UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020354 |
|---|---|
| Receipt number | R000023507 |
| Scientific Title | A Prospective Observational Study on the Carbon Ion Therapy for Localized and Locally Advanced Prostate Cancer |
| Date of disclosure of the study information | 2015/12/28 |
| Last modified on | 2023/12/25 14:19:07 |
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Basic information
Public title
A Prospective Observational Study on the Carbon Ion Therapy for Localized and Locally Advanced Prostate Cancer
Acronym
A Prospective Observational Study on the Carbon Ion Therapy for Advanced Prostate Cancer (iROCK-PR01 Study)
Scientific Title
A Prospective Observational Study on the Carbon Ion Therapy for Localized and Locally Advanced Prostate Cancer
Scientific Title:Acronym
A Prospective Observational Study on the Carbon Ion Therapy for Advanced Prostate Cancer (iROCK-PR01 Study)
Region
| Japan |
Condition
Condition
Localized or locally advanced prostate cancer
Classification by specialty
| Urology | Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To confirm the safety and efficacy of the Carbon Ion Therapy for T1-T3N0M0 localized or locally advanced prostate cancer in Kanagawa cancer center.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Phase II
Assessment
Primary outcomes
Incidence of late-phase rectal adverse event with CTCAE Grade 2 or more
Key secondary outcomes
1) Incidence of early and late adverse events
2) 5-year biochemical and clinical recurrence
3) 5-year overall survival
4) Local control rate
5) ECOG Performance Status (PS)
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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 proven primary prostate adenocarcinoma
2) cT1c,T2a,T2b,T2c,T3a,T3bN0M0
(2009, UICC 7th)
3) Performance status is 0, 1 or 2
4) Under 20 years old of age at registration
5) Untreated patient in prostate cancer, excluding neoadjuvant endocrine therapy.
6) Patients are informed for diagnosis of prostate cancer and independently agree with this study on carbon-ion radiotherapy
Key exclusion criteria
1) Past history of radiotherapy in the irradiation lesion concerned
2) Multiple active malignancies
3) Medically or psychologically inappropriate status for this study judged by physicians
Target sample size
12
Research contact person
Name of lead principal investigator
| 1st name | Hiroyuki |
| Middle name | |
| Last name | Katoh |
Organization
Kanagawa Cancer Center, Kanagawa Prefectural Hospital Organization
Division name
Department of Carbon-ion Radiotherapy
Zip code
241-8515
Address
2-3-2 Nakao, Asahi-ku, Yokohama, Kanagawa Prefecture
TEL
045-520-2222
hkatoh@kcch.jp
Public contact
Name of contact person
| 1st name | Hiroyuki |
| Middle name | |
| Last name | Katoh |
Organization
Kanagawa Cancer Center, Kanagawa Prefectural Hospital Organization
Division name
Ion-beam Radiation Oncology Center
Zip code
241-8515
Address
2-3-2 Nakao, Asahi-ku, Yokohama, Kanagawa Prefecture
TEL
045-520-2222
Homepage URL
hkatoh@kcch.jp
Sponsor or person
Institute
Kanagawa Cancer Center,
Kanagawa Prefectural Hospital Organization
Institute
Department
Personal name
Funding Source
Organization
Kanagawa Prefectual Hospital Organization
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
None
Name of secondary funder(s)
None
IRB Contact (For public release)
Organization
Kanagawa Cancer Center IRB
Address
2-3-2, Nakao, Asahi-ku, YOKOHAMA, Kanagawa Pref.
Tel
0455202222
clinical_trials@kcch.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
神奈川県立病院機構
神奈川県立がんセンター
Kanagawa Cancer Center,
Kanagawa Prefectural Hospital Organization
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 12 | Month | 28 | 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
11
Results
This study confirmed safety and efficacy comparable to those reported from prior facilities.
Results date posted
| 2023 | Year | 12 | Month | 21 | Day |
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
Completed
Date of protocol fixation
| 2015 | Year | 10 | Month | 29 | Day |
Date of IRB
| 2015 | Year | 10 | Month | 29 | Day |
Anticipated trial start date
| 2015 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2026 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2026 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2027 | Year | 03 | Month | 31 | Day |
Other
Other related information
Study Design: Single-arm prospective observational study
Subject Recruitment: Patients who visits Kanagawa Cancer Center during the registration period -i.e., from November to December 2015, and who fulfilling the inclusion and exclusion criteria
Management information
Registered date
| 2015 | Year | 12 | Month | 25 | Day |
Last modified on
| 2023 | Year | 12 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023507
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
