UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037697 |
|---|---|
| Receipt number | R000042995 |
| Scientific Title | Diagnostic Performance of PET Imaging for Prostate Specific Membrane Antigen (PSMA) |
| Date of disclosure of the study information | 2019/09/01 |
| Last modified on | 2023/02/25 22:17:27 |
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Basic information
Public title
Diagnostic Performance of PET Imaging for Prostate Specific Membrane Antigen (PSMA)
Acronym
Diagnostic Performance of PSMA-PET
Scientific Title
Diagnostic Performance of PET Imaging for Prostate Specific Membrane Antigen (PSMA)
Scientific Title:Acronym
Diagnostic Performance of PSMA-PET
Region
| Japan |
Condition
Condition
Prostate cancer
Classification by specialty
| Urology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Patients with prostate cancer undergo PET/CT scan after injection of 18F-PSMA-1007, whose lesions are compared with those of conventional imaging techniques (CT / bone scintigraphy etc.). As to whether malignant or not, the clinical course including transition of PSA value (tumor markers for prostate cancer) and/or pathological findings of primary/metastatic lesion is evaluated.
Basic objectives2
Others
Basic objectives -Others
To elucidate clinical state of prostate cancer patient, and to diagnose prostate cancer with high-precision accuracy
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1) PSMA-PET findings compared with conventional imaging findings of CT / bone scintigraphy etc. before treatment
Key secondary outcomes
2) Comparison of pathological findings after surgery or biopsy and PSMA-PET-positive lesions
3) Follow-up of PSMA-PET compared to conventional imaging findings of CT / bone scintigraphy etc. after treatment
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
Diagnosis
Type of intervention
| Other |
Interventions/Control_1
PET examination
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
Adult men who meet any one of the following criteria:
(1) Patient who is diagnosed as prostate cancer, and undergo CT and/or bone scintigraphy or will undergo.
(2) Patient who represent PSA elevation after local treatment (surgery or radiotherapy) for prostate cancer, and undergo CT and/or bone scintigraphy or will undergo (so-called PSA failure)
(3) Patient with castration-resistant prostate cancer without metastasis on CT or bone scintigraphy who will undergo treatment using oral androgen receptor signaling inhibitors
(4) Patient with castration-resistant prostate cancer who is confirmed metastasis by CT and/or bone scintigraphy
Key exclusion criteria
(1) Patient who cannot keep the body position for 30 minutes.
(2) Others who are regarded as unsuitable for enrollment in the opinion of research staff.
Target sample size
250
Research contact person
Name of lead principal investigator
| 1st name | Tadashi |
| Middle name | |
| Last name | Watabe |
Organization
Osaka University Graduate School of Medicine
Division name
Nuclear Medicine and Tracer Kinetics
Zip code
565-0871
Address
2-2 Yamadaoka, Suita, Osaka, 565-0871, JAPAN
TEL
06-6879-3461
watabe@tracer.med.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | Tasashi |
| Middle name | |
| Last name | Watabe |
Organization
Osaka University Graduate School of Medicine
Division name
Nuclear Medicine and Tracer Kinetics
Zip code
565-0871
Address
2-2 Yamadaoka, Suita, Osaka, 565-0871, JAPAN
TEL
06-6879-3461
Homepage URL
watabe@tracer.med.osaka-u.ac.jp
Sponsor or person
Institute
Osaka University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
AMED
Organization
Division
Category of Funding Organization
Government offices of other countries
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Medical Center for Translational and Clinical Research
Address
2-2 Yamadaoka, Suita, Osaka, 565-0871, JAPAN
Tel
06-6210-8289
mirai@hp-mctr.med.osaka-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
| 2019 | Year | 09 | 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
Enrolling by invitation
Date of protocol fixation
| 2019 | Year | 08 | Month | 16 | Day |
Date of IRB
| 2019 | Year | 08 | Month | 19 | Day |
Anticipated trial start date
| 2019 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 08 | Month | 16 | Day |
Last modified on
| 2023 | Year | 02 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042995
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
