UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016924 |
|---|---|
| Receipt number | 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 | 2021/01/31 12:26:13 |
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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
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
| 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 | Takeshi |
| Middle name | |
| Last name | Takeshi |
Organization
Matsubara Tokushukai Hospital
Division name
Urology
Zip code
580-0032
Address
7-13-26 Amami-Higashi, Matsubara, Osaka, Japan
TEL
072-334-3400
tmatsuura-jua@umin.ac.jp
Public contact
Name of contact person
| 1st name | Takeshi |
| Middle name | |
| Last name | Matsuura |
Organization
Matsubara Tokushukai Hospital
Division name
Urology
Zip code
580-0032
Address
7-13-26 Amami-Higashi, Matsubara, Osaka 580-0032, Japan
TEL
072-334-3400
Homepage URL
http://www.matubara.tokushukai.or.jp/
tmatsuura-jua@umin.ac.jp
Sponsor or person
Institute
Department of Urology
Matsubara Tokushukai Hospital
Institute
Department
Personal name
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
Institutional Review Boare of Matsubara Tokushukai Hospital
Address
7-13-26 Amami-Higashi, Matsubara, Osaka 580-0032, Japan
Tel
072-334-3400
kiyoko.kuramitsu@tokushukai.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
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
Published
Result
URL related to results and publications
https://jeleu.com/index.php/JELEU/article/view/87
Number of participants that the trial has enrolled
36
Results
option as a focal therapy for localized prostate cancer.
Results date posted
| 2021 | Year | 01 | Month | 31 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2020 | Year | 06 | Month | 14 | Day |
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2015 | Year | 03 | Month | 20 | Day |
Date of IRB
| 2015 | Year | 03 | Month | 20 | Day |
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
| 2021 | Year | 01 | Month | 31 | Day |
Link to view the page
Value
https://center6.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 |
| 2020/12/04 | Publoshed Results.docx |
