UMIN-CTR Clinical Trial

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

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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000043449