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

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 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


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

Value
https://center6.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