UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057174 |
|---|---|
| Receipt number | R000065352 |
| Scientific Title | Ultra-hypofractionated proton therapy for prostate cancer |
| Date of disclosure of the study information | 2025/04/01 |
| Last modified on | 2025/02/28 16:01:59 |
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Basic information
Public title
Ultra-hypofractionated proton therapy for prostate cancer
Acronym
Ultra-hypofractionated proton therapy for prostate cancer
Scientific Title
Ultra-hypofractionated proton therapy for prostate cancer
Scientific Title:Acronym
Ultra-hypofractionated proton therapy for 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 ultra-hypofractionated proton therapy (PT) and conventionally fractionated PT for prostate cancer, focusing on toxicity.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Acute-subacute and late urinary toxicity (within 2 year)
Key secondary outcomes
PSA recurrence
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 over 20 years of age with localized prostate cancer (cT1-T3aN0M0)
2) Patients requesting spacer insertion and gold marker insertion.
3)Intermediate/high-risk group: patients who have been on hormone therapy for more than 6 months
4) Patients who can visit the hospital during PT.
5) Patients who have been informed about this study and have given written consent.
Key exclusion criteria
1) Patients with cT3b or higher
2) Patients with a history of pelvic surgery
3) Patients with previous pelvic radiotherapy
4) Patients with poor control of urination and defecation who are receiving medications.
5) Patients with active malignancy other than prostate cancer
6) Other patients deemed by the investigator to be incompatible with this study
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Sachika |
| Middle name | |
| Last name | Shiraishi |
Organization
Shonan kamakura general hospital
Division name
Radiation Oncology
Zip code
247-8533
Address
1370-1 Okamoto, Kamakura-City, Kanagawa
TEL
0467-46-1717
s-nogi@tokyo-med.ac.jp
Public contact
Name of contact person
| 1st name | Sachika |
| Middle name | |
| Last name | Shiraishi |
Organization
Shonan kamakura general hospital
Division name
Radiation Oncology
Zip code
247-8533
Address
1370-1 Okamoto, Kamakura-City, Kanagawa
TEL
0467-46-1717
Homepage URL
s-nogi@tokyo-med.ac.jp
Sponsor or person
Institute
Department of Radiation Oncology, Shonan Kamakura General Hospital, Kamakura, Japan;
Sachika Shiraishi
Institute
Department
Personal name
Funding Source
Organization
No Funding
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The Tokushukai Group Ethics Committee
Address
Tokyodo Chiyoda Bldg. 15F, 1-3-1, Kudan-minami, Chiyoda-ku, Tokyo 102-0074, Japan
Tel
03-3263-4801
ccts_kyoyu38@shonankamakura.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
湘南鎌倉総合病院（神奈川県）
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 04 | Month | 01 | 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
Preinitiation
Date of protocol fixation
| 2025 | Year | 02 | Month | 07 | Day |
Date of IRB
| 2025 | Year | 02 | Month | 12 | Day |
Anticipated trial start date
| 2025 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2029 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Checks at 3,6,9,12,18,and 24 months after completion of PT
Expanded prostate cancer index composite;EPI,International prostate symptom score;IPSS
Prostate specific antigen;PSA
Post-treatment status;alive or dead,PSA recurrence or not,treatment for recurrence,acute to subacute or late toxicity
Management information
Registered date
| 2025 | Year | 02 | Month | 28 | Day |
Last modified on
| 2025 | Year | 02 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065352
