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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 patients.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SpaceOAR Treatment | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Primary Effectiveness Endpoint | The distance between the posterior prostatic capsule and anterior rectal wall, | 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. | Within 30 days following procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Functional Success | Distance Posterior Prostatic Capsule and Anterior Rectal Wall | Within 10 days post spaceOAR hydrogel administration. |
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Inclusion Criteria:
Exclusion Criteria- no specific exclusion criteria unless the patients refuse to sign the informed consent.
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| Name | Affiliation | Role |
|---|---|---|
| Sujun Han | Boao Yiling Life Care Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Boao First Life Care Center-Hospital | Qionghai | Hainan | 571434 | China |
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Enrolled 15 subjects, and collected 14 cases valid data .
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| ID | Title | Description |
|---|---|---|
| FG000 | SpaceOAR Treatment Arm | 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. SpaceOAR Treatment: 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | SpaceOAR Treatment Arm | 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. SpaceOAR Treatment: 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Primary Effectiveness Endpoint | The distance between the posterior prostatic capsule and anterior rectal wall, | 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. | Posted | Mean | Standard Deviation | mm | Within 10 days post spaceOAR hydrogel administration. |
|
30 days post procedure.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | SpaceOAR Treatment Arm | 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. SpaceOAR Treatment: 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Urinary hesitation | Renal and urinary disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Associate Clinical Trial Manager | BSC International Medical Trading (Shanghai) Co., Ltd | +13671646036 | junyang.bai@bsci.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Oct 12, 2021 | Jan 12, 2024 | Prot_004.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 18, 2023 | Jan 12, 2024 | SAP_005.pdf |
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|
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Primary | Primary Safety Endpoint | Subjects with AEs related to SpaceOAR system and/or procedure within 30 days following procedure will be observed. | Posted | Count of Participants | Participants | Within 30 days following procedure |
|
|
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| Secondary | Functional Success | Distance Posterior Prostatic Capsule and Anterior Rectal Wall | Creation of at least 7.5mm space between the posterior prostatic capsule and anterior rectum wall via comparative pre and post SpaceOAR hydrogel injection MRI scans. | Posted | Count of Participants | Participants | Within 10 days post spaceOAR hydrogel administration. |
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| 0 |
| 15 |
| 0 |
| 15 |
| 4 |
| 15 |
| Urinary retention | Renal and urinary disorders | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | Systematic Assessment |
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| Influenza | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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