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UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000016924
Receipt No. R000019645
Scientific Title Studies on the safety and efficacy of focal transurethral resection of prostate cancer as a focal therapy for localized prostate cancer
Date of disclosure of the study information 2015/03/26
Last modified on 2016/04/28

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Basic information
Public title Studies on the safety and efficacy of focal transurethral resection of prostate cancer as a focal therapy for localized prostate cancer
Acronym Focal transurethral resection of prostate cancer (TUR-PCa) for localized prostate cancer
Scientific Title Studies on the safety and efficacy of focal transurethral resection of prostate cancer as a focal therapy for localized prostate cancer
Scientific Title:Acronym Focal transurethral resection of prostate cancer (TUR-PCa) for localized prostate cancer
Region
Japan

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

Objectives
Narrative objectives1 As the number of patients with low-volume, low-grade localised prostate cancer (PCa) increased, less invasive focal therapies have been introduced. We plan to study whether focal TUR-PCa could be an option among focal therapies against localized prostate cancer.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Others
Developmental phase Not applicable

Assessment
Primary outcomes biochemical non-recurrence rate
Key secondary outcomes PSA

Base
Study type

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
Maneuver
Interventions/Control_1 Focal transurethral resection of prostate cancer (TUR-PCa)
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
90 years-old >=
Gender Male
Key inclusion criteria Patients with localized prostate cancer (T1,2N0M0)
Patients with BPH
Patients who agreed to be enrolled in the study
Key exclusion criteria Patients who have cancer foci near bilateral nerurovascular bundle
Patients who are considered not to tolerate TURP
Patients who are considered inappropriate by the doctors
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takeshi Matsuura
Organization Matsubara Tokushukai Hospital
Division name Urology
Zip code
Address 7-13-26 Amami-Higashi, Matsubara, Osaka, Japan
TEL 072-334-3400
Email tmatsuura-jua@umin.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Takeshi Matsuura
Organization Matsubara Tokushukai Hospital
Division name Urology
Zip code
Address 7-13-26 Amami-Higashi, Matsubara, Osaka, Japan
TEL 072-334-3400
Homepage URL http://www.matubara.tokushukai.or.jp/
Email tmatsuura-jua@umin.ac.jp

Sponsor
Institute Department of Urology
Matsubara Tokushukai Hospital
Institute
Department

Funding Source
Organization institute to carry out the study
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization Japan

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

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 松原徳洲会病院(大阪)
こうない坂医院(高知)

Other administrative information
Date of disclosure of the study information
2015 Year 03 Month 26 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
2015 Year 03 Month 20 Day
Date of IRB
Anticipated trial start date
2015 Year 03 Month 26 Day
Last follow-up date
2020 Year 12 Month 31 Day
Date of closure to data entry
2021 Year 03 Month 31 Day
Date trial data considered complete
2021 Year 06 Month 30 Day
Date analysis concluded
2021 Year 12 Month 31 Day

Other
Other related information

Management information
Registered date
2015 Year 03 Month 26 Day
Last modified on
2016 Year 04 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019645

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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