UMIN-CTR Clinical Trial

Basic information
Public title	Intraoperative photodynamic diagnosis of prostate cancer using fluorescence cystoscopy with 5-aminolevulinic acid (5-ALA) to detect the residual cancer in the surgical margin of prostatectomy
Acronym	Intraoperative photodynamic diagnosis of prostate cancer
Scientific Title	Intraoperative photodynamic diagnosis of prostate cancer using fluorescence cystoscopy with 5-aminolevulinic acid (5-ALA) to detect the residual cancer in the surgical margin of prostatectomy
Scientific Title:Acronym	Intraoperative photodynamic diagnosis of prostate cancer
Region	Japan

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

Objectives
Narrative objectives1	To investigate the efficacy of the intraoperative photodynamic diagnosis of prostate cancer using fluorescence cystoscopy with 5-aminolevulinic acid (5-ALA) to detect the residual cancer in the surgical margin of prostatectomy
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Diagnostic accuracy: The levels in images of the 5-ALA-induced fluorescence were compared with the pathological results.
Key secondary outcomes	Safety: The occurrence frequency and degree of adverse event were investigated through the procedures.

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Diagnosis
Type of intervention	Medicine Device,equipment Maneuver
Interventions/Control_1	Three to four hours prior to operation 1.0g 5-aminolevulinic acid (5-ALA) (unapproved drug by Japanese pharmaceutical affairs law) dissolved in 50ml of 5% glucose solution was administrated orally (1.0g/50ml). For fluorescence excitation a blue light source (D-Light AF System) was used. Under fluorescence light guidance outputted by light source apparatus and videocamera system (Endovision TELECAM SL/IPM-PPD System), fluorescence lesions were recorded and resected.
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	80 years-old >
Gender	Male
Key inclusion criteria	Patient who has localized prostate cancer indicated for prostatectomy (open surgery, laparoscopic surgery or robot-assisted surgery)
Key exclusion criteria	Patient who has potential complication of local disorder and systematic absorption of 5-ALA such as solar photosensitivity nad liver dysfunction.
Target sample size	30

Research contact person
Name of lead principal investigator	1st name Middle name Last name Akio Matsubara
Organization	Hiroshima University
Division name	Department of Urology
Zip code
Address	1-2-3, kasumi, Minami-ku, Hiroshima, Hiroshima, Japan
TEL	082-257-5242
Email	urology@hiroshima-u.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Kanao Kobayashi
Organization	Hiroshima University
Division name	Department of Urology
Zip code
Address	1-2-3, kasumi, Minami-ku, Hiroshima, Hiroshima, Japan
TEL	082-257-5242
Homepage URL
Email	urology@hiroshima-u.ac.jp

Sponsor
Institute	Department of Urology, Hiroshima University
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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	広島大学病院

Other administrative information
Date of disclosure of the study information	2013 Year 09 Month 14 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
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	2011 Year 05 Month 02 Day
Date of IRB	2011 Year 06 Month 06 Day
Anticipated trial start date	2011 Year 06 Month 01 Day
Last follow-up date	2016 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2013 Year 09 Month 14 Day
Last modified on	2019 Year 08 Month 09 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006675