SpaceOAR System RWS in China

Boston Scientific

Status: Completed

Conditions: Localized T1-T2 Prostate Cancer

Treatments: Device: SpaceOAR Treatment

Study type: Interventional

Funder types: Industry

Identifiers

NCT05407714

U0720

Details and patient eligibility

About

This study aims to evaluate the safety and performance of SpaceOAR System when it is used to create space between the rectum and prostate in men undergoing radiotherapy for localized T1-T2 prostate cancer in China via collecting the real word data of SpaceOAR System used, to generate local clinical evidence on Chinese patients.

Full description

This study is a retrospective and prospective, single arm, real world study. For those patients who have already received the SpaceOAR treatment before study kick-off, the data at baseline and the day of procedure will be retrospectively collected. For those patients who will receive SpaceOAR treatment after study kick-off, the clinical data at baseline, the day of procedure and 30 days post procedure will be prospectively collected.

Up to 20 subjects with a pathologically confirmed diagnosis of clinical stage T1 or T2 prostate cancer indicated for radiotherapy will be enrolled, for there are chances of missing data in the real world study. A sample of 14 subjects provides at least 90% power for the primary objective.

Enrollment: 15 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• Subjects has provided the written informed consent, willing to participate in clinical data collection and willing to receive visit at 30 days post procedure. (for subjects enrolled prospectively)
• Subjects must have been pathologically confirmed prostate cancer with clinical stage T1-T2, and have been treated or will be treated with Space OAR Hydrogel in hospital in Hainan Boao Lecheng medical pilot zone.

Exclusion Criteria- no specific exclusion criteria unless the patients refuse to sign the informed consent.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

15 participants in 1 patient group

SpaceOAR Treatment Arm

Experimental group

Description:

Single arm, up to 20 subjects with a pathologically confirmed diagnosis of clinical stage T1 or T2 prostate cancer indicated for radiotherapy will be enrolled, for there are chances of missing data in the real world study. A sample of 14 subjects provides at least 90% power for the primary objective.

Treatment:

Device: SpaceOAR Treatment