UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028630 |
|---|---|
| Receipt number | 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 | 2023/08/14 09:42:03 |
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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 | Hiroshi |
| Middle name | |
| Last name | Tsuji |
Organization
QST Hospital, National Institutes for Quantum Science and Technology
Division name
Treatment division
Zip code
263-8555
Address
4-9-1 Anagawa, Inage Ward, Chiba City
TEL
043-251-2111
tsuji.hiroshi@qst.go.jp
Public contact
Name of contact person
| 1st name | Goro |
| Middle name | |
| Last name | Kasuya |
Organization
QST Hospital, National Institutes for Quantum Science and Technology
Division name
Treatment division
Zip code
263-8555
Address
4-9-1 Anagawa, Inage Ward, Chiba City
TEL
043-251-2111
Homepage URL
kasuya.goro@qst.go.jp
Sponsor or person
Institute
QST Hospital, National Institutes for Quantum Science and Technology
Treatment division
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education
National Institutes for Quantum 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
National Institutes for Quantum Science and Technology Certified Review Board
Address
4-9-1 Anag awa, Inag e-ku, Chiba-shi, Chiba
Tel
0 4 3 -2 0 6 -4 7 0 6
helsinki@qst.go.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
国立研究開発法人量子科学技術研究開発機構 QST病院
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
Terminated
Date of protocol fixation
| 2017 | Year | 08 | Month | 09 | Day |
Date of IRB
| 2019 | Year | 07 | Month | 31 | Day |
Anticipated trial start date
| 2017 | Year | 08 | Month | 24 | Day |
Last follow-up date
| 2025 | Year | 08 | 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
| 2017 | Year | 08 | Month | 10 | Day |
Last modified on
| 2023 | Year | 08 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032765
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