UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011078 |
|---|---|
| Receipt number | R000012892 |
| Scientific Title | Clinical study about the position verification using gold marker in the external irradiation combined I-125 brachytherapy for localized prostate cancer |
| Date of disclosure of the study information | 2013/06/30 |
| Last modified on | 2015/01/04 21:16:02 |
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Basic information
Public title
Clinical study about the position verification using gold marker in the external irradiation combined I-125 brachytherapy for localized prostate cancer
Acronym
Clinical study about the position verification using gold marker in the external irradiation combined I-125 brachytherapy for localized prostate cancer
Scientific Title
Clinical study about the position verification using gold marker in the external irradiation combined I-125 brachytherapy for localized prostate cancer
Scientific Title:Acronym
Clinical study about the position verification using gold marker in the external irradiation combined I-125 brachytherapy for localized prostate cancer
Region
| Japan |
Condition
Condition
Prostate cancer
Classification by specialty
| Urology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the accuracy of the position verification by linear gold marker in the external irradiation combined I-125 brachytherapy for patients with localized prostate cancer.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
The relative position error between the position coordinate and the reference CT image of the prostate as an index of the linear gold marker
Key secondary outcomes
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
Linear gold marker is buried in the connective tissue both side of the prostate at seed implantation. CT imaging is acquired just after seed implantation. One month after seed implantation, the planning CT for external irradiation is imaged and is considered as a reference. External irradiation starts about one month after seed implantation. During the external irradiation, CT imaging is acquired once a week (five times in total).
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
| 35 | years-old | <= |
Age-upper limit
| 100 | years-old | > |
Gender
Male
Key inclusion criteria
1) Patients with intermediate/high risk group of localized prostate cancer to satisfy PSA>=10ng/ml or Gleason score>=7 or more than 34% positive biopsy core rate
2) Written informed consent must be obtained from patient
Key exclusion criteria
1) Patients less than 5 years life expectancy
2) Patients with distant metastases
3) Patients with gold allergy
4) Patients whom radiation therapy is contraindicated
5) Patients with bleeding tendency (including anticoagulant therapy)
6) Patients with ascites, pleural effusion
7) Parients suspeted with skin, pleura, peritoneum infection
8) Parients suspeted with abscess, vascular disease
9) Patients who can not be ensured a safe puncture route
10) Patients who can not be transfused
11) Patients whom target site is confusing
12) Patients who are judged inappropriate for the clinical trial by doctors
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tomoya Kaneda |
Organization
National Hospital Organization Saitama Hosipital
Division name
radiology
Zip code
Address
2-1, Suwa, Wako-shi, Saitama
TEL
048-462-1101
tomoya_k54@yahoo.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tomoya Kaneda |
Organization
National Hospital Organization Saitama Hosipital
Division name
Radiology
Zip code
Address
2-1, Suwa, Wako-shi, Saitama
TEL
048-462-1101
Homepage URL
tomoya_k54@yahoo.co.jp
Sponsor or person
Institute
National Hospital Organization Saitama Hosipital
Institute
Department
Personal name
Funding Source
Organization
National Hospital Organization Saitama Hosipital
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
Address
Tel
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
国立病院機構埼玉病院（埼玉県）
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 06 | Month | 30 | 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
Completed
Date of protocol fixation
| 2013 | Year | 06 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2014 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2013 | Year | 06 | Month | 30 | Day |
Last modified on
| 2015 | Year | 01 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012892
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