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

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 - SpaceOAR system PMS

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000038131

Enrollment

Registered

2019-10-18

Start date

2018-11-08

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostate cancer

Interventions

SpaceOAR system

Eligibility

Sex/Gender

Male

Inclusion criteria

Inclusion criteria: Men undergoing LDR Brachytherapy monotherapy for localized Prostate Cancer in accordance with the IFU and Appropriate Use Document.

Exclusion criteria

Exclusion criteria: NA

Design outcomes

Primary

Measure	Time frame
- Mean mid gland (axial) perirectal space following SpaceOAR hydrogel implantation (mm). - Change in prostate dimensions before and after SpaceOAR placement.	—

Secondary

Measure	Time frame
- 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	—

Measure

Time frame

- 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

—

Countries

Japan

Contacts

Public ContactAyako Oda

Boston Scientific Japan K.K. Clinical Sciences

Ayako.Oda@bsci.com03-6853-7500

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026