UMIN-CTR Clinical Trial

Basic information
Public title	The utility of 11C-choline PET/CT in prostate patients of PSA failure
Acronym	11C-choline PET/CT in PSA failure
Scientific Title	The utility of 11C-choline PET/CT in prostate patients of PSA failure
Scientific Title:Acronym	11C-choline PET/CT in PSA failure
Region	Japan

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

Objectives
Narrative objectives1	To prospectively compare the diagnostic aacuracy and clinical impact for restaging prostate cancer in patients with PSA failure between conventional imaging modalities (pelvis MRI, chest/abdomen CT, bone scintigraphy).
Basic objectives2	Others
Basic objectives -Others	To find the true usefulness of 11C-choline PET/CT for restaging prostate cancer after treatmen.t
Trial characteristics_1	Confirmatory
Trial characteristics_2	Explanatory
Developmental phase	Not applicable

Assessment
Primary outcomes	To compare diagnostic accuracy (ROC analysis, sensitivity, specificity, and accuracy) for diagnosing lymph node recurrence between 11C-choline PET/CT and chest/abdomen CT.
Key secondary outcomes	To compare diagnostic accuracy (ROC analysis, sensitivity, specificity, and accuracy) for diagnosing local recurrence and distant metastasis and clinical impact between 11C-choline PET/CT and chest/abdomen CT.

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Diagnosis
Type of intervention	Maneuver
Interventions/Control_1	11C-choline PET/CT, pelvic MRI, chest/abdomen CT, bone scintigraphy
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	50 years-old <=
Age-upper limit	100 years-old >=
Gender	Male
Key inclusion criteria	*The patients that the urology department chief physician judged an examination for 11C-Colin PET/CT to be necessary. *The patients who show PSA failure after the treatments. *The patients who underwent or will undergo pelvic MRI, chest/abdomen CT, bone scintigraphy. *The patients in good condition. *The patients who can understand study contents, and a written agreement is provided
Key exclusion criteria	*The patients who cannot keep face up position because of sharp pain in succession for around 30 minutes. *The patients with the extreme claustrophobia. *The patients whom the ADL which I become independent and can inspect is not kept. *The patients who a study person in charge is judged to be inappropriate.
Target sample size	50

Research contact person
Name of lead principal investigator	1st name Koichiro Middle name Last name Yamakado
Organization	Hyogo College of Medicine
Division name	Radiology
Zip code	663-8501
Address	Mukogawa-cho 1-1, Nishinomiya, Hyogo
TEL	0798-45-6362
Email	hirota-s@hyo-med.ac.jp

Public contact
Name of contact person	1st name Kazuhiro Middle name Last name Kitajima
Organization	Hyogo College of Medicine
Division name	Nuclear Medicine and PET Center
Zip code	663-8501
Address	Mukogawa-cho 1-1, Nishinomiya, Hyogo
TEL	0798-45-6883
Homepage URL
Email	ka-kitajima@hyo-med.ac.jp

Sponsor
Institute	Radiology, Hyogo College of Medicine
Institute
Department

Funding Source
Organization	Hyogo-prefecture health Foundation Shinryoku-kai
Organization
Division
Category of Funding Organization	Non profit foundation
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Radiology, Hyogo College of Medicine
Address	1-1 Mukogawa-cho 1-1, Nishinomiya, Hyogo 663-8501
Tel	0798-45-6883
Email	kazu10041976@yahoo.co.jp

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	兵庫医科大学病院（兵庫県）

Other administrative information
Date of disclosure of the study information	2015 Year 10 Month 01 Day

Related information
URL releasing protocol	http://www.hyo-med.ac.jp/department/radt/
Publication of results	Unpublished

Result
URL related to results and publications	Acta Med Okayama
Number of participants that the trial has enrolled	20
Results	Twenty Japanese prostate cancer patients underwent 11C-choline and FDG PET/CT. The sensitivity/specificity/accuracy/AUC for choline-PET for diagnosing local lesions were 90.9%/100%/95.0%/1.0, whereas those for FDG-PET were 45.5%/100%/75.0%/0.773. Those for choline-PET for node metastasis were 88.9%/100%/95.0%/0.944, and those for FDG-PET were 44.4%/100%/75.0%/0.722. Those for choline-PET for bone metastasis were 84.6%/100%/90.0%/0.951, and those for FDG-PET were 76.9%/100%/85.0%/0.962.
Results date posted	2022 Year 02 Month 13 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics	Patients scheduled to receive choline PET/CT
Participant flow	From the　Urology staff
Adverse events	None
Outcome measures	Diagnostic performance of detecting local prostate cancer, lymph node metastasis, and bone metastasis
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2015 Year 10 Month 01 Day
Date of IRB	2015 Year 08 Month 31 Day
Anticipated trial start date	2015 Year 10 Month 07 Day
Last follow-up date	2025 Year 12 Month 31 Day
Date of closure to data entry	2025 Year 12 Month 31 Day
Date trial data considered complete	2025 Year 12 Month 31 Day
Date analysis concluded	2025 Year 12 Month 31 Day

Other
Other related information

Management information
Registered date	2015 Year 09 Month 15 Day
Last modified on	2022 Year 02 Month 13 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000021692