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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000032554
Receipt No. R000036994
Scientific Title Targeted focal cryotherapy of localized prostate cancer
Date of disclosure of the study information 2018/09/01
Last modified on 2018/05/11

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Basic information
Public title Targeted focal cryotherapy of localized prostate cancer
Acronym FOCAL CRYO study
Scientific Title Targeted focal cryotherapy of localized prostate cancer
Scientific Title:Acronym FOCAL CRYO study
Region
Japan

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

Objectives
Narrative objectives1 To demonstrate the effectiveness for a therapeutic option of targeted focal cryotherapy for the localized three-dimensionally mapped prostate cancer lesion using minimally invasive image-guided cryoablation of prostate cancer
Basic objectives2 Others
Basic objectives -Others To demonstrate the minimally invasive therapeutic option to maintain quality-of-life with preservation of the clinically insignificant lesion and/or healthy prostate and functional peri-prostatic anatomy
Trial characteristics_1 Others
Trial characteristics_2 Others
Developmental phase Not applicable

Assessment
Primary outcomes cancer control of clinically significant cancer lesion
Key secondary outcomes Patient reported quality-of-life by EPIC questionnaire

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 Treatment
Type of intervention
Device,equipment
Interventions/Control_1 Percutaneous cryosurgery
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
50 years-old <=
Age-upper limit
85 years-old >=
Gender Male
Key inclusion criteria 1) Clinically significant cancer lesion proven by prostate biopsy and MRI
2) The targeted prostate cancer lesion to have three-dimensional distance of >5mm from the functional anatomy
3) No distant metastasis
Key exclusion criteria 1) Drug treatment for prostate cancer within 90 days from consented day
2) Anti-androgen therapy for BPH within 90 days from consented day
3) Difficulty of undergoing transrectal ultrasonography
4) Active cancer in other organ
5) Attending physician determines that the ineligible
Target sample size 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Osmau Ukimura, MD, PhD
Organization Kyoto Prefectural Univeristy of Medicine
Division name Urology
Zip code
Address Kawaramachi-Hirokoji, Kyoto, 602-8566
TEL 075-251-5595
Email ukimura@koto.kpu-m.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Osamu Ukimura, MD, PhD
Organization Kyoto Prefectural Univeristy of Medicine
Division name Urology
Zip code
Address Kawaramachi-Hirokoji, Kyoto, 602-8566
TEL 075-251-5595
Homepage URL https://www.KPUM-urology.com
Email uro1@koto.kpu-m.ac.jp

Sponsor
Institute Kyoto Prefectural Univeristy of Medicine
Institute
Department

Funding Source
Organization Kyoto Prefectural Univeristy of Medicine
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor Kyoto Min-iren Cyuo Hospital
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 京都府立医科大学付属病院

Other administrative information
Date of disclosure of the study information
2018 Year 09 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 Preinitiation
Date of protocol fixation
2018 Year 09 Month 01 Day
Date of IRB
Anticipated trial start date
2018 Year 09 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

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


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036994

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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