UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009823 |
|---|---|
| Receipt number | R000011494 |
| Scientific Title | Dynamic Contrast-Enhanced Magnetic Resonance Imaging Study for Biochemocal Failures after Radical Prostatectomy |
| Date of disclosure of the study information | 2013/01/21 |
| Last modified on | 2018/01/26 15:13:41 |
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Basic information
Public title
Dynamic Contrast-Enhanced Magnetic Resonance Imaging Study for Biochemocal Failures after Radical Prostatectomy
Acronym
DCE-MRI for BFRP
Scientific Title
Dynamic Contrast-Enhanced Magnetic Resonance Imaging Study for Biochemocal Failures after Radical Prostatectomy
Scientific Title:Acronym
DCE-MRI for BFRP
Region
| Japan |
Condition
Condition
Prostate cancer
Classification by specialty
| Urology | Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To detect recurrence with dynamic contrast-enhanced magnetic resonance imaging (DCE-MRI) and biopsy for prostate bed for patients with bichemical failure after radical prostatectomy. And to deliver salvage radiation therapy with dose-edcalated IMRT.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Validity of DCE-MRI for PSA failure
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
Prevention
Type of intervention
| Other |
Interventions/Control_1
To detect recurrence with 3-tesla dynamic contrast-enhanced magnetic resonance imaging (DCE-MRI) and biopsy for prostate bed for patients with bichemical failure after radical prostatectomy. And to deliver salvage radiation therapy. Especially for patients of whom recurrence is detected by DCE-MRI with acquired consent, dose-edcalated IMRT will be adapted.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male
Key inclusion criteria
Patients with pathologically proven prostate cancer who underwent radical prostatectomy and present biochemical failure after PSA nadir.
Key exclusion criteria
Patients who are at risk for MRI study, for local biopsy of prostate bed, who cannot make their own decision, or patients who are considered inadequate by attendant physicians.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kenshiro Shiraishi |
Organization
The University of Tokyo Hospital
Division name
Department of Radiology
Zip code
Address
7-3-1, Hongo, Bunkyo-ku, Tokyo, Japan
TEL
0338155411
kshiraishi-tky@umin.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kenshiro Shiraishi |
Organization
The University of Tokyo Hospital
Division name
Department of Radiology
Zip code
Address
7-3-1, Hongo, Bunkyo-ku, Tokyo, Japan
TEL
0338155411
Homepage URL
kshiraishi-tky@umin.ac.jp
Sponsor or person
Institute
The University of Tokyo Hospital
Institute
Department
Personal name
Funding Source
Organization
Departmen of Radiology, The University of Tokyo Hospital
Organization
Division
Category of Funding Organization
Self funding
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
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 01 | Month | 21 | 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
| 2012 | Year | 07 | Month | 26 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 07 | Month | 26 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2013 | Year | 01 | Month | 21 | Day |
Last modified on
| 2018 | Year | 01 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011494
