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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000038131
Receipt No. 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 2020/06/22

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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
Email 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
Email Ayako.Oda@bsci.com

Sponsor
Institute Boston Scientific Japan K.K.
Institute
Department

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
Email 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 初回届出年月日: 2018年5月18日; 届出回数: 第4回

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 No longer recruiting
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 02 Month 28 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
2020 Year 06 Month 22 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043449

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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