UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Initial clinical evaluation of [18F]FSU-880, a PET probe targeting PSMA; safety, distribution, dosimetry and accumulation in prostate cancer.
Title of the study (Brief title)	Initial clinical evaluation of [18F]FSU-880, a PET probe targeting PSMA.
Region	Japan

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

Objectives
Narrative objectives1	To evaluate the safety, distribution, dosimetry of [18F]FSU-880, a low molecular weight PET probe targeting PSMA that is highly expressed on prostate cancer cells, and to verify the accumulation of [18F]FSU-880 in prostate cancer tissue.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Vital signs and blood and urine analysis data before and after administration of [18F]FSU-880. Dosimetry calculation data based on serial change of [18F]FSU-880 distribution. Qualitative and semi-quantitative uptake of [18F]FSU-880 in known prostate cancer tissue.
Key secondary outcomes

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	Device,equipment
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 having metastatic/recurrent prostate cancer that is confirmed by pathological or imaging diagnosis. 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 written informed consent on this study.
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	6

Research contact person
Name of lead principal investigator	Kaori Togashi
Organization	Kyoto University Hospital
Division name	Department of Diagnostic Radiology
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	Tsuneo Saga
Organization	Kyoto University Hospital
Division name	Department of Diagnostic Radiology
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	Department of Diagnostic Radiology 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)

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	2017 Year 12 Month 25 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 09 Month 29 Day
Anticipated trial start date	2017 Year 12 Month 25 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	Published
URL releasing results
Results
Other related information

Management information
Registered date	2017 Year 09 Month 29 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=R000033503