An Observational Study of Radiotherapy After Injection of SpaceOAR Hydrogel

An observational study of 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.

Trial summary

This observational study aims to evaluate the safety and effectiveness of radiotherapy for subjects with localized T1-T2 prostate cancer in China who were injected with SpaceOAR Hydrogel, via collecting clinical data related to radiotherapy. Read more about this study

Who is it for?: Any age, men only
Conditions the study is for: Prostate Cancer
What is being tested?: SpaceOAR Hydrogel
Type of treatment: Medical device
How many people: 14 participants
Where: 1 siteChina
Study dates: 3 Nov 2022to 21 Aug 2024
How long will I take part?: 10 Months
Phase: Observational
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
Men only
No healthy volunteers
Child, Adult, Older adult

Study population: During screening, patients who have received or will receive radiotherapy will be identified. These who have been injected with SpaceOAR hydrogel will be enrolled. For patients who have already received radiotherapy, the clinical data can be collected retrospectively, and informed consent will be performed (If follow up visits can be conducted prospectively). For patients who will receive radiotherapy, informed consent will be gained.

Who may be able to join

Subjects have provided the written informed consent, are willing to participate in clinical data collection and willing to comply with study procedure. (for subjects enrolled prospectively)
Subjects must have been pathologically confirmed prostate cancer with clinical stage T1-T2, and have been treated with Space OAR Hydrogel, and have received or will receive radiotherapy.

Who cannot join

All subjects have received radiotherapy or will receive radiotherapy, who have injected with SpaceOAR hydrogel in Boao Medical Pilot Zone.
There is no specific exclusion criteria unless the patients refuse to sign the informed consent.

Trial locations and contacts

1 site in 1 country.

China1 site

Shanxi Cancer Hospital
Taiyuan, Shanxi, 030013

Other trials in China

About this study

Official title: An Observational Study to Evaluate the Safety and Effectiveness of Radiotherapy for Localized T1-T2 Prostate Cancer in China After Injection of SpaceOAR Hydrogel

Read the detailed description

This study protocol is for the second part of SpaceOAR real world study in which long term follow-up visits will be performed (up to 1 year) outside Boao Medical Tourism Pilot Zone. The SpaceOAR real world study is a retrospective and prospective, single arm, observational study (Ptotocol of SpaceOAR RWS Windchill#: 92743236). Subjects with localized T1-T2 prostate cancer who have already been injected with the SpaceOAR and have received radiotherapy or will receive radiotherapy will be enrolled, and clinical data related to radiotherapy will be collected. For subjects who have already completed radiotherapy before study kick-off, clinical data will be collected retrospectively, such as data related to radiotherapy, AE (if any) and MRI (if any). Follow up vist will be completed if applicable. For subjects who receive therapy after study kick-off, follow up visits at 2 weeks, 6weeks, 3 months and 10 months after radiotherapy will be scheduled to assess bowel, urinary and sexual function and quality of life.

Conditions: Prostate Cancer
Being tested: SpaceOAR Hydrogel
Medical subject headings: Prostatic Neoplasms

What participants receive

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

SpaceOAR HydrogelDevice
The SpaceOAR System is an in-situ formed absorbable hydrogel that is administered transperineally (with transrectal ultrasound guidance) between the prostate and rectum

Study groups in NCT05735652
Study group	Role	What they receive
Subjects with localized T1-T2 prostate cancer in China who were injected with SpaceOAR Hydrogel		This observational study aims to evaluate the safety and effectiveness of radiotherapy for subjects with localized T1-T2 prostate cancer in China who were injected with SpaceOAR Hydrogel, via collecting clinical data related to radiotherapy. Receives: Device: SpaceOAR Hydrogel

What is being measured

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

Change of Dose Rectum Volume Receiving Radiation Between Radiotherapy Plannings Pre and Post SpaceOAR Hydrogel Injection.
Change of dose rectum volume receiving radiation,which is measured by Dose-volume histogram in radiotherapy planning pre and post SpaceOAR hydrogel injection radiotherpy planning is made based on CT simulation scans.
Measured: Post injection gel surgery 1-10 days

Secondary outcomes (5)

Urinary, Bowel and Sexual Function Assessment Score
Descrpition of change of urinary, bowel and Sexual function assessment score, which are measured by Expanded Prostate cancer Index Composite (EPIC)-26. EPIC-26 is short form version to measure health related quality of life among men with prostate cancer, which contains 26 item and 5 domains : Urinary Incontinence, Urinary irritative/Obstructive, Bowel, Sexual, and Hormonal. Response options for each EPIC item form a Likert scale, and multi-item scale scores are transformed linearly from 0 score to 100 scores, with higher scores representing better.
Measured: After the completion of radiotherapy, the month 3 Expanded Prostate Cancer Index Composite (EPIC)-26 score was compared to the baseline EPIC-26 score.
Quality of Life Was Measured by EQ-5D-5L Scale（the Five-level Version of the EuroQol 5-Dimension Scale)
Frequencies and proportions of responses in five dimension (Mobility, Anxiety/Depression, Pain/Discomfort, Usual Activities and Self-Care) and different levels will be tabulated, which was measured by EQ-5D-5L scale（the five-level version of the EuroQol 5-Dimension scale).The minimum value and maximum value of EQ VAS (EQ visual analogue scale) are from 0 score to100 scores, which a higher value means a beter outcome.
Measured: After the completion of radiotherapy, the month 3 EQ-5D-5L scale（the five-level version of the EuroQol 5-Dimension scale) score was compared to the baseline EQ-5D-5L scale score.
The Distance Between Prostate and Rectum
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.
Measured: After the completion of radiotherapy, the weeks 6 the distance between prostate and rectum measured by MRI was compared to the baseline the distance between prostate and rectum measured by MRI.
the Distance Between the Prostate and Rectum
The presence of SpaceOAR hydrogel between prostate and rectum is evaluated by MRI via distance indirectly.
Measured: After the completion of radiotherapy, the month 10 the distance between prostate and rectum measured by MRI was compared to the baseline the distance between prostate and rectum measured by MRI.
Adverse Event Related to SpaceOAR Hydrogel (Safety)
The relationship of AE /ADE/SAE/SADE/UADEs will be assessed by investigators.
Measured: Through the entire study phase until 10 months after the completion of radiotherapy.

Timeline

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

3 Nov 202221 Aug 2024

First posted21 Feb 2023
Study start3 Nov 2022
Primary completion30 Apr 2024
Study completion21 Aug 2024

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 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: Observational
Observational model: Cohort
Time perspective: Other
Enrolment: 14 participants (actual)
Target duration: 10 Months

IDs, dates and publications

ClinicalTrials.gov ID: NCT05735652
Sponsor's protocol ID: U0745
Status last verified: May 2025
First submitted: 22 Aug 2022
Last updated: 30 May 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Prostate Cancer trials

Study at a glance

From the registry record, last updated by the sponsor on 30 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Observational Study to Evaluate the Safety and Effectiveness of Radiotherapy for Localized T1-T2 Prostate Cancer in China After Injection of SpaceOAR Hydrogel
ClinicalTrials.gov ID: NCT05735652
Acronym / sponsor ID: U0745
Conditions: Prostate Cancer
Study type: Observational
Recruitment status: Completed
Enrolment: 14 participants (actual)
Lead sponsor: Boston Scientific CorporationIndustry (pharma, biotech, devices)
Study start: 3 Nov 2022 (actual)
Primary completion: 30 Apr 2024 (actual)
Study completion: 21 Aug 2024 (actual)
First posted: 21 Feb 2023 (actual)
Results: Posted 26 Mar 2025

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

Observational model: Cohort
Time perspective: Other
Target follow-up: 10 Months
Number of arms: 1

Arm	Type	Receives
Subjects with localized T1-T2 prostate cancer in China who were injected with SpaceOAR Hydrogel	–	Device: SpaceOAR HydrogelThis observational study aims to evaluate the safety and effectiveness of radiotherapy for subjects with localized T1-T2 prostate cancer in China who were injected with SpaceOAR Hydrogel, via collecting clinical data related to radiotherapy.

Who may qualify

Sex: Male only
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult
Study population: During screening, patients who have received or will receive radiotherapy will be identified. These who have been injected with SpaceOAR hydrogel will be enrolled. For patients who have already received radiotherapy, the clinical data can be collected retrospectively, and informed consent will be performed (If follow up visits can be conducted prospectively). For patients who will receive radiotherapy, informed consent will be gained.

Key inclusion criteria (2 listed)

Subjects have provided the written informed consent, are willing to participate in clinical data collection and willing to comply with study procedure. (for subjects enrolled prospectively)
Subjects must have been pathologically confirmed prostate cancer with clinical stage T1-T2, and have been treated with Space OAR Hydrogel, and have received or will receive radiotherapy.

Key exclusion criteria (2 listed)

All subjects have received radiotherapy or will receive radiotherapy, who have injected with SpaceOAR hydrogel in Boao Medical Pilot Zone.
There is no specific exclusion criteria unless the patients refuse to sign the informed consent.

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 HydrogelThe SpaceOAR System is an in-situ formed absorbable hydrogel that is administered transperineally (with transrectal ultrasound guidance) between the prostate and rectum	Device	Subjects with localized T1-T2 prostate cancer in China who were injected with SpaceOAR Hydrogel

Primary outcome

Change of Dose Rectum Volume Receiving Radiation Between Radiotherapy Plannings Pre and Post SpaceOAR Hydrogel Injection.
Time frame: Post injection gel surgery 1-10 days
Change of dose rectum volume receiving radiation,which is measured by Dose-volume histogram in radiotherapy planning pre and post SpaceOAR hydrogel injection radiotherpy planning is made based on CT simulation scans.

5 secondary outcomes

Urinary, Bowel and Sexual Function Assessment Score
Time frame: After the completion of radiotherapy, the month 3 Expanded Prostate Cancer Index Composite (EPIC)-26 score was compared to the baseline EPIC-26 score.
Quality of Life Was Measured by EQ-5D-5L Scale（the Five-level Version of the EuroQol 5-Dimension Scale)
Time frame: After the completion of radiotherapy, the month 3 EQ-5D-5L scale（the five-level version of the EuroQol 5-Dimension scale) score was compared to the baseline EQ-5D-5L scale score.
The Distance Between Prostate and Rectum
Time frame: After the completion of radiotherapy, the weeks 6 the distance between prostate and rectum measured by MRI was compared to the baseline the distance between prostate and rectum measured by MRI.
the Distance Between the Prostate and Rectum
Time frame: After the completion of radiotherapy, the month 10 the distance between prostate and rectum measured by MRI was compared to the baseline the distance between prostate and rectum measured by MRI.
Adverse Event Related to SpaceOAR Hydrogel (Safety)
Time frame: Through the entire study phase until 10 months after the completion of radiotherapy.

Results and safety

Results posted to the registry on 26 Mar 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Observational Study of 14 Cases, Single Arm	14	14

Primary outcome: Change of Dose Rectum Volume Receiving Radiation Between Radiotherapy Plannings Pre and Post SpaceOAR Hydrogel Injection.

Time frame: Post injection gel surgery 1-10 days. Mean (Standard Deviation). Unit: cc

Measure	Subjects With Localized T1-T2 Prostate Cancer in China Who Were Injected With SpaceOAR Hydrogel n = 14
Rectum wall V37Gy (cc)	2.4 (2.8)
Rectum wall V46Gy (cc)	2.7 (2.5)

Population analysed: Potential subjects for this study are patients with localized prostate cancer enrolled in the SpaceOAR Hainan Real World Study (U0720) who have been treated with SpaceOAR hydrogel at a hospital in the Boao Licheng Medical Pilot Area in Hainan and have received or will receive radiation therapy at the study center.

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: Through the entire study phase until 10 months after the completion of radiotherapy.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Subjects With Localized T1-T2 Prostate Cancer in China Who Were Injected With SpaceOAR Hydrogel	1 of 14 (7.1%)	4 of 14 (28.6%)	0 of 14

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Prostate Cancer

Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
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Active, not recruitingObservational study
MRI Fusion Biopsy vs. Micro-Ultrasound Guided Biopsy
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Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer
Recruiting
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Prostate Cancer, Urinary Incontinence

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.

Nianzeng Xing, Doctor principal investigator

Hospital Executive

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

Questions about this trial

What is this clinical trial studying?

An observational study of 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 2 inclusion and 2 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 30 May 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 26 Mar 2025). 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?

Change of Dose Rectum Volume Receiving Radiation Between Radiotherapy Plannings Pre and Post SpaceOAR Hydrogel Injection. (time frame: Post injection gel surgery 1-10 days). 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 NCT05735652.

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 30 May 2025.