UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050538 |
|---|---|
| Receipt number | R000057555 |
| Scientific Title | Radiotherapy with hyperthermia for patients with high-risk prostate cancer; a multicenter prospective observational study |
| Date of disclosure of the study information | 2023/03/08 |
| Last modified on | 2024/02/10 09:31:10 |
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Basic information
Public title
Radiotherapy with hyperthermia for patients with high-risk prostate cancer; a multicenter prospective observational study
Acronym
JSTM-PROS01HR
Scientific Title
Radiotherapy with hyperthermia for patients with high-risk prostate cancer; a multicenter prospective observational study
Scientific Title:Acronym
JSTM-PROS01HR
Region
| Japan |
Condition
Condition
Prostate cancer
Classification by specialty
| Urology | Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To determine treatment efficacy, adverse events, and heating feasibility in hyperthermia combined radiotherapy for high-risk prostate cancer through a multicenter prospective registry of patient data.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
5-year biochemical recurrence-free survival rate
Key secondary outcomes
3/5/8-year overall/cause-specific /clinical recurrence-free survival rate, Adverse event rate, Transitions in the IPSS and QOL scores
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) Patients diagnosed with high-risk prostate cancer
2) Patients undergoing radiotherapy and hyperthermia
3) Patients who are 20 years of age or older at the time of enrollment
4) Patients with an ECOG Performance Status (PS) of 0 to 2
5) Patients expected to survive more than 3 months
Key exclusion criteria
1) Patients with multiple cancers (simultaneous multiple cancers or iatrogenic multiple cancers with a disease-free interval of 5 years or less).However, intraepithelial cancer, lesions equivalent to intramucosal cancer, and skin cancer are not included in overlapping cancers.
2) Patients who have a history of irradiation (re-irradiation) at the same site as the current irradiation.
3) Patients who will be treated with three-dimensional source body irradiation
4) Patients who will not receive concomitant endocrine therapy
5) Patients who are scheduled to receive concomitant small source radiation therapy
6) Patients who are judged by the principal investigator to be inappropriate for enrollment in this study.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Makoto |
| Middle name | |
| Last name | Ito |
Organization
Aichi Medical University Hospital
Division name
Radiology
Zip code
480-1103
Address
1-1 Yazako-Karimata, Nagakute, Aichi
TEL
0561-62-3311
itou.makoto.292@mail.aichi-med-u.ac.jp
Public contact
Name of contact person
| 1st name | Makoto |
| Middle name | |
| Last name | Ito |
Organization
Aichi Medical University Hospital
Division name
Radiology
Zip code
480-1103
Address
1-1 Yazako-Karimata, Nagakute, Aichi
TEL
0561-62-3311
Homepage URL
itou.makoto.292@mail.aichi-med-u.ac.jp
Sponsor or person
Institute
Aichi Medical University
Institute
Department
Personal name
Makoto Ito
Funding Source
Organization
Self-funding
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
Aichi Medical University /Faculty of Medicine Ethics Committee
Address
1-1 Yazako-Karimata, Nagakute, Aichi
Tel
0561-62-3311
amu_ethics@aichi-med-u.ac.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
愛知医科大学病院(愛知県)/ Aichi Medical University Hospital(Aichi)
群馬大学数理データ科学教育研究センター (群馬県)/ Gunma University Center for Mathematics and Data Science (Gunma)
産業医科大学病院(福岡県)/ University of Occupational and Environmental Health(Fukuoka)
弘前大学医学部附属病院 (青森県)/ Hirosaki University Hospital (Aomori)
名古屋市立大学病院(愛知県)/ Nagoya City University Hospital (Aichi)
久留米大学病院(福岡県)/ Kurume University Hospital(Fukuoka)
総合大雄会病院(愛知県)/ Daiyukai General Hospital(Aichi)
厚生連高岡病院(富山県)/ Kouseiren Takaoka Hospital(Toyama)
総合南東北病院／南東北がん陽子線治療センター(福島県)/Southern Tohoku General Hospital/Southern Tohoku Proton Therapy Center
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 03 | Month | 08 | 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
| 2022 | Year | 12 | Month | 26 | Day |
Date of IRB
| 2023 | Year | 02 | Month | 06 | Day |
Anticipated trial start date
| 2023 | Year | 03 | Month | 08 | Day |
Last follow-up date
| 2026 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2023 | Year | 03 | Month | 08 | Day |
Last modified on
| 2024 | Year | 02 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000057555
