UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024237 |
|---|---|
| Receipt number | R000027908 |
| Scientific Title | Evaluation of therapeutic effect in metastatic castration-resistant prostatic cancer using FDG-PET/CT |
| Date of disclosure of the study information | 2016/12/19 |
| Last modified on | 2019/02/06 10:16:39 |
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Basic information
Public title
Evaluation of therapeutic effect in metastatic castration-resistant prostatic cancer using FDG-PET/CT
Acronym
FDG-PET/CT in metastatic castration-resistant prostatic cancer
Scientific Title
Evaluation of therapeutic effect in metastatic castration-resistant prostatic cancer using FDG-PET/CT
Scientific Title:Acronym
FDG-PET/CT in metastatic castration-resistant prostatic cancer
Region
| Japan |
Condition
Condition
metastatic castration-resistant prostatic cancer
Classification by specialty
| Urology | Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
In order to evaluate the clinical usefulness of FDG-PET/CT parameter as an imaging biomarker in determining the effect of drug therapy for patients with metastatic castration-resistant prostatic cancer.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1. FDG uptake parameters in metastatic lesions obtained before and 12 weeks after the start of treatment
2. Number of bone metastases detected by bone scintigraphy performed before and 12 weeks after the start of treatment
3. Size of metastatic lesion detected by X-ray CT performed before and 12 weeks after the start of treatment
4. Serum PSA levels before and 12 weeks after the start of treatment
Key secondary outcomes
Prognostic information of mid-term follow-up patients
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male
Key inclusion criteria
1. Patients who are diagnosed to have metastatic castration-resistant prostate cancer in the Department of Urology, Kyoto University Hospital.
2. Patients who have metastatic lesions confirmed by bone scintigraphy and/or X-ray CT.
3. Patients who are going to be treated with abiraterone or enzalutamide.
4. Patients aged over 20 years old.
5. Patients who can read and understand the document of this study and have the ability to judge on the participation to this study.
Key exclusion criteria
1. Patients who have problems in communication.
2. Patients with deteriorated general condition.
3. Patients with severe hepatic/renal dysfunction.
4. Patients with uncontrollable diabetes mellitus.
5. Patients who received FDG-PET/CT within 3 weeks of informed consent.
6. Patients to whom physicians judged inappropriate for this study.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kaori Togashi |
Organization
Kyoto University Hospital
Division name
Department of Diagnostic Radiology
Zip code
Address
54 Kawahara-cho, Shogoin, Sakyo-ku, Kyoto 606-8507, Japan
TEL
075-751-3760
ktogashi@kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tsuneo Saga |
Organization
Kyoto University Hospital
Division name
Department of Diagnostic Radiology
Zip code
Address
54 Kawahara-cho, Shogoin, Sakyo-ku, Kyoto 606-8507, Japan
TEL
075-751-3760
Homepage URL
saga@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Dapartment of Diagnostic Radiology
Kyoto University Hospital
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology, Japan
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
Address
Tel
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 | 12 | 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
Terminated
Date of protocol fixation
| 2016 | Year | 09 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 01 | Month | 17 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Patients with metastatic castration-resistant prostatic cancer, who are going to be treated with abiraterone or enzalutamide, receive FDG-PET/CT, bone scintigraphy, X-ray-CT and PSA assay before and 12 weeks after the start of treatment. Treatment effect was determined based on the change in PSA levels and the efficacy of FDG-PET/CT parameter in the early evaluation of treatment effect will be compared with that of bone scintigraphy and X-ray CT. For patients whose follow-up data are available, above parameters will be correlated with mid-term prognoses.
Management information
Registered date
| 2016 | Year | 09 | Month | 30 | Day |
Last modified on
| 2019 | Year | 02 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027908
