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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
Must not have
Gleason Score ≥ 8 as determined from a biopsy taken within 9 months preceding Enrollment (randomization)
Blood PSA level >20 ng/ml as measured within 6 months preceding Enrollment (randomization) and prior to commencing androgen deprivation therapy (ADT)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 to 24 months post-sbrt initiation
Awards & highlights
No Placebo-Only Group

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.
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.
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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been diagnosed with invasive prostate cancer and plan to undergo SBRT.
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My prostate cancer is at an intermediate risk level.
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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
My prostate cancer biopsy shows a Gleason Score of 8 or higher.
Select...
My PSA level was over 20 ng/ml before starting hormone therapy.
Select...
My cancer is at an advanced local stage.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 to 24 months post-sbrt initiation
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 to 24 months post-sbrt initiation for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Late Gastrointestinal (GI) Toxicity
Secondary study objectives
EPIC-26 bowel score

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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
743 Previous Clinical Trials
856,942 Total Patients Enrolled
4 Trials studying Prostate Cancer
478 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

Media Library

Stereotactic Body Radiotherapy (Radiation Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT04905069 — N/A
Prostate Cancer Research Study Groups: No-Spacer Control, SpaceOAR Vue
Prostate Cancer Clinical Trial 2023: Stereotactic Body Radiotherapy Highlights & Side Effects. Trial Name: NCT04905069 — N/A
Stereotactic Body Radiotherapy (Radiation Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04905069 — N/A
~222 spots leftby Apr 2027
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