Localized T1-T2 Prostate Cancer
Conditions
Brief summary
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.
Detailed 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.
Interventions
DEVICESpaceOAR Treatment
SpaceOAR System is intended to temporarily position the anterior rectal wall away from the prostate during radiotherapy for prostate cancer and in creating this space it is the intent of SpaceOAR System to reduce the radiation dose delivered to the anterior rectum. The SpaceOAR System is composed of biodegradable material and maintains space for the entire course of prostate radiotherapy treatment and is completely absorbed by the patient's body over time.
Sponsors
Boston Scientific Corporation
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary Effectiveness Endpoint | Within 10 days post spaceOAR hydrogel administration. | The distance between the posterior prostatic capsule and anterior rectal wall, |
| Primary Safety Endpoint | Within 30 days following procedure | Subjects with AEs related to SpaceOAR system and/or procedure within 30 days following procedure will be observed. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Functional Success | Within 10 days post spaceOAR hydrogel administration. | Distance Posterior Prostatic Capsule and Anterior Rectal Wall |
Countries
China
Participant flow
Recruitment details
Enrolled 15 subjects, and collected 14 cases valid data .
Participants by arm
| Arm | Count |
|---|---|
| SpaceOAR Treatment Arm 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.
SpaceOAR Treatment: SpaceOAR System is intended to temporarily position the anterior rectal wall away from the prostate during radiotherapy for prostate cancer and in creating this space it is the intent of SpaceOAR System to reduce the radiation dose delivered to the anterior rectum.
The SpaceOAR System is composed of biodegradable material and maintains space for the entire course of prostate radiotherapy treatment and is completely absorbed by the patient's body over time. | 15 |
| Total | 15 |
Baseline characteristics
| Characteristic | SpaceOAR Treatment Arm |
|---|---|
| Age, Continuous | 73.7 years STANDARD_DEVIATION 7.8 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 15 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 0 Participants |
| Region of Enrollment China | 15 participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 15 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 15 |
| other Total, other adverse events | 4 / 15 |
| serious Total, serious adverse events | 0 / 15 |
Outcome results
Primary
Primary Effectiveness Endpoint
The distance between the posterior prostatic capsule and anterior rectal wall,
Time frame: Within 10 days post spaceOAR hydrogel administration.
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SpaceOAR Treatment Arm | Primary Effectiveness Endpoint | 15.1 mm | Standard Deviation 1.8 |
Primary
Primary Safety Endpoint
Subjects with AEs related to SpaceOAR system and/or procedure within 30 days following procedure will be observed.
Time frame: Within 30 days following procedure
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| SpaceOAR Treatment Arm | Primary Safety Endpoint | 2 Participants |
Secondary
Functional Success
Distance Posterior Prostatic Capsule and Anterior Rectal Wall
Time frame: Within 10 days post spaceOAR hydrogel administration.
Population: Creation of at least 7.5mm space between the posterior prostatic capsule and anterior rectum wall via comparative pre and post SpaceOAR hydrogel injection MRI scans.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| SpaceOAR Treatment Arm | Functional Success | 14 Participants |