An Observational Study of Radiotherapy After Injection of SpaceOAR Hydrogel

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Prostate Cancer

Intervention / Treatment
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* Device: SpaceOAR Hydrogel


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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.
Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Subjects with localized T1-T2 prostate cancer in China who were injected with SpaceOAR Hydrogel<br>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. | Device: SpaceOAR Hydrogel<br>* The SpaceOAR System is an in-situ formed absorbable hydrogel that is administered transperineally (with transrectal ultrasound guidance) between the prostate and rectum<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Baseline, post injection gel surgery 1-10 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Urinary,bowel and Sexual fountion assessment | Descrpition of change of urinary,bowel and Sexual fountion 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 to a 0-100 scale , with higher scores representing better HRQOL. | 2 weeks, 6 weeks , 3 months | 
| Quality of life was measured by EQ-5D-5L 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 minimum value and maximum value of EQ VAS (EQ visual analogue scale) are 0 ，100 respectively, which a higher value means a beter outcome. | 2 weeks, 6 weeks , 3 months | 
| The distance between prostate and rectum was 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. | 6 weeks | 
| The unabsorption rate of SpaceOAR hydrogel was measured by MRI | The absorption of SpaceOAR hydrogel between prostate and rectum is evaluated by MRI. | 10 months | 
| Adverse event related to SpaceOAR hydrogel (Safety) | The relationship of AE /ADE/SAE/SADE/UADEs will be assessed by investigators. | 2 weeks, 6 week , 3 months,10 months |