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NCT Number: NCT05735652

An Observational Study of Radiotherapy After Injection of 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.

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Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Sex eligibility

Male

Study type

Observational

Primary location

Shanxi Cancer Hospital

Taiyuan, Shanxi, 030013, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Primary outcomes

  1. Change of Dose Rectum Volume Receiving Radiation Between Radiotherapy Plannings Pre and Post SpaceOAR Hydrogel Injection.

    Time frame: Post injection gel surgery 1-10 days

    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.

Secondary outcomes

  1. Urinary, Bowel and Sexual Function Assessment Score

    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.

    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.

  2. Quality of Life Was Measured by EQ-5D-5L Scale（the Five-level Version of the EuroQol 5-Dimension Scale)

    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.

    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.

  3. The Distance Between Prostate and Rectum

    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 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.

  4. the Distance Between the Prostate and Rectum

    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.

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

  5. Adverse Event Related to SpaceOAR Hydrogel (Safety)

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

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

Sponsors and collaborators

Lead sponsor

Boston Scientific Corporation

Industry

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Feb 21, 2023
Registry last updated
May 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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