UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006612 |
|---|---|
| Receipt number | R000007344 |
| Scientific Title | To evaluate efficacy of image-guided intensity modulated radiotherapy using fiducial gold markers for localized advanced prostate cancer |
| Date of disclosure of the study information | 2011/11/01 |
| Last modified on | 2023/04/12 17:11:20 |
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Basic information
Public title
To evaluate efficacy of image-guided intensity modulated radiotherapy using fiducial gold markers for localized advanced prostate cancer
Acronym
To evaluate efficacy of image-guided IMRT using fiducial gold markers for prostate cancer
Scientific Title
To evaluate efficacy of image-guided intensity modulated radiotherapy using fiducial gold markers for localized advanced prostate cancer
Scientific Title:Acronym
To evaluate efficacy of image-guided IMRT using fiducial gold markers 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 efficacy of image-guided intensity modulated radiotherapy of 76-80Gy in 38-40 fractions using fiducial gold markers for localized advanced prostate cancer
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Biochemical relapse free survival
Cause-specific survival
Overall survival
Toxicity
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 | Maneuver |
Interventions/Control_1
Patients are treated with image-guided IMRT (76-80Gy/38-40fx.) using fiducial gold markers in the prostate.
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
| 40 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male
Key inclusion criteria
1) High-risk prostate cancer with cT1-3bN0M0 confirmed by histological diagnosis and MRI or bone scintigraphy
2) Patient should receive MRI examination before treatment.
3) ECOG PS 0-1
4) Patients must sign informed consent form prior to registration
Key exclusion criteria
1) Prior pelvic radiotherapy
2) Small cell carcinoma
3) cT4, exist of metastasis
4) Prior prostatectomy
5) Concurrent invasive cancers or collagen disease
6) PSA failure following hormonal therapy
7) If the attending physician judges the case inappropriate.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Ken |
| Middle name | |
| Last name | Takeda |
Organization
Health Sciences, Tohoku University Graduate School of Medicine
Division name
Department of Therapeutic Radiology
Zip code
980-8575
Address
2-1, Seiryomachi, Aobaku, Senddaishi, 980-8575, Japan
TEL
022-717-7909
ken.takeda.a3@tohoku.ac.jp
Public contact
Name of contact person
| 1st name | Ken |
| Middle name | |
| Last name | Takeda |
Organization
Health Sciences, Tohoku University Graduate School of Medicine
Division name
Department of Therapeutic Radiology
Zip code
980-8575
Address
2-1, Seiryomachi, Aobaku, Sendaishi,980-8574, Japan
TEL
022-717-7909
Homepage URL
ken.takeda.a3@tohoku.ac.jp
Sponsor or person
Institute
Tohoku University
Institute
Department
Personal name
Funding Source
Organization
Tohoku University
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
Tohoku University Graduate School of Medicine Ethics Committee
Address
1-1 Seiryo-cho, Aoba-ku, Sendai
Tel
022-717-8007
med-kenkyo@bureau.tohoku.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
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 11 | 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
Completed
Date of protocol fixation
| 2011 | Year | 08 | Month | 01 | Day |
Date of IRB
| 2011 | Year | 11 | Month | 18 | Day |
Anticipated trial start date
| 2011 | Year | 11 | Month | 18 | Day |
Last follow-up date
| 2016 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2011 | Year | 10 | Month | 25 | Day |
Last modified on
| 2023 | Year | 04 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007344
