UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Diagnosis of prostate cancer using carbon-11 labeled choline PET/CT
Title of the study (Brief title)	Choline PET/CT for prostate cancer
Region	Japan

Condition
Condition	Prostate cancer
Classification by specialty	Urology Radiology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To improve the diagnostic accuracy for the metastasis of high-risk prostate cancer, and for the detection of recurrent foci in the PSA recurrence after therapy.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Positive predictive value
Key secondary outcomes	Additional information with 11C-choline PET/CT. Sensitivity. Clinical impact.

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	PET/CT imaging will be performed 5 min after injection of 11C-Choline. Images will be evaluated for the detection of lymphnode/bone metastasis.
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 of high risk group of prostate cancer: PSA level over 20ng/mL, Gleason score over 8. Patients suspected of recurrence of prostate cancer after therapy: Re-elevation of PSA level.
Key exclusion criteria	Those who have not signed the informed consent form. Those who are severe systemic condition with serious underlying disease. Those who have been decided not appropriate for enrollment by the investigator.
Target sample size	50

Research contact person
Name of lead principal investigator	Shigeru Minowada
Organization	National Center for Global Health and Medicine
Division name	Department of Urology
Address	1-21-1 Shinjuku-ku Tokyo, 162-8655 Japan
TEL	03-3202-7181
Email	sminowad@hosp.ncgm.go.jp

Public contact
Name of contact person	Kazuo Kubota, Yoko Miyata, Momoko Okasaki
Organization	National Center for Global Health and Medicine
Division name	Div.Nuclear Medicine, Dept.Radiology
Address	1-21-1 Shinjuku-ku Tokyo, 162-8655 Japan
TEL	03-3202-7181
Homepage URL
Email	rikensa@lily.ocn.ne.jp

Sponsor
Institute	National Center for Global Health and Medicine
Institute
Department

Funding Source
Organization	National Center for Global Health and Medicine, Department of Urology
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	国立国際医療研究センター病院 National Center for Global Health and Medicine

Other administrative information
Date of disclosure of the study information	2014 Year 03 Month 13 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 02 Month 20 Day
Anticipated trial start date	2014 Year 03 Month 14 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2014 Year 03 Month 09 Day
Last modified on	2016 Year 09 Month 11 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000015603