An Observational Study of Radiotherapy After Injection of SpaceOAR Hydrogel

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.

Time frame: 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.

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

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

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.

Time frame: 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

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.

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

Time frame: 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.

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.

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