UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Exploratory clinical study on Indocyanine Green (ICG) navigated lymph node dissection in robot-assisted radical prostatectomy
Title of the study (Brief title)	RARP-ICG study
Region	Japan

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

Objectives
Narrative objectives1	We will explore the possibility of individualized pelvic lymph node dissection according to individual differences in robot-assisted radical prostatectomy surgery.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Lymph flow evaluatable ratio, lymph flow pattern classifiable ratio, lymph flow pattern classifiable ratio by lesion site, classification lymph flow pattern intra-lymph node metastasis rate
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	Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Diagnosis
Type of intervention	Medicine
Interventions/Control_1	After injecting ICG into the prostate gland, observe with a near infrared (NIR) camera and classify lymph flow. The ICG positive site within the template dissection area is dissected and additionally dissected out of the ICG positive site outside the template dissection supernatant is 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	75 years-old >=
Gender	Male
Key inclusion criteria	1) Diagnosed as prostate cancer pathologically by prostate biopsy 2) Diagnosed as localized prostate cancer (T1-2N0M0) or locally advanced cancer (T3aN0M0) by DRE, CT, MRI 3) 20 years old and over, under 75 4) ECOG performance status score: 0 and 1 5) With or without measurable lesions 6) Provision of pretreatment: No history of hormone therapy, no history of surgery in the pelvis, no history of operation of the prostate 7) No restrictions on concomitant medications and combination therapy 8) With regard to complications, there is no restriction as long as it is judged that robot-assisted prostatectomy and extended lymph node dissection is possible by the attending physician 9) About patient participation The patient got consent in writing from the patient himself
Key exclusion criteria	Exclude those with allergic history in ICG
Target sample size	70

Research contact person
Name of lead principal investigator	Hiroyuki Fujimoto
Organization	National Cancer Center Hospital:Tsukiji Campus
Division name	Urology division
Address	5-1-1 Tsukiji, Chuo-ku, Tokyo 104-0045, Japan
TEL	03-3542-2511
Email	hfujimot@ncc.go.jp

Public contact
Name of contact person	Tomohiko Hara
Organization	National Cancer Center Hospital:Tsukiji Campus
Division name	Urology division
Address	5-1-1 Tsukiji, Chuo-ku, Tokyo 104-0045, Japan
TEL	03-3542-2511
Homepage URL
Email	thara@ncc.go.jp

Sponsor
Institute	National Cancer Center Hospital:Tsukiji Campus
Institute
Department

Funding Source
Organization	Urology division National Cancer Center Hospital:Tsukiji Campus
Organization
Division
Category of Funding Organization	Government offices of other countries
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 02 Month 01 Day

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2016 Year 11 Month 22 Day
Anticipated trial start date	2017 Year 02 Month 01 Day
Last follow-up date	2020 Year 03 Month 31 Day
Date of closure to data entry	2020 Year 03 Month 31 Day
Date trial data considered complete	2020 Year 04 Month 30 Day
Date analysis concluded	2021 Year 03 Month 31 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2016 Year 11 Month 25 Day
Last modified on	2018 Year 05 Month 28 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000028755