UMIN-CTR Clinical Trial

Basic information
Public title	Clinical utility of PET/CT with 18F-FSU-880 for recurrent prostate cancer
Acronym	PSMA PET for recurrent prostate cancer
Scientific Title	Clinical utility of PET/CT with 18F-FSU-880 for recurrent prostate cancer
Scientific Title:Acronym	PSMA PET for recurrent prostate cancer
Region	Japan

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

Objectives
Narrative objectives1	To investigate the clinical utility of FSU-880-PET/CT in patients with known or suspected recurrent prostate cancer
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase	Phase II

Assessment
Primary outcomes	presence or absence of abnormal uptake of FSU-880
Key secondary outcomes	Time course of uptake and/or tumor-to-background ratio in a lesion

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification	NO
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	No need to know

Intervention
No. of arms	1
Purpose of intervention	Diagnosis
Type of intervention	Medicine
Interventions/Control_1	Collect PET/CT data after intravenous administration of [18F]FSU-880 (approximately 185MBq)that is produced by automated synthetic device. PET/CT data collection is finished in 1 day.
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	85 years-old >=
Gender	Male
Key inclusion criteria	1.Patients who are suspected of having recurrence due to their increased PSA or diagnostic imaging after surgery for prostate cancer 2. Patients who are determined to be appropriate for this study by participating physicians according to the results of physical examination and blood/urine/physiological function tests. 3. Patients who give us written informed consent
Key exclusion criteria	1. Patients having severe communication problem. 2. Patients with severe general condition. 3. Patients having severe renal dysfunction (eGFR<39mL/min/1.73m3) expected to affect the distribution of [18F]FSU-880.. 4. Patients to whom participating physicians judged to be inappropriate for this study.
Target sample size	100

Research contact person
Name of lead principal investigator	1st name Yuji Middle name Last name Nakamoto
Organization	Kyoto University Hospital
Division name	Department of Radiology
Zip code	606-8507
Address	54 Kawahara-cho, Shogoin, Sakyo-ku, Kyoto 606-8507, Japan
TEL	075-751-3760
Email	ynakamo1@kuhp.kyoto-u.ac.jp

Public contact
Name of contact person	1st name Yoichi Middle name Last name Shimizu
Organization	Kyoto University Hospital
Division name	Department of Radiology
Zip code	606-8507
Address	54 Kawahara-cho, Shogoin, Sakyo-ku, Kyoto 606-8507, Japan
TEL	075-751-3760
Homepage URL
Email	yoichis@kuhp.kyoto-u.ac.jp

Sponsor
Institute	Kyoto University Hospital
Institute
Department

Funding Source
Organization	Japan Agency for Medical Research and Development
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	Kyoto University Graduate School and Faculty of Medicine, Ethics Committee
Address	Yoshidakonoe, Sakyo-ku, Kyoto
Tel	075-753-4680
Email	ethcom@kuhp.kyoto-u.ac.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

Other administrative information
Date of disclosure of the study information	2018 Year 10 Month 01 Day

Related information
URL releasing protocol
Publication of results	Published

Result
URL related to results and publications
Number of participants that the trial has enrolled	74
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	Completed
Date of protocol fixation	2018 Year 09 Month 18 Day
Date of IRB	2018 Year 12 Month 27 Day
Anticipated trial start date	2019 Year 04 Month 01 Day
Last follow-up date	2021 Year 09 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2018 Year 09 Month 18 Day
Last modified on	2022 Year 09 Month 21 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000038979