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UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000024237
Receipt No. 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

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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
Email 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
Email saga@kuhp.kyoto-u.ac.jp

Sponsor
Institute Dapartment of Diagnostic Radiology
Kyoto University Hospital
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027908

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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