UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038131 |
|---|---|
| Receipt number | R000043449 |
| Scientific Title | Evaluation of SpaceOAR System when used to Create Space Between the Rectum and Prostate in Adult Men Undergoing First Time LDR Brachytherapy Monotherapy for Treatment of Localized Prostate Cancer |
| Date of disclosure of the study information | 2019/10/18 |
| Last modified on | 2021/09/30 13:06:47 |
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Basic information
Public title
Evaluation of SpaceOAR System when used to Create Space Between the Rectum and Prostate in Adult Men Undergoing First Time LDR Brachytherapy Monotherapy for Treatment of Localized Prostate Cancer
Acronym
SpaceOAR system PMS
Scientific Title
Evaluation of SpaceOAR System when used to Create Space Between the Rectum and Prostate in Adult Men Undergoing First Time LDR Brachytherapy Monotherapy for Treatment of Localized Prostate Cancer
Scientific Title:Acronym
SpaceOAR system PMS
Region
| Japan |
Condition
Condition
Prostate cancer
Classification by specialty
| Urology | Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To obtain post market patient information of the SpaceOAR System injected between the rectum and prostate in adult men undergoing first time LDR brachytherapy (LDR-BT) monotherapy for treatment of localized prostate cancer.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Phase IV
Assessment
Primary outcomes
- Mean mid gland (axial) perirectal space following SpaceOAR hydrogel implantation (mm).
- Change in prostate dimensions before and after SpaceOAR placement.
Key secondary outcomes
- Percent of patients meeting the rectum radiation dose constraints
- Change in dosimetry data from Pre-placement to Day 1 and Day 30; including, radiation doses delivered to the prostate, rectum and urethra
- Percent of patients who experience a SpaceOAR procedural adverse event
- Percent and grade of patients experiencing rectal and urinary toxicity assessed via CTCAE v.4.0. Acute (implant to 3 months) and late (3 to 15 months) toxicity will be evaluated
- All adverse events, device malfunctions and all serious adverse events
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
SpaceOAR system
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
Men undergoing LDR Brachytherapy monotherapy for localized Prostate Cancer in accordance with the IFU and Appropriate Use Document.
Key exclusion criteria
NA
Target sample size
46
Research contact person
Name of lead principal investigator
| 1st name | Kazuo |
| Middle name | |
| Last name | Kawahara |
Organization
Boston Scientific Japan K.K.
Division name
Clinical Sciences
Zip code
164-0001
Address
4-10-2 Nakano, Nakano-ku, Tokyo, Japan
TEL
03-6853-7500
kazuo.kawahara@bsci.com
Public contact
Name of contact person
| 1st name | Ayako |
| Middle name | |
| Last name | Oda |
Organization
Boston Scientific Japan K.K.
Division name
Clinical Sciences
Zip code
164-0001
Address
4-10-2 Nakano, Nakano-ku, Tokyo, Japan
TEL
03-6853-7500
Homepage URL
Ayako.Oda@bsci.com
Sponsor or person
Institute
Boston Scientific Japan K.K.
Institute
Department
Personal name
Funding Source
Organization
Boston Scientific Japan K.K.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Not applicable
Address
Not applicable
Tel
Not applicable
Not applicable
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 | 10 | Month | 18 | 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
55
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
| 2018 | Year | 05 | Month | 18 | Day |
Date of IRB
| 2018 | Year | 05 | Month | 18 | Day |
Anticipated trial start date
| 2018 | Year | 11 | Month | 08 | Day |
Last follow-up date
| 2021 | Year | 01 | Month | 25 | 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 | 09 | Month | 27 | Day |
Last modified on
| 2021 | Year | 09 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043449
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
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