UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016573 |
|---|---|
| Receipt number | R000018975 |
| Scientific Title | Real-time tumor-tracking proton beam therapy for prostate cancer |
| Date of disclosure of the study information | 2015/02/26 |
| Last modified on | 2020/08/25 23:25:43 |
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Basic information
Public title
Real-time tumor-tracking proton beam therapy for prostate cancer
Acronym
Real-time tumor-tracking proton beam therapy for prostate cancer
Scientific Title
Real-time tumor-tracking proton beam therapy for prostate cancer
Scientific Title:Acronym
Real-time tumor-tracking proton beam 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 confirm the safety and efficacy of real-time tumor-tracking proton beam therapy for prostate cancer
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase I,II
Assessment
Primary outcomes
Incidence of early adverse effects within 90 days after real-time tumor-tracking proton beam therapy
Key secondary outcomes
Relapse free survival, incidence of adverse effect of Grade 3 or higher and cost-effectiveness at 18 months, incidence of dropout and migration of Au markers during treatment period
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
Real-time tumor-tracking proton beam 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
Key inclusion criteria
1) Pathologically proven adenocarcinoma of the prostate
2) ECOG-PS 0-2
3) Age 20-yrs old or over at the time of consent form is obtained
4) Well informed and documented consent from the patient
Key exclusion criteria
1) Pathologically proven non-adenocarcinoma or mixed type adenocarcinoma of the prostate
2) Clinically obvious lymph node or distant metastasis
3) With active other cancers
4) With severe uncontrolled diabetes
5) With severe heart disease, or some serious complications, i.e., SLE, Scleroderma
6) With an inflammatory bowel syndrome, i.e., Crohn's disease, ulcerative colitis
7) Previous surgical treatment or High-intensity focused ultrasound (HIFU) for prostate
8) Previous chemotherapy for prostate cancer before enrollment
9) Previous surgery to pelvis, except for appendectomy
10) Previous radiotherapy to pelvis
11) With implantable cardioverter defibrillator or permanent pacemaker
12) Allergic to radiation
13) Considered that participation in this trial is difficult because of psychiatric symptoms or psychosis
14) Cannot be held rest for about 30 minutes
15) Cannot be implanted Au marker in the prostate
16) Weight over 135 kg
17) Unsuitable for enrollment judged by principal investigator
Target sample size
45
Research contact person
Name of lead principal investigator
| 1st name | Hiroki |
| Middle name | |
| Last name | Shirato |
Organization
Hokkaido University Graduate School of Medicine
Division name
Department of Radiation Medicine
Zip code
060-8638
Address
North 15 West 7, Kita-Ku, Sapporo, Hokkaido, Japan
TEL
+81-11-706-5977
shirato@med.hokudai.ac.jp
Public contact
Name of contact person
| 1st name | Shinichi |
| Middle name | |
| Last name | Shimizu |
Organization
Hokkaido University Graduate School of Medicine
Division name
Department of Radiation Medicine
Zip code
060-8638
Address
North 15 West 7, Kita-Ku, Sapporo, Hokkaido, Japan
TEL
+81-11-706-5977
Homepage URL
sshing@med.hokudai.ac.jp
Sponsor or person
Institute
Department of Radiation Medicine, Hokkaido University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Government offices of other countries
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Hokkaido University Hospital Clinical Research and Medical Innovation Center
Address
North 14 West 5, Kita-Ku, Sapporo, Hokkaido, Japan
Tel
+81-11-706-7636
crjimu@huhp.hokudai.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
北海道大学病院(北海道)
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 02 | Month | 26 | 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
45
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
Completed
Date of protocol fixation
| 2015 | Year | 01 | Month | 14 | Day |
Date of IRB
| 2015 | Year | 02 | Month | 20 | Day |
Anticipated trial start date
| 2015 | Year | 02 | Month | 25 | Day |
Last follow-up date
| 2020 | Year | 02 | Month | 29 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 02 | Month | 18 | Day |
Last modified on
| 2020 | Year | 08 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018975
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| Registered date | File name |
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