Localized T1-T2 Prostate CancerNCT05407714

SpaceOAR System RWS in China

A study testing SpaceOAR Treatment in people with Localized T1-T2 Prostate Cancer, run by Boston Scientific Corporation at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This study aims to evaluate the safety and performance of SpaceOAR System when it is used to create space between the rectum and prostate in men undergoing radiotherapy for localized T1-T2 prostate cancer in China via collecting the real word data of SpaceOAR System used, to generate local clinical evidence on Chinese… Read more about this study

Who is it for?: Any age
Conditions the study is for: Localized T1-T2 Prostate Cancer
What is being tested?: SpaceOAR Treatment
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 15 participants
Where: 1 siteChina
Study dates: 18 Aug 2022to 6 Jul 2023
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages Any age
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

Subjects has provided the written informed consent, willing to participate in clinical data collection and willing to receive visit at 30 days post procedure. (for subjects enrolled prospectively)
Subjects must have been pathologically confirmed prostate cancer with clinical stage T1-T2, and have been treated or will be treated with Space OAR Hydrogel in hospital in Hainan Boao Lecheng medical pilot zone.
Exclusion Criteria- no specific exclusion criteria unless the patients refuse to sign the informed consent.

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

China1 site

Boao First Life Care Center-Hospital
Qionghai, Hainan, 571434

Other trials in China

About this study

Official title: A Real Word Study to Evaluate the Safety and Performance of SpaceOAR System When Used to Create Space Between the Rectum and Prostate in Men Undergoing Radiotherapy for Localized T1-T2 Prostate Cancer in China

Read the detailed description

This study is a retrospective and prospective, single arm, real world study. For those patients who have already received the SpaceOAR treatment before study kick-off, the data at baseline and the day of procedure will be retrospectively collected. For those patients who will receive SpaceOAR treatment after study kick-off, the clinical data at baseline, the day of procedure and 30 days post procedure will be prospectively collected.

Up to 20 subjects with a pathologically confirmed diagnosis of clinical stage T1 or T2 prostate cancer indicated for radiotherapy will be enrolled, for there are chances of missing data in the real world study. A sample of 14 subjects provides at least 90% power for the primary objective.

Conditions: Localized T1-T2 Prostate Cancer
Being tested: SpaceOAR Treatment

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

SpaceOAR TreatmentDevice
SpaceOAR System is intended to temporarily position the anterior rectal wall away from the prostate during radiotherapy for prostate cancer and in creating this space it is the intent of SpaceOAR System to reduce the radiation dose delivered to the anterior rectum.
The SpaceOAR System is composed of biodegradable material and maintains space for the entire course of prostate radiotherapy treatment and is completely absorbed by the patient's body over time.

Study groups in NCT05407714
Study group	Role	What they receive
SpaceOAR Treatment Arm	Experimental	Single arm, up to 20 subjects with a pathologically confirmed diagnosis of clinical stage T1 or T2 prostate cancer indicated for radiotherapy will be enrolled, for there are chances of missing data in the real world study. A sample of 14 subjects provides at least 90% power for the primary objective. Receives: Device: SpaceOAR Treatment

What is being measured

The primary outcome is the main question the study is designed to answer.

Primary Effectiveness Endpoint
The distance between the posterior prostatic capsule and anterior rectal wall,
Measured: Within 10 days post spaceOAR hydrogel administration.
Primary Safety Endpoint
Subjects with AEs related to SpaceOAR system and/or procedure within 30 days following procedure will be observed.
Measured: Within 30 days following procedure

Secondary outcomes (1)

Functional Success
Distance Posterior Prostatic Capsule and Anterior Rectal Wall
Measured: Within 10 days post spaceOAR hydrogel administration.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

18 Aug 20226 Jul 2023

First posted7 Jun 2022
Study start18 Aug 2022
Primary completion12 Jun 2023
Study completion6 Jul 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Localized T1-T2 Prostate CancerStudies of the same condition, open and under way.
More trials run by Boston Scientific CorporationThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 15 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05407714
Sponsor's protocol ID: U0720
Status last verified: Oct 2025
First submitted: 27 May 2022
Last updated: 27 Oct 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: Undecided

Study at a glance

From the registry record, last updated by the sponsor on 27 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Real Word Study to Evaluate the Safety and Performance of SpaceOAR System When Used to Create Space Between the Rectum and Prostate in Men Undergoing Radiotherapy for Localized T1-T2 Prostate Cancer in China
ClinicalTrials.gov ID: NCT05407714
Acronym / sponsor ID: U0720
Conditions: Localized T1-T2 Prostate Cancer
Study type: Interventional
Recruitment status: Completed
Enrolment: 15 participants (actual)
Lead sponsor: Boston Scientific CorporationIndustry (pharma, biotech, devices)
Study start: 18 Aug 2022 (actual)
Primary completion: 12 Jun 2023 (actual)
Study completion: 6 Jul 2023 (actual)
First posted: 7 Jun 2022 (actual)
Results: Posted 22 Feb 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
SpaceOAR Treatment Arm	Experimental	Device: SpaceOAR TreatmentSingle arm, up to 20 subjects with a pathologically confirmed diagnosis of clinical stage T1 or T2 prostate cancer indicated for radiotherapy will be enrolled, for there are chances of missing data in the real world study. A sample of 14 subjects provides at least 90% power for the primary objective.

Who may qualify

Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (3 listed)

Subjects has provided the written informed consent, willing to participate in clinical data collection and willing to receive visit at 30 days post procedure. (for subjects enrolled prospectively)
Subjects must have been pathologically confirmed prostate cancer with clinical stage T1-T2, and have been treated or will be treated with Space OAR Hydrogel in hospital in Hainan Boao Lecheng medical pilot zone.
Exclusion Criteria- no specific exclusion criteria unless the patients refuse to sign the informed consent.

Key exclusion criteria (0 listed)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
SpaceOAR TreatmentSpaceOAR System is intended to temporarily position the anterior rectal wall away from the prostate during radiotherapy for prostate cancer and in creating this space it is the intent of SpaceOAR System to reduce the radiation dose delivered to the anterior rectum. The SpaceOAR System is composed of biodegradable material and maintains space for the entire course of prostate radiotherapy treatment and is completely absorbed by the patient's body over time.	Device	SpaceOAR Treatment Arm

Primary outcome

Primary Effectiveness Endpoint
Time frame: Within 10 days post spaceOAR hydrogel administration.
The distance between the posterior prostatic capsule and anterior rectal wall,
Primary Safety Endpoint
Time frame: Within 30 days following procedure
Subjects with AEs related to SpaceOAR system and/or procedure within 30 days following procedure will be observed.

1 secondary outcome

Functional Success
Time frame: Within 10 days post spaceOAR hydrogel administration.

Results and safety

Results posted to the registry on 22 Feb 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
SpaceOAR Treatment Arm	15	15

Primary outcome: Primary Effectiveness Endpoint

Time frame: Within 10 days post spaceOAR hydrogel administration.. Mean (Standard Deviation). Unit: mm

Measure	SpaceOAR Treatment Arm n = 14
Value	15.1 (1.8)

Population analysed: The distance between the posterior prostatic capsule and anterior rectal wall is measured on the axial image slice closest to halfway between apex and base, from posterior edge of prostate to inner rectal wall via MRI.

Primary outcome: Primary Safety Endpoint

Time frame: Within 30 days following procedure. Count of participants. Unit: Participants

Measure	SpaceOAR Treatment Arm n = 15
Value	2

1 secondary outcome is reported in the full results.

Adverse events

Time frame: 30 days post procedure.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
SpaceOAR Treatment Arm	0 of 15 (0%)	4 of 15 (26.7%)	0 of 15

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Undecided

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Sujun Han principal investigator

Boao Yiling Life Care Center

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing SpaceOAR Treatment in people with Localized T1-T2 Prostate Cancer, run by Boston Scientific Corporation at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 22 Feb 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Primary Effectiveness Endpoint (time frame: Within 10 days post spaceOAR hydrogel administration.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05407714.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2025.