臨床研究等提出・公開システム

Date of registration	Oct. 19, 2010
Last modified on	Dec. 17, 2018
Trial ID	jRCT2080221271

Scientific Title	DD-723 Phase III Clinical Trial - Confirmatory Study in Subjects with Suspected Prostate Cancer -
Public Title	DD-723 Phase III Clinical Trial (Prostate)

Completion Date or Terminated date
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
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
	Address
	Phone Number
	E-mail Address

Contact for Public Queries	Name
	Contact Name for Public Queries	Daiichi Sankyo Co., Ltd.
	Address	http://www.daiichisankyo.co.jp/contact/clinical/index.html
	Phone Number
	E-mail Address

Recruitment Status

Date of First Enrolment
Target Sample Size		120
Study Type		Interventional
Study Design	Study Design	- Multicenter open-label study under central registration - Intra-individual comparison design
Study Design	Objective
Phase		3
Key inclusion & exclusion criteria	Inclusion Criteria	- Subjects with suspected prostate cancer who are undergoing prostate biopsy. - Subjects whose most recent PSA level is between 20.0 ng/mL and 4.0 ng/mL. - Subjects aged >=20 years old at the time of informed consent.
	Exclusion Criteria	- Items listed in the package insert (including absolute contraindications, careful administration, and precautions) to ensure safety. - Items related to safety and ethics. - Items related to surgery, procedures, and treatment that are considered likely to influence assessment of the efficacy and safety of DD-723.
	Minimum Age	20age old over
	Maximum Age	No limit
	Gender	Male
Health Condition or Problem Studied		Subjects with suspected prostate cancer
Intervention(s)		investigational material(s) Generic name etc : DD-723 INN of investigational material : Perflubutane Therapeutic category code : 729 Other diagnostic agents (except extracorporeal diagnostic medicines) Dosage and Administration for Investigational material : A single intravenous dose of 0.12 microL MB/kg administered via a forearm vein.
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome		Detection rate of prostate cancer in the subjects Biopsy results obtained at each participating institution
Secondary Outcome		1. Detection rate of prostate cancer per biopsy core 2. Assessment of the degree of malignancy 3. Assessment of contrast effect 1, 2. Biopsy results obtained at each participating institution 3. Assessment by investigator

Primary Sponsor	DAIICHISANKYO Co.,Ltd.
Secondary Sponsor

Name of Funding Organization
Name of Research Funding

Name of IRB
Address of IRB
Phone Number of IRB
E-mail Address of IRB
Status of IRB Review
Date of Approval by IRB

Secondary ID No.	JapicCTI-101308
Name of Other Registries

Countries / Regions of Recruitment

History of Changes

No	Publication date
11	Dec. 17, 2018	(this page)	Changes
10	Sept. 24, 2014	Detail	Changes
9	Sept. 24, 2014	Detail	Changes
8	Nov. 28, 2011	Detail	Changes
7	Nov. 28, 2011	Detail	Changes
6	July. 29, 2011	Detail	Changes
5	July. 29, 2011	Detail	Changes
4	Jan. 27, 2011	Detail	Changes
3	Jan. 27, 2011	Detail	Changes
2	Oct. 19, 2010	Detail	Changes
1	Oct. 19, 2010	Detail

List of change history