Trial Outcomes & Findings for An Observational Study of Radiotherapy After Injection of SpaceOAR Hydrogel (NCT NCT05735652)

Results Overview

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.

Recruitment status

COMPLETED

Target enrollment

14 participants

Primary outcome timeframe

Post injection gel surgery 1-10 days

Results posted on

2025-05-30

Participant Flow

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 Lecheng Medical Pilot Area in Hainan and have received or will receive radiation therapy at the study center.

Participant milestones

Participant milestones
Measure	Observational Study of 14 Cases, Single Arm This observational study single arm aims to evaluate the safety and effectiveness of radiotherapy for subjects with localized T1-T2 prostate cancer in China who were injected with SpaceOARHydrogel, via collecting clinical data related to radiotherapy.
Overall Study STARTED	14
Overall Study COMPLETED	14
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

An Observational Study of Radiotherapy After Injection of SpaceOAR Hydrogel

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Single Arm Obsevational Study Total 14 Cases n=14 Participants This observational single arm 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. SpaceOAR Hydrogel: The SpaceOAR System is an in-situ formed absorbable hydrogel that is administered transperineally (with transrectal ultrasound guidance) between the prostate and rectum.
Age, Continuous	74.1 years STANDARD_DEVIATION 7.9 • n=5 Participants
Sex/Gender, Customized Count of Participants · Male	14 Participants n=5 Participants
Sex/Gender, Customized Count of Participants · Female	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	14 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: Post injection gel surgery 1-10 days

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Subjects With Localized T1-T2 Prostate Cancer in China Who Were Injected With SpaceOAR Hydrogel n=14 Participants 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. SpaceOAR Hydrogel: The SpaceOAR System is an in-situ formed absorbable hydrogel that is administered transperineally (with transrectal ultrasound guidance) between the prostate and rectum
Change of Dose Rectum Volume Receiving Radiation Between Radiotherapy Plannings Pre and Post SpaceOAR Hydrogel Injection. Rectum wall V37Gy (cc)	2.4 cc Standard Deviation 2.8
Change of Dose Rectum Volume Receiving Radiation Between Radiotherapy Plannings Pre and Post SpaceOAR Hydrogel Injection. Rectum wall V46Gy (cc)	2.7 cc Standard Deviation 2.5

SECONDARY outcome

Timeframe: After the completion of radiotherapy, the month 3 Expanded Prostate Cancer Index Composite (EPIC)-26 score was compared to the baseline EPIC-26 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.

Outcome measures

Outcome measures
Measure	Subjects With Localized T1-T2 Prostate Cancer in China Who Were Injected With SpaceOAR Hydrogel n=14 Participants 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. SpaceOAR Hydrogel: The SpaceOAR System is an in-situ formed absorbable hydrogel that is administered transperineally (with transrectal ultrasound guidance) between the prostate and rectum
Urinary, Bowel and Sexual Function Assessment Score Bowel function	99.4 score on a scale Standard Deviation 1.5
Urinary, Bowel and Sexual Function Assessment Score Urinary Incontinence	92.9 score on a scale Standard Deviation 12.7
Urinary, Bowel and Sexual Function Assessment Score Urinary rritative /Obstructive	96.0 score on a scale Standard Deviation 5.3
Urinary, Bowel and Sexual Function Assessment Score Sexual	31 score on a scale Standard Deviation 16.1

SECONDARY outcome

Timeframe: 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.

Population: 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), and follow up will be performed, if applicable. For subjects who receive therapy after study kick-off, radiotherapy relevant clinical data will be collected, and follow up visits after radiotherapy will be scheduled to assess urinary, bowel, sexual functions and AE

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.

Outcome measures

Outcome measures
Measure	Subjects With Localized T1-T2 Prostate Cancer in China Who Were Injected With SpaceOAR Hydrogel n=14 Participants 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. SpaceOAR Hydrogel: The SpaceOAR System is an in-situ formed absorbable hydrogel that is administered transperineally (with transrectal ultrasound guidance) between the prostate and rectum
Quality of Life Was Measured by EQ-5D-5L Scale（the Five-level Version of the EuroQol 5-Dimension Scale)	1.0 score on a scale Standard Deviation 0.0

SECONDARY outcome

Timeframe: 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 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.

Outcome measures

Outcome measures
Measure	Subjects With Localized T1-T2 Prostate Cancer in China Who Were Injected With SpaceOAR Hydrogel n=14 Participants 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. SpaceOAR Hydrogel: The SpaceOAR System is an in-situ formed absorbable hydrogel that is administered transperineally (with transrectal ultrasound guidance) between the prostate and rectum
The Distance Between Prostate and Rectum	5.4 mm Standard Deviation 3.8

SECONDARY outcome

Timeframe: 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.

The presence of SpaceOAR hydrogel between prostate and rectum is evaluated by MRI via distance indirectly.

Outcome measures

Outcome measures
Measure	Subjects With Localized T1-T2 Prostate Cancer in China Who Were Injected With SpaceOAR Hydrogel n=14 Participants 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. SpaceOAR Hydrogel: The SpaceOAR System is an in-situ formed absorbable hydrogel that is administered transperineally (with transrectal ultrasound guidance) between the prostate and rectum
the Distance Between the Prostate and Rectum	2.0 mm Standard Deviation 1.2

SECONDARY outcome

Timeframe: Through the entire study phase until 10 months after the completion of radiotherapy.

The relationship of AE /ADE/SAE/SADE/UADEs will be assessed by investigators.

Outcome measures

Outcome measures
Measure	Subjects With Localized T1-T2 Prostate Cancer in China Who Were Injected With SpaceOAR Hydrogel n=14 Participants 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. SpaceOAR Hydrogel: The SpaceOAR System is an in-situ formed absorbable hydrogel that is administered transperineally (with transrectal ultrasound guidance) between the prostate and rectum
Adverse Event Related to SpaceOAR Hydrogel (Safety)	0 Participants

Adverse Events

Subjects With Localized T1-T2 Prostate Cancer in China Who Were Injected With SpaceOAR Hydrogel

Serious events: 1 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Subjects With Localized T1-T2 Prostate Cancer in China Who Were Injected With SpaceOAR Hydrogel n=14 participants at risk 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. SpaceOAR Hydrogel: The SpaceOAR System is an in-situ formed absorbable hydrogel that is administered transperineally (with transrectal ultrasound guidance) between the prostate and rectum
Surgical and medical procedures compression fracture of the lumbo2 vertebrae	7.1% 1/14 • Number of events 1 • Through the entire study phase until 10 months after the completion of radiotherapy.

Other adverse events

Other adverse events
Measure	Subjects With Localized T1-T2 Prostate Cancer in China Who Were Injected With SpaceOAR Hydrogel n=14 participants at risk 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. SpaceOAR Hydrogel: The SpaceOAR System is an in-situ formed absorbable hydrogel that is administered transperineally (with transrectal ultrasound guidance) between the prostate and rectum
Infections and infestations Coronavirus 2019 (COVID-19)	28.6% 4/14 • Number of events 4 • Through the entire study phase until 10 months after the completion of radiotherapy.

Additional Information

Taimin.Yue

Boston Scientific

Phone: 18911590729

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place