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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000028630
Receipt No. R000032765
Scientific Title A Phase I/II trial of focal carbon-ion radiotherapy using 4 fractions for the patients with local recurrence prostate cancer after radiotherapy
Date of disclosure of the study information 2017/08/29
Last modified on 2017/08/28

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Basic information
Public title A Phase I/II trial of focal carbon-ion radiotherapy using 4 fractions for the patients with local recurrence prostate cancer after radiotherapy
Acronym Carbon-ion radiotherapy for local recurrence prostate cancer
Scientific Title A Phase I/II trial of focal carbon-ion radiotherapy using 4 fractions for the patients with local recurrence prostate cancer after radiotherapy
Scientific Title:Acronym Carbon-ion radiotherapy for local recurrence prostate cancer
Region
Japan

Condition
Condition Prostate cancer
Classification by specialty
Urology Radiology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the safety and efficacy of focal carbon-ion radiotherapy using 4 fractions for the patients with local recurrence prostate cancer after radiotherapy
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase I,II

Assessment
Primary outcomes Acute and late adverse effect
Key secondary outcomes Biochemical relapse free survival, overall survival, Clinical relapse free survival, cancer specific survival, dose-volume evaluation, QOL evaluation

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 Carbon-ion radiotherapy of 40Gy(RBE)in 4 fraction within 1 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

Not applicable
Age-upper limit

Not applicable
Gender Male
Key inclusion criteria 1) Local recurrence biopsy proven prostate cancer after radical radiotherapy.
2) rT2a-T2bN0M0 according to MRI, CT and bone scintigram (visible lesion in MRI).
3) PSA < 8.0 ng/ml before biopsy proven local recurrence after biochemical relapse.
4) PSA doubling time > 6 months.
5) Teststeron value within 30 days before starting this treatment > within normal lower limit.
6) Performance Status (ECOG) of 0-1.
7) Approved by document.
Key exclusion criteria 1) Other salvage therapy has been performed except for the case with positive local recurrence by biopsy after discontinuance of hormonal therapy
2) Presence of biopsy proven separate lesions except for visible lesion in MRI.
3) Having at least one factor of GS>9, T3b and PSA > 40 ng/ml before initial radical radiotherapy.
4) occuring Grade 3 or more severe adverse effect after initial radical radiotherapy.
5) Ineligible dose constraint of risk organs
6) Considered to be castration resistant prostate cancer
7) Presence of active double cancer
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tsuji Hiroshi
Organization Hospital of the National Institute of Radiological Sciences, National Institutes for Quantum and Radiological Science and Technology
Division name Treatment division
Zip code
Address 4-9-1 Anagawa, Inage Ward, Chiba City
TEL 043-251-2111
Email tsuji.hiroshi@qst.go.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kasuya Goro
Organization Hospital of the National Institute of Radiological Sciences, National Institutes for Quantum and Rad
Division name Treatment division
Zip code
Address 4-9-1 Anagawa, Inage Ward, Chiba City
TEL 043-251-2111
Homepage URL
Email kasuya.goro@qst.go.jp

Sponsor
Institute Hospital of the National Institute of Radiological Sciences, National Institutes for Quantum and Radiological Science and Technology

Treatment division
Institute
Department

Funding Source
Organization Ministry of Education

Hospital of the National Institute of Radiological Sciences, National Institutes for Quantum and Radiological Science and Technology
Organization
Division
Category of Funding Organization Government offices of other countries
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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 国立研究開発法人量子科学技術研究開発機構放射線医学総合研究所

Other administrative information
Date of disclosure of the study information
2017 Year 08 Month 29 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 Open public recruiting
Date of protocol fixation
2017 Year 08 Month 09 Day
Date of IRB
Anticipated trial start date
2017 Year 08 Month 24 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
2017 Year 08 Month 10 Day
Last modified on
2017 Year 08 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032765

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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