UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000034190
Receipt number R000038979
Scientific Title Clinical utility of PET/CT with 18F-FSU-880 for recurrent prostate cancer
Date of disclosure of the study information 2018/10/01
Last modified on 2022/09/21 09:58:14

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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 or person

Institute

Kyoto University Hospital

Institute

Department

Personal name



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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038979


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name