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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000031566
Receipt No. R000036042
Scientific Title Focal cryotherapy for prostate cancer, a prospective study
Date of disclosure of the study information 2018/03/04
Last modified on 2019/03/16

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Basic information
Public title Focal cryotherapy for prostate cancer, a prospective study
Acronym Focal cryotherapy for localized prostate cancer
Scientific Title Focal cryotherapy for prostate cancer, a prospective study
Scientific Title:Acronym Focal cryotherapy for localized prostate cancer
Region
Japan

Condition
Condition 1 Localized prostate cancer
2 Local recurrent prostate cancer after definitive radiotherapy
Classification by specialty
Urology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To assess the efficacy and safety of focal cryotherapy for localized prostate cancer and the local recurrent prostate cancer after definitive radiotherapy.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Others
Trial characteristics_2 Others
Developmental phase Not applicable

Assessment
Primary outcomes Biochemical recurrence free survival
Key secondary outcomes (1) Overall survival
(2) Clinical progression free survival
(3) Prostate cancer specific survival
(4) Salvage treatment free survival
(5) biopsy results
(6) Adverse events
(7) QOL analysis

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 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
40 years-old <=
Age-upper limit
85 years-old >
Gender Male
Key inclusion criteria 1. Localized prostate cancer
1)Gleason score, under7
2) PSA <20ng/ml
3) Clinically significant cancer proven by MRI/US fusion biopsy and mltiparametric MRI imaging.
4) Except for targeted lesion, no MRI findings and Biopsy gleason score by transperineal saturation biopsy is under 6
5) Clinical T stage <T3a
2. Radiorecurence prostate cancer
1) Local recurrence prostate cancer after definitive radiotherapy
2) No distant metastasis
3) The serum PSA level is less than 20 ng/ml before salvage Tx
4) PS 0-1
5) No hormone therapy before recurrence.
Key exclusion criteria 1) Active cancer in other organ
2) Uncontrol HT, DM and ischmic heart disease
3) Severe brain disease
4) Collagen disease
5) uncontroled DM
6) uncontroled heart disease
7) The prostatectomy was performed before
6) Using steroid drug, excluding ointment
8) Attnding physician determines that the ineligible
Target sample size 60

Research contact person
Name of lead principal investigator
1st name Shin
Middle name
Last name Egawa
Organization Jikei University School of Medicine
Division name Urology
Zip code 1058461
Address 3-25-8, Nishishinbashi, Minato-ku, Tokyo
TEL 03-3433-1111
Email s-egpro@jikei.ac.jp

Public contact
Name of contact person
1st name Hiroshi
Middle name
Last name Sasaki
Organization Jikei University School of Medicine
Division name Urology
Zip code 1058461
Address 3-25-8, Nishishinbashi, Minato-ku, Tokyo
TEL 03-3433-1111
Homepage URL http://jikei-ur.umin.jp/
Email hs06@jikei.ac.jp

Sponsor
Institute Jikei University School of Medicine
Institute
Department

Funding Source
Organization Jikei Univerity School of Medicine
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 Jikei University IRB
Address 3-25-8, Nishishinbashi, Minato-ku Tokyo
Tel 0334331111
Email rinri@jikei.ac.jp

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 慈恵医大附属病院

Other administrative information
Date of disclosure of the study information
2018 Year 03 Month 04 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
2017 Year 12 Month 17 Day
Date of IRB
2017 Year 09 Month 04 Day
Anticipated trial start date
2018 Year 02 Month 01 Day
Last follow-up date
2026 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
2018 Year 03 Month 04 Day
Last modified on
2019 Year 03 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036042

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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