UMIN-CTR Clinical Trial

Basic information
Public title	Identifying of index cancer among multiple cancer foci by methylation analysis using the ex vivo prostate needle biopsy from prostatectomy specimen
Acronym	Identifying of index cancer by the prostate needle biopsy
Scientific Title	Identifying of index cancer among multiple cancer foci by methylation analysis using the ex vivo prostate needle biopsy from prostatectomy specimen
Scientific Title:Acronym	Identifying of index cancer by the prostate needle biopsy
Region	Japan

Condition
Condition	prostate cancer
Classification by specialty	Urology
Classification by malignancy	Malignancy
Genomic information	YES

Objectives
Narrative objectives1	To identify the index cancer which determine the patient prognosis among the multiple prostate cancer foci with methylation analysis using an ex vivo needle biopsy specimens to compare between prostate normal tissue and prostate cancer tissue
Basic objectives2	Bio-equivalence
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Others
Developmental phase

Assessment
Primary outcomes	To identify the index cancer which determine the patient prognosis among the multiple prostate cancer foci with methylation analysis using ex vivo needle biopsy specimens to compare between prostate normal tissue and prostate cancer tissue
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	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Diagnosis
Type of intervention	Gene
Interventions/Control_1	Methylation analysis of prostate normal tissue and cancer tissue from multiple cancer foci, which are taken from ex vivo prostatectomy specimens by needle biopsy technique
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	90 years-old >=
Gender	Male
Key inclusion criteria	Inclusion criteria: 1) The patients who had histologically-confirmed prostate adenocarcinoma, agreed to undergo radical prostatectomy. 2) The patients had MR-visible prostate cancer lesion, confirmed by MRUS fusion biopsy. 3) The patients signed by themselves the informed consent document after understanding this study.
Key exclusion criteria	Exclusion criteria:. 1) Prior or concurrent chemotherapy or androgen deprivation therapy for the prostate cancer. 2) Prior radiotherapy to the prostate or lower pelvis 3) Concurrent systemic steroids therapy for different disease 4) Unsuitable for participant due to mental disorder 5) The attending physician has determined inappropriate
Target sample size	10

Research contact person
Name of lead principal investigator	1st name Middle name Last name Osamu Ukimura
Organization	Kyoto Prefectural University of Medicine
Division name	Urology
Zip code
Address	Kajiicho465 Kamigyoku Kyoto
TEL	075-251-5595
Email	uro@koto.kpu-m.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Masakatsu Oishi
Organization	Kyoto Prefectural University of Medicine
Division name	Urology
Zip code
Address	Kajiicho465 Kamigyoku Kyoto
TEL	075-251-5595
Homepage URL
Email	uro@koto.kpu-m.ac.jp

Sponsor
Institute	The department of Urology, Kyoto Prefectural University of Medicine
Institute
Department

Funding Source
Organization	The department of Urology, Kyoto Prefectural University of Medicine
Organization
Division
Category of Funding Organization	Other
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

Other administrative information
Date of disclosure of the study information	2016 Year 06 Month 01 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	Open public recruiting
Date of protocol fixation	2016 Year 04 Month 01 Day
Date of IRB	2016 Year 11 Month 29 Day
Anticipated trial start date	2016 Year 12 Month 13 Day
Last follow-up date	2022 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	2016 Year 04 Month 14 Day
Last modified on	2019 Year 10 Month 18 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000024761