UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050997 |
|---|---|
| Receipt number | R000058135 |
| Scientific Title | Primary focal therapy for prostate cancer using low-dose-rate brachytherapy |
| Date of disclosure of the study information | 2023/05/07 |
| Last modified on | 2023/05/20 21:00:30 |
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Basic information
Public title
Primary focal therapy for prostate cancer using low-dose-rate brachytherapy
Acronym
Primary focal brachytherapy for prostate cancer
Scientific Title
Primary focal therapy for prostate cancer using low-dose-rate brachytherapy
Scientific Title:Acronym
Primary focal brachytherapy for prostate cancer
Region
| Japan |
Condition
Condition
prostate cancer
Classification by specialty
| Urology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy and safety of primary focal brachytherapy for prostate cancer
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
adverse events, urinary function, sexual function, recurrence-free survival, salvage treatment-free survival, additional treatment-free survival
Key secondary outcomes
overall survival, disease-specific survival
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment | Maneuver |
Interventions/Control_1
brachytherapy
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
| Not applicable |
Gender
Male
Key inclusion criteria
1) adenocarcinoma
2) the presence of area where immediate treatment is unnecessary
3) performance status 0-1
Key exclusion criteria
1) severe comorbidity
2) history of radiation therapy to pelvic cavity
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Yoh |
| Middle name | |
| Last name | Matsuoka |
Organization
Saitama Cancer Center
Division name
Urology
Zip code
362-0806
Address
780 Komuro, Ina, Saitama
TEL
048-722-1111
matsuoka.yoh@saitama-pho.jp
Public contact
Name of contact person
| 1st name | Yoh |
| Middle name | |
| Last name | Matsuoka |
Organization
Saitama Cancer Center
Division name
Urology
Zip code
362-0806
Address
780 Komuro, Ina, Saitama
TEL
048-722-1111
Homepage URL
matsuoka.yoh@saitama-pho.jp
Sponsor or person
Institute
Saitama Cancer Center
Institute
Department
Personal name
Funding Source
Organization
Saitama Cancer Center
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
Saitama Cancer Center
Address
780 Komuro, Ina, Saitama
Tel
048-722-1111
g.iji-ka@saitama-pho.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
埼玉県立がんセンター（埼玉県）
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 05 | Month | 07 | 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
| 2023 | Year | 03 | Month | 26 | Day |
Date of IRB
| 2023 | Year | 04 | Month | 26 | Day |
Anticipated trial start date
| 2023 | Year | 05 | Month | 07 | Day |
Last follow-up date
| 2038 | 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
| 2023 | Year | 05 | Month | 07 | Day |
Last modified on
| 2023 | Year | 05 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000058135
