UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A feasibility study of photoacoustic imaging system for detection of prostate cancer
Title of the study (Brief title)	Photoacoustic imaging for detection of prostate cancer
Region	Japan

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

Objectives
Narrative objectives1	To investigate the photoacoustic imaging findings of prostate cancer and to study the feasibility in prostate cancer imaging.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Positive predictive value of photoacoustic imaging-guided prostate biopsy in detecting prostate cancer
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	Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Diagnosis
Type of intervention	Device,equipment
Interventions/Control_1	Under local anesthesia, photoacoustic images of the prostate are taken by using transrectal probe for photoacoustic images. Patterns of photoacoustic images and their location are reviewed and targetted biopsy for cancerous areas are performed.
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	Not applicable
Gender	Male
Key inclusion criteria	1. Over 20-year old 2. Having written informed consent 3. Serum PSA greater than 4.0 ng/ml 4. Prostate biopsy is scheduled
Key exclusion criteria	Patients who have no informed consent, or those who are judged as inadequate.
Target sample size	60

Research contact person
Name of lead principal investigator	AKIO HORIGUCHI
Organization	National Defense Medical College
Division name	Department of Urology
Address	Namiki 3-2, Tokorozawa, Saitama 359-8513, Japan
TEL	04-2995-1211
Email	impreza@ndmc.ac.jp

Public contact
Name of contact person	MIYA ISHIHARA
Organization	National Defense Medical College
Division name	Department of Medical Engineering
Address	Namiki 3-2, Tokorozawa, Saitama 359-8513, Japan
TEL	04-2995-1211
Homepage URL
Email	kobako@ndmc.ac.jp

Sponsor
Institute	Ministry of Defense
Institute
Department

Funding Source
Organization	AMED
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 05 Month 01 Day

Progress
Recruitment status	Recruiting
Date of protocol fixation	2017 Year 03 Month 15 Day
Anticipated trial start date	2017 Year 03 Month 15 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	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2017 Year 04 Month 30 Day
Last modified on	2017 Year 04 Month 30 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031146