta |
| Middle name | |
| Last name | Shibamoto |
Organization
Narita memorial proton center
Division name
Department of proton
Zip code
441-8021
Address
Shirakawa cho 78, Toyohashi, Aichi
TEL
0532-33-0033
yshiba@med.nagoya-cu.ac.jp
Public contact
Name of contact person
| 1st name | Takeshi |
| Middle name | |
| Last name | Yanagi |
Organization
Narita memorial proton center
Division name
Department of proton
Zip code
441-8021
Address
Shirakawa cho 78, Toyohashi, Aichi
TEL
0532-33-0033
Homepage URL
tyana116@meiyokai.or.jp
Sponsor or person
Institute
Narita Memorial Proton Center
Institute
Department
Personal name
Funding Source
Organization
None
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
Narita memorial hospital ethics committee
Address
Haneihonmachi 134, Toyohashi, Aichi
Tel
0532-31-2167
suzukik@meiyokai.or.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
| 2021 | Year | 08 | Month | 16 | 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
Enrolling by invitation
Date of protocol fixation
| 2021 | Year | 07 | Month | 08 | Day |
Date of IRB
| 2021 | Year | 07 | Month | 08 | Day |
Anticipated trial start date
| 2021 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2028 | 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
| 2021 | Year | 08 | Month | 04 | Day |
Last modified on
| 2023 | Year | 02 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051482
