UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000060979 |
|---|---|
| Receipt number | R000069081 |
| Scientific Title | A Study on the Clinical Features of Metastatic Castration-Resistant Prostate Cancer Using PSMA-PET and FDG-PET |
| Date of disclosure of the study information | 2026/03/19 |
| Last modified on | 2026/03/18 23:29:44 |
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Basic information
Public title
A Study on the Clinical Features of Metastatic Castration-Resistant Prostate Cancer Using PSMA-PET and FDG-PET
Acronym
Analysis of Prostate Cancer Using PSMA-PET and FDG-PET
Scientific Title
A Study on the Clinical Features of Metastatic Castration-Resistant Prostate Cancer Using PSMA-PET and FDG-PET
Scientific Title:Acronym
Analysis of Prostate Cancer Using PSMA-PET and FDG-PET
Region
| Japan |
Condition
Condition
Metastatic Castration-Resistant Prostate Cancer
Classification by specialty
| Urology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to elucidate the tumor characteristics in patients with metastatic castration-resistant prostate cancer undergoing 68Ga-PSMA-PET/CT, using FDG-PET/CT performed concurrently.
Basic objectives2
Others
Basic objectives -Others
To evaluate the association between PSMA expression and clinical information (treatment history, prognosis) as well as tumor characteristics (pathological grade, tumor markers).
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To evaluate the association between PSMA expression and tumor characteristics in patients with metastatic castration-resistant prostate cancer using a combination of 68Ga-PSMA-PET/CT and FDG-PET/CT.
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
Diagnosis
Type of intervention
| Medicine |
Interventions/Control_1
FDG-PET/CT
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
| Not applicable |
Gender
Male
Key inclusion criteria
Patients with metastatic castration-resistant prostate cancer undergoing PSMA-PET/CT imaging to aid in determining eligibility for radioligand therapy
Key exclusion criteria
Individuals who declined to participate in this study
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Koji |
| Middle name | |
| Last name | Hatano |
Organization
The University of Osaka Graduate School of Medicine
Division name
Urology
Zip code
565-0871
Address
Yamadaoka 2-2, Suita
TEL
06-6879-3531
koj.hatan@gmail.com
Public contact
Name of contact person
| 1st name | Koji |
| Middle name | |
| Last name | Hatano |
Organization
The University of Osaka Graduate School of Medicine
Division name
Urology
Zip code
565-0871
Address
Yamadaoka 2-2, Suita
TEL
06-6879-3531
Homepage URL
koj.hatan@gmail.com
Sponsor or person
Institute
The University of Osaka
Institute
Department
Personal name
Funding Source
Organization
The University of Osaka
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
The University of Osaka Graduate School of Medicine
Address
2-2 Yamadaoka, Suita
Tel
06-6879-3531
koj.hatan@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
大阪府
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 03 | Month | 19 | 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
Preinitiation
Date of protocol fixation
| 2026 | Year | 03 | Month | 18 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2031 | Year | 12 | 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
| 2026 | Year | 03 | Month | 18 | Day |
Last modified on
| 2026 | Year | 03 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069081
