UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006734 |
|---|---|
| Receipt number | R000007219 |
| Scientific Title | Phase one/two study of focal salvage high-dose-rate brachytherapy for patient with PSA-failure after radiotherapy for prostate cancer |
| Date of disclosure of the study information | 2011/12/01 |
| Last modified on | 2017/02/21 06:37:27 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Phase one/two study of focal salvage high-dose-rate brachytherapy
for patient with PSA-failure after radiotherapy for prostate cancer
Acronym
Focal salvage high-dose-rate brachytherapy
for patient with PSA-failure after radiotherapy for prostate cancer
Scientific Title
Phase one/two study of focal salvage high-dose-rate brachytherapy
for patient with PSA-failure after radiotherapy for prostate cancer
Scientific Title:Acronym
Focal salvage high-dose-rate brachytherapy
for patient with PSA-failure after radiotherapy for prostate cancer
Region
| Japan |
Condition
Condition
local relapse case with prostate cancer after radiotherapy
Classification by specialty
| Medicine in general |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
safety of the therapy
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
side effect
Key secondary outcomes
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
| Other |
Interventions/Control_1
high-dose-rate 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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male
Key inclusion criteria
1prostate cancer
2relapse after radiotherapy less than 72Gy
3clinical stage: cT1caN0M0,PSA20ng/ml,anyGS
Key exclusion criteria
patients with double cancers
patients with hormon refractry
patients with unsuitable factors to carry out this salvage HDR-BT
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Junichi Hiratsuka |
Organization
Kawasaki Medical School
Division name
Radiation Oncology
Zip code
Address
577 Matsushima Kurashiki Okayama
TEL
086-462-1111
hiratuka@med.kawasaki-m.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Junichi Hiratsuka |
Organization
Kawasaki Medical School
Division name
Radiation Oncology
Zip code
Address
577 Matsushima Kurashiki
TEL
086-462-1111
Homepage URL
hiratuka@med.kawasaki-m.ac.jp
Sponsor or person
Institute
Department of Radiation Oncology,Kawasaki Medical School
Institute
Department
Personal name
Funding Source
Organization
Graant from mHDR Study Group
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2011 | Year | 12 | Month | 01 | 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
Terminated
Date of protocol fixation
| 2011 | Year | 11 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 12 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2011 | Year | 11 | Month | 16 | Day |
Last modified on
| 2017 | Year | 02 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007219
