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Radiation Therapy
SpaceOAR Vue System for Prostate Cancer (SABRE Trial)
N/A
Recruiting
Led By Suneil Jain, MB, BCh, MRCP, FRCR, PhD
Research Sponsored by Boston Scientific Corporation
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Subjects must have pathologically confirmed invasive adenocarcinoma of the prostate and been planning to undergo SBRT
Subjects must have intermediate risk prostate cancer as defined by the presence of specific criteria
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 to 24 months post-sbrt initiation
Awards & highlights
SABRE Trial Summary
This trial shows that the SpaceOAR system is effective in reducing late GI toxicity in people undergoing SBRT to treat prostate cancer.
Who is the study for?
This trial is for men over 18 with invasive prostate cancer who plan to undergo SBRT. They must have a clinical stage T2b-T2c tumor, Gleason Score of 7, or PSA levels between 10-20 ng/ml. Exclusions include PSA >20 ng/ml, metastatic disease, prior malignancies (unless disease-free for 3 years), previous local prostate treatments or pelvic irradiation, compromised immune systems, large prostates (>80 cc), and certain medical conditions.Check my eligibility
What is being tested?
The SpaceOAR Vue System is being tested to see if it can reduce late gastrointestinal side effects in patients receiving Stereotactic Body Radiotherapy (SBRT) for prostate cancer. The study will involve subjects using the system during their SBRT treatment.See study design
What are the potential side effects?
While specific side effects of the SpaceOAR Vue System are not detailed here, similar interventions may cause discomfort at the application site, potential infection risk due to an implantable device and possible interference with radiation therapy leading to bowel issues.
SABRE Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with invasive prostate cancer and plan to undergo SBRT.
Select...
My prostate cancer is at an intermediate risk level.
Select...
I am 18 years old or older.
SABRE Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3 to 24 months post-sbrt initiation
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 to 24 months post-sbrt initiation
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Late Gastrointestinal (GI) Toxicity
Secondary outcome measures
EPIC-26 bowel score
SABRE Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: SpaceOAR VueExperimental Treatment1 Intervention
Subjects will receive radiotherapy following injection of the SpaceOAR Vue hydrogel.
Group II: No-Spacer ControlActive Control1 Intervention
Subjects will receive radiotherapy without the use of the SpaceOAR Vue.
Find a Location
Who is running the clinical trial?
Boston Scientific CorporationLead Sponsor
716 Previous Clinical Trials
934,005 Total Patients Enrolled
3 Trials studying Prostate Cancer
248 Patients Enrolled for Prostate Cancer
Suneil Jain, MB, BCh, MRCP, FRCR, PhDPrincipal InvestigatorQueen's University, Belfast
Suneil Jain, MB, BCh, PhDPrincipal InvestigatorQueen's University, Belfast
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Eligibility Criteria:
This trial includes the following eligibility criteria:- My prostate cancer biopsy shows a Gleason Score of 8 or higher.I have been diagnosed with invasive prostate cancer and plan to undergo SBRT.My prostate cancer is at an intermediate risk level.I, or my authorized representative, have signed the consent form after understanding the study.My PSA level was over 20 ng/ml before starting hormone therapy.My prostate was larger than 80 cc in the last 9 months.My cancer is at an advanced local stage.I am 18 years old or older.
Research Study Groups:
This trial has the following groups:- Group 1: No-Spacer Control
- Group 2: SpaceOAR Vue
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there still opportunities for participation in this research project?
"Data hosted on clinicaltrials.gov affirms that this medical experiment, initially posted in December of 2021, is currently recruiting patients. The study has also been updated as recently as November 17th 2022."
Answered by AI
What is the population size of participants in this investigation?
"To carry out the study, 500 patients who meet inclusion criteria must be enrolled. Boston Scientific Corporation is responsible for operating the trial through its multiple sites including Florida Urology Partners, LLC in Tampa and GenesisCare USA in Fort Myers."
Answered by AI
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