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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SpaceOAR Hydrogel | Device | The SpaceOAR System is an in-situ formed absorbable hydrogel that is administered transperineally (with transrectal ultrasound guidance) between the prostate and rectum |
| 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. | Post injection gel surgery 1-10 days |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Nianzeng Xing, Doctor | Hospital Executive | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanxi Cancer Hospital | Taiyuan | Shanxi | 030013 | China |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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.
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| ID | Title | Description |
|---|---|---|
| BG000 | Single Arm Obsevational Study Total 14 Cases | 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. |
| 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 | 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. | 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. | Posted | Mean | Standard Deviation | cc | Post injection gel surgery 1-10 days |
|
Through the entire study phase until 10 months after the completion of radiotherapy.
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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 | 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. 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 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| compression fracture of the lumbo2 vertebrae | Surgical and medical procedures | compression fracture | Non-systematic Assessment | No metastasis was assessed by the investigators, independent of hydrogel and radiation therapy. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Coronavirus 2019 (COVID-19) | Infections and infestations | Coronavirus 2019 (CO | Non-systematic Assessment | Coronavirus 2019 (COVID-19) |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Taimin.Yue | Boston Scientific | 18911590729 | Taimin.yue@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 | Jan 25, 2022 | Feb 17, 2025 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 16, 2024 | Feb 17, 2025 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| 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. | 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. | 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. | 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. | Through the entire study phase until 10 months after the completion of radiotherapy. |
| years |
|
| Sex/Gender, Customized | The study indication was prostate cancer, so all enrolled patients were male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | score on a scale | After the completion of radiotherapy, the month 3 Expanded Prostate Cancer Index Composite (EPIC)-26 score was compared to the baseline EPIC-26 score. |
|
|
|
| Secondary | 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. | 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 | Posted | Mean | Standard Deviation | score on a scale | 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. |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | mm | 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. |
|
|
|
| Secondary | the Distance Between the Prostate and Rectum | The presence of SpaceOAR hydrogel between prostate and rectum is evaluated by MRI via distance indirectly. | Posted | Mean | Standard Deviation | mm | 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. |
|
|
|
| Secondary | Adverse Event Related to SpaceOAR Hydrogel (Safety) | The relationship of AE /ADE/SAE/SADE/UADEs will be assessed by investigators. | Posted | Count of Participants | Participants | Through the entire study phase until 10 months after the completion of radiotherapy. |
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| 0 |
| 14 |
| 1 |
| 14 |
| 4 |
| 14 |
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| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
| Title | Measurements |
|---|---|
|
| Sexual |
|