SpaceOAR System RWS in China

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Localized T1-T2 Prostate Cancer

Intervention / Treatment
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* Device: SpaceOAR Treatment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SpaceOAR Treatment Arm<br>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. | Device: SpaceOAR Treatment<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary Effectiveness Endpoint | The distance between the posterior prostatic capsule and anterior rectal wall post SpaceOAR hydrogel administration. Measurement: 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. | Within 10 days post spaceOAR hydrogel administration. | 
| Primary Safety Endpoint | AEs related to SpaceOAR system and/or procedure within 30 days following procedure will be observed. | Within 30 days following procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Functional Success | Defined as creation of at least 7.5mm space between the posterior prostatic capsule and anterior rectum wall as assessed via comparative pre and post SpaceOAR hydrogel injection MRI scans. | Within 10 days post spaceOAR hydrogel administration. |