UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034190 |
|---|---|
| Receipt number | R000038979 |
| Scientific Title | Clinical utility of PET/CT with 18F-FSU-880 for recurrent prostate cancer |
| Date of disclosure of the study information | 2018/10/01 |
| Last modified on | 2022/09/21 09:58:14 |
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Basic information
Public title
Clinical utility of PET/CT with 18F-FSU-880 for recurrent prostate cancer
Acronym
PSMA PET for recurrent prostate cancer
Scientific Title
Clinical utility of PET/CT with 18F-FSU-880 for recurrent prostate cancer
Scientific Title:Acronym
PSMA PET for recurrent prostate cancer
Region
| Japan |
Condition
Condition
prostate cancer
Classification by specialty
| Urology | Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate the clinical utility of FSU-880-PET/CT in patients with known or suspected recurrent prostate cancer
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
presence or absence of abnormal uptake of FSU-880
Key secondary outcomes
Time course of uptake and/or tumor-to-background ratio in a lesion
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Medicine |
Interventions/Control_1
Collect PET/CT data after intravenous administration of [18F]FSU-880 (approximately 185MBq)that is produced by automated synthetic device.
PET/CT data collection is finished in 1 day.
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
| 20 | years-old | <= |
Age-upper limit
| 85 | years-old | >= |
Gender
Male
Key inclusion criteria
1.Patients who are suspected of having recurrence due to their increased PSA or diagnostic imaging after surgery for prostate cancer
2. Patients who are determined to be appropriate for this study by participating physicians according to the results of physical examination and blood/urine/physiological function tests.
3. Patients who give us written informed consent
Key exclusion criteria
1. Patients having severe communication problem.
2. Patients with severe general condition.
3. Patients having severe renal dysfunction (eGFR<39mL/min/1.73m3) expected to affect the distribution of [18F]FSU-880..
4. Patients to whom participating physicians judged to be inappropriate for this study.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Yuji |
| Middle name | |
| Last name | Nakamoto |
Organization
Kyoto University Hospital
Division name
Department of Radiology
Zip code
606-8507
Address
54 Kawahara-cho, Shogoin, Sakyo-ku, Kyoto 606-8507, Japan
TEL
075-751-3760
ynakamo1@kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | Yoichi |
| Middle name | |
| Last name | Shimizu |
Organization
Kyoto University Hospital
Division name
Department of Radiology
Zip code
606-8507
Address
54 Kawahara-cho, Shogoin, Sakyo-ku, Kyoto 606-8507, Japan
TEL
075-751-3760
Homepage URL
yoichis@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Kyoto University Hospital
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kyoto University Graduate School and Faculty of Medicine, Ethics Committee
Address
Yoshidakonoe, Sakyo-ku, Kyoto
Tel
075-753-4680
ethcom@kuhp.kyoto-u.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
| 2018 | Year | 10 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
74
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
| 2018 | Year | 09 | Month | 18 | Day |
Date of IRB
| 2018 | Year | 12 | Month | 27 | Day |
Anticipated trial start date
| 2019 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 09 | 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
| 2018 | Year | 09 | Month | 18 | Day |
Last modified on
| 2022 | Year | 09 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038979
