An Observational Study of Radiotherapy After Injection of SpaceOAR Hydrogel

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

Study Overview

• Status: Active, not recruiting
• Conditions: Prostate Cancer
• Intervention / Treatment: Device: SpaceOAR Hydrogel

Detailed Description

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.

• Study Type: Observational
• Enrollment (Actual): 14

Contacts and Locations

Study Locations

• China
  • Shanxi
    • Taiyuan, Shanxi, China, 030013
      • Shanxi Cancer Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Device: 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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Boston Scientific Corporation
• Investigators: Principal Investigator: Nianzeng Xing, Doctor, Hospital Executive

Study record dates

Study Major Dates

• Study Start (Actual): November 3, 2022
• Primary Completion (Actual): April 30, 2024
• Study Completion (Estimated): December 30, 2024

Study Registration Dates

• First Submitted: August 22, 2022
• First Submitted That Met QC Criteria: February 9, 2023
• First Posted (Actual): February 21, 2023

Study Record Updates

• Last Update Posted (Actual): May 1, 2024
• Last Update Submitted That Met QC Criteria: April 30, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Urogenital Diseases; Male Urogenital Diseases; Genital Diseases, Male; Genital Diseases; Prostatic Neoplasms
• Other Study ID Numbers: U0745

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No