UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035440 |
|---|---|
| Receipt number | R000025154 |
| Scientific Title | Salvage local ablation therapy for radiation-recurrent prostate cancer |
| Date of disclosure of the study information | 2019/01/07 |
| Last modified on | 2021/01/05 12:09:31 |
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Basic information
Public title
Salvage local ablation therapy for radiation-recurrent prostate cancer
Acronym
Salvage ablation therapy for radiorecurrent prostate cancer
Scientific Title
Salvage local ablation therapy for radiation-recurrent prostate cancer
Scientific Title:Acronym
Salvage ablation therapy for radiorecurrent prostate cancer
Region
| Japan |
Condition
Condition
prostate cancer
Classification by specialty
| Urology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate oncological and funcitional outcomes of salvage high-intensity focused ultrasound(HIFU) in men with radiation -recurrent prostate cancer.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Serum PSA every 3 months
Key secondary outcomes
MRI
prostate biopsy
adverse event
QOL 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
High-intensity focused ultrasound therapy
once, 2-3 hours
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)recurrent prostate cancer after radiation treatment
2)Clinical T1-2, N0 at initial treatment
3)Serum PSA value < 10ng/ml
4)Age over 20 years old
Key exclusion criteria
1)Infecious disease at urinary tract and/or prostate
2)Metastatic disease
Target sample size
5
Research contact person
Name of lead principal investigator
| 1st name | Osamu |
| Middle name | |
| Last name | Ukimura |
Organization
Kyoto Prefectural University of Medicine
Division name
Department of Urology
Zip code
6028566
Address
465, Kajiityo, Kawaramachi-Hirokoji, Kamigyo, Kyoto
TEL
075-251-5595
uro@koto.kpu-m.ac.jp
Public contact
Name of contact person
| 1st name | Atsushi |
| Middle name | |
| Last name | Ochiai |
Organization
Kyoto prefectural University of Medicine
Division name
Department of Urology
Zip code
6028566
Address
465, Kajiityo, Kawaramachi-Hirokoji, Kamigyo, Kyoto
TEL
075-251-5595
Homepage URL
uro@koto.kpu-m.ac.jp
Sponsor or person
Institute
Kyoto Prfectural University of Medicine
Institute
Department
Personal name
Funding Source
Organization
Kyoto Prfectural University of Medicine
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Aiseikai Yamashina Hospital
Matsushita Memorial Hospital
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kyoto Prefectural University of Medicine
Address
465, Kajiityo, Kawaramachi-Hirokoji, Kamigyo, Kyoto
Tel
075-251-5595
uro@koto.kpu-m.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
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 01 | 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
0
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
Completed
Date of protocol fixation
| 2019 | Year | 01 | Month | 07 | Day |
Date of IRB
| 2017 | Year | 03 | Month | 29 | Day |
Anticipated trial start date
| 2019 | Year | 01 | Month | 07 | Day |
Last follow-up date
| 2020 | 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
| 2019 | Year | 01 | Month | 04 | Day |
Last modified on
| 2021 | Year | 01 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025154
