UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022636 |
|---|---|
| Receipt number | R000026097 |
| Scientific Title | Clinical trials about the correlation of change and PSA of the MRI (DWI-ADC) after a treatment halfway point and the end of treatment radiotherapy for prostate cancer |
| Date of disclosure of the study information | 2016/06/07 |
| Last modified on | 2019/06/29 11:16:12 |
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Basic information
Public title
Clinical trials about the correlation of change and PSA of the MRI (DWI-ADC) after a treatment halfway point and the end of treatment radiotherapy for prostate cancer
Acronym
Correlation of change and PSA of the MRI after a treatment halfway point and the end of treatment radiotherapy for prostate cancer
Scientific Title
Clinical trials about the correlation of change and PSA of the MRI (DWI-ADC) after a treatment halfway point and the end of treatment radiotherapy for prostate cancer
Scientific Title:Acronym
Correlation of change and PSA of the MRI after a treatment halfway point and the end of treatment radiotherapy for prostate cancer
Region
| Japan |
Condition
Condition
prostate cancer
Classification by specialty
| Urology | Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Correlative of examines MRI-ADC and the value with the PSA test in radiotherapy for prostate cancer
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
A correlation is seen in MRI image findings and a value of the blood test PSA
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 50 | years-old | <= |
Age-upper limit
| 90 | years-old | > |
Gender
Male
Key inclusion criteria
Performance status is the patient of 0 or 1. The patients that a written consent was obtained.
Key exclusion criteria
Patient with no informed consent.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | tanaka |
| Middle name | |
| Last name | Osamu |
Organization
Gifu Municipal Hospital
Division name
Department of Radiation Oncology
Zip code
5008523
Address
7-1 kashima-cho Gifu Japan
TEL
058-251-1101
c.bluered@gmail.com
Public contact
Name of contact person
| 1st name | OSAMU |
| Middle name | |
| Last name | TANAKA |
Organization
Gifu Municipal Hospital
Division name
Department of Radiation Oncology
Zip code
5008523
Address
Gifu
TEL
+819076730893
Homepage URL
c.bluered@gmail.com
Sponsor or person
Institute
Gifu Municipal Hospital
Institute
Department
Personal name
Funding Source
Organization
self
Organization
Division
Category of Funding Organization
Local Government
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Asahi University
Address
3-23 Hashimoto-cho
Tel
+819076730893
c.bluered@gmail.com
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
| 2016 | Year | 06 | Month | 07 | 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
| 2016 | Year | 05 | Month | 17 | Day |
Date of IRB
| 2016 | Year | 05 | Month | 10 | Day |
Anticipated trial start date
| 2016 | Year | 06 | Month | 07 | Day |
Last follow-up date
| 2017 | Year | 03 | Month | 14 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
We observe a state of prostate cancer of the patients and a correlation with the blood test PSA using noninvasive MR imaging
Management information
Registered date
| 2016 | Year | 06 | Month | 07 | Day |
Last modified on
| 2019 | Year | 06 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026097
