UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038279 |
|---|---|
| Receipt number | R000043633 |
| Scientific Title | Phase I/II clinical trial of hypofractionated image-guided proton therapy for prostate cancer |
| Date of disclosure of the study information | 2020/01/06 |
| Last modified on | 2025/04/15 16:58:45 |
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Basic information
Public title
Phase I/II clinical trial of hypofractionated image-guided proton therapy for prostate cancer
Acronym
Phase I/II clinical trial of hypofractionated image-guided proton therapy for prostate cancer
Scientific Title
Phase I/II clinical trial of hypofractionated image-guided proton therapy for prostate cancer
Scientific Title:Acronym
Phase I/II clinical trial of hypofractionated image-guided proton therapy for prostate cancer
Region
| Japan |
Condition
Condition
localized prostate cancer
Classification by specialty
| Urology | Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy and safety of hypofractionated image-guided proton therapy for prostate cancer
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The ratio of grade 2 or more acute genitourinary toxicity
Key secondary outcomes
5-year OS, bRFS, cRFS, bRF, cRF, Grade 2 or more late toxicity, QOL change
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
image-guided proton therapy
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 and Female
Key inclusion criteria
1) histologically-confirmed prostate cancer
2) T1-T3bN0M0
3) ECOG-PS: 0-2
4) age: more than 20 years old
5) serious underlying disease or other cancers
6) capable of maintaining their position during irradiation
7) technically capable of proton therapy
8) written informed consent
Key exclusion criteria
1)pathological specimen is not available to confirm the diagnosis
2)previous radiotherapy around the lesion
3)surgery for prostate cancer is performed prior to registration
4)active and uncontrolled infection
5)two or more anticoagulants and antiplatelets
6)bowel disease such as ulcerative colitis or postoperative rectal cancer
7)patients who cannot or refuse gold markers and Space OAR
8)serious complication
9)cases in which the doctor is judged inappropriate for medical or other reasons
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Hiroyuki |
| Middle name | |
| Last name | Ogino |
Organization
Nagoya City University West Medical Center,Nagoya Proton Therapy Center
Division name
Radiation oncology
Zip code
462-8508
Address
1-1-1 Hirate-cho, Kita-ku, Nagoya-city, Aichi-prefecture
TEL
052-991-8577
oginogio@gmail.com
Public contact
Name of contact person
| 1st name | Hiromitsu |
| Middle name | |
| Last name | Iwata |
Organization
Nagoya City University West Medical Center,Nagoya Proton Therapy Center
Division name
Radiation oncology
Zip code
462-8508
Address
1-1-1 Hirate-cho, Kita-ku, Nagoya-city, Aichi-prefecture
TEL
052-991-8577
Homepage URL
h-iwa-ncu@nifty.com
Sponsor or person
Institute
Nagoya City University West Medical Center
Institute
Department
Personal name
Funding Source
Organization
Takeda Science Foundation
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Clinical Study Committees of the Nagoya City Hospital
Address
1-2-23 Wakamizu, Chikusa-ku, Nagoya-city, Aichi-prefecture
Tel
052-721-7171
rinsho1@higashi-hosp.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
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 01 | Month | 06 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
300
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
No longer recruiting
Date of protocol fixation
| 2019 | Year | 08 | Month | 07 | Day |
Date of IRB
| 2019 | Year | 09 | Month | 04 | Day |
Anticipated trial start date
| 2020 | Year | 01 | Month | 06 | Day |
Last follow-up date
| 2026 | Year | 12 | 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
| 2019 | Year | 10 | Month | 11 | Day |
Last modified on
| 2025 | Year | 04 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043633
