UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019029 |
|---|---|
| Receipt number | R000021692 |
| Scientific Title | The utility of 11C-choline PET/CT in prostate patients of PSA failure |
| Date of disclosure of the study information | 2015/10/01 |
| Last modified on | 2022/02/13 10:04:31 |
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Basic information
Public title
The utility of 11C-choline PET/CT in prostate patients of PSA failure
Acronym
11C-choline PET/CT in PSA failure
Scientific Title
The utility of 11C-choline PET/CT in prostate patients of PSA failure
Scientific Title:Acronym
11C-choline PET/CT in PSA failure
Region
| Japan |
Condition
Condition
Prostate Cancer
Classification by specialty
| Urology | Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To prospectively compare the diagnostic aacuracy and clinical impact for restaging prostate cancer in patients with PSA failure between conventional imaging modalities (pelvis MRI, chest/abdomen CT, bone scintigraphy).
Basic objectives2
Others
Basic objectives -Others
To find the true usefulness of 11C-choline PET/CT for restaging prostate cancer after treatmen.t
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
To compare diagnostic accuracy (ROC analysis, sensitivity, specificity, and accuracy) for diagnosing lymph node recurrence between 11C-choline PET/CT and chest/abdomen CT.
Key secondary outcomes
To compare diagnostic accuracy (ROC analysis, sensitivity, specificity, and accuracy) for diagnosing local recurrence and distant metastasis and clinical impact between 11C-choline PET/CT and chest/abdomen CT.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Maneuver |
Interventions/Control_1
11C-choline PET/CT, pelvic MRI, chest/abdomen CT, bone scintigraphy
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
| 100 | years-old | >= |
Gender
Male
Key inclusion criteria
*The patients that the urology department chief physician judged an examination for 11C-Colin PET/CT to be necessary.
*The patients who show PSA failure after the treatments.
*The patients who underwent or will undergo pelvic MRI, chest/abdomen CT, bone scintigraphy.
*The patients in good condition.
*The patients who can understand study contents, and a written agreement is provided
Key exclusion criteria
*The patients who cannot keep face up position because of sharp pain in succession for around 30 minutes.
*The patients with the extreme claustrophobia.
*The patients whom the ADL which I become independent and can inspect is not kept.
*The patients who a study person in charge is judged to be inappropriate.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Koichiro |
| Middle name | |
| Last name | Yamakado |
Organization
Hyogo College of Medicine
Division name
Radiology
Zip code
663-8501
Address
Mukogawa-cho 1-1, Nishinomiya, Hyogo
TEL
0798-45-6362
hirota-s@hyo-med.ac.jp
Public contact
Name of contact person
| 1st name | Kazuhiro |
| Middle name | |
| Last name | Kitajima |
Organization
Hyogo College of Medicine
Division name
Nuclear Medicine and PET Center
Zip code
663-8501
Address
Mukogawa-cho 1-1, Nishinomiya, Hyogo
TEL
0798-45-6883
Homepage URL
ka-kitajima@hyo-med.ac.jp
Sponsor or person
Institute
Radiology, Hyogo College of Medicine
Institute
Department
Personal name
Funding Source
Organization
Hyogo-prefecture health Foundation
Shinryoku-kai
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Radiology, Hyogo College of Medicine
Address
1-1 Mukogawa-cho 1-1, Nishinomiya, Hyogo 663-8501
Tel
0798-45-6883
kazu10041976@yahoo.co.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
兵庫医科大学病院（兵庫県）
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 10 | Month | 01 | Day |
Related information
URL releasing protocol
http://www.hyo-med.ac.jp/department/radt/
Publication of results
Unpublished
Result
URL related to results and publications
Acta Med Okayama
Number of participants that the trial has enrolled
20
Results
Twenty Japanese prostate cancer patients underwent 11C-choline and FDG PET/CT. The sensitivity/specificity/accuracy/AUC for choline-PET for diagnosing local lesions were 90.9%/100%/95.0%/1.0, whereas those for FDG-PET were 45.5%/100%/75.0%/0.773. Those for choline-PET for node metastasis were 88.9%/100%/95.0%/0.944, and those for FDG-PET were 44.4%/100%/75.0%/0.722. Those for choline-PET for bone metastasis were 84.6%/100%/90.0%/0.951, and those for FDG-PET were 76.9%/100%/85.0%/0.962.
Results date posted
| 2022 | Year | 02 | Month | 13 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Patients scheduled to receive choline PET/CT
Participant flow
From the Urology staff
Adverse events
None
Outcome measures
Diagnostic performance of detecting local prostate cancer, lymph node metastasis, and bone metastasis
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Open public recruiting
Date of protocol fixation
| 2015 | Year | 10 | Month | 01 | Day |
Date of IRB
| 2015 | Year | 08 | Month | 31 | Day |
Anticipated trial start date
| 2015 | Year | 10 | Month | 07 | Day |
Last follow-up date
| 2025 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2025 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2025 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2025 | Year | 12 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2015 | Year | 09 | Month | 15 | Day |
Last modified on
| 2022 | Year | 02 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021692
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