臨床研究等提出・公開システム

Date of registration	Mar. 08, 2016
Last modified on	May. 20, 2022
Trial ID	jRCT2080223135

Scientific Title	Phase IIb Study of F-1311 in Patients with Prostate Cancer
Public Title	Phase IIb Study of F-1311 in Patients with Prostate Cancer

Completion Date or Terminated date	Mar. 12, 2018
Actual Enrolled Number
Baseline Characteristics
Participant flow
Adverse events
Primary Outcome Measures
Secondary Outcome Measures
Brief summary
Posting of journal publication
Date of the first journal publication of results
URL hyperlink(s) related to results and publications

Plan to share IPD	No
Plan description
URL link to protocol file(s)
Version of protocol file(s)	version: date:

Contact for Scientific Queries	Name
	Contact Name for Scientific Queries	PDRadiopharma Inc.
	Address	-
	Phone Number	-
	E-mail Address	s-clinicaltrial-info@pdradiopharma.com

Contact for Public Queries	Name
	Contact Name for Public Queries	PDRadiopharma Inc.
	Address	-
	Phone Number	-
	E-mail Address	s-clinicaltrial-info@pdradiopharma.com

Recruitment Status	completed

Date of First Enrolment		May. 24, 2016
Target Sample Size		56
Study Type		Interventional
Study Design	Study Design	multicenter, open-label
Study Design	Objective	diagnostic purpose
Phase		2
Key inclusion & exclusion criteria	Inclusion Criteria	-Biopsy confirmed presence of adenocarcinoma of the prostate gland. -Gleason score 6 or 7 -PSA < 10ng/mL
	Exclusion Criteria	-Subjects have received or have been receiving treatment or medication for prostate cancer. -Subjects have sever hepatic or renal dysfuction.
	Minimum Age	20age old over
	Maximum Age	No limit
	Gender	Male
Health Condition or Problem Studied		Prostate Cancer
Intervention(s)		investigational material(s) Generic name etc : F-1311 INN of investigational material : - Therapeutic category code : 43- Radioactive medicines Dosage and Administration for Investigational material : intravenous injection control material(s) Generic name etc : - INN of investigational material : - Therapeutic category code : Dosage and Administration for Investigational material : -
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome		efficacy Ability of F-1311 to accumulate in prostate cancer
Secondary Outcome		safety Adverse events

Primary Sponsor	PDRadiopharma Inc.
Secondary Sponsor	-

Name of Funding Organization	-
Name of Research Funding	-

Name of IRB	IRB of Tohoku University Hospital
Address of IRB	1-1, Seiryoutyo, Aobaku, Sendai, Miyagi, Japan
Phone Number of IRB	-
E-mail Address of IRB	-
Status of IRB Review	approved
Date of Approval by IRB	April. 25, 2016

Secondary ID No.	JapicCTI-163190
Name of Other Registries

Countries / Regions of Recruitment	Japan

History of Changes

No	Publication date
12	May. 20, 2022	(this page)	Changes
11	Dec. 17, 2018	Detail	Changes
10	Oct. 22, 2018	Detail	Changes
9	Oct. 22, 2018	Detail	Changes
8	July. 11, 2017	Detail	Changes
7	July. 11, 2017	Detail	Changes
6	Nov. 09, 2016	Detail	Changes
5	Nov. 09, 2016	Detail	Changes
4	June. 07, 2016	Detail	Changes
3	June. 07, 2016	Detail	Changes
2	Mar. 08, 2016	Detail	Changes
1	Mar. 08, 2016	Detail

List of change history