SpaceOAR Vue System for Prostate Cancer

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Royal Surrey County Hospital NHS Foundation Trust, Guildford, United KingdomProstate CancerSpaceOAR Vue System - Device
Eligibility
18+
Male
What conditions do you have?
Select

Study Summary

This trial shows that the SpaceOAR system is effective in reducing late GI toxicity in people undergoing SBRT to treat prostate cancer.

Eligible Conditions
  • Prostate Cancer

Treatment Effectiveness

Effectiveness Progress

1 of 3

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Stereotactic Body Radiation Therapy (SBRT)
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Study Objectives

1 Primary · 1 Secondary · Reporting Duration: 3 to 24 months post-SBRT initiation

24 months post-SBRT initiation
EPIC-26 bowel score
Month 24
Late Gastrointestinal (GI) Toxicity

Trial Safety

Safety Progress

1 of 3

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Stereotactic body radiation therapy
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Stereotactic Body Radiation Therapy (SBRT)
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Trial Design

2 Treatment Groups

No-Spacer Control
1 of 2
SpaceOAR Vue
1 of 2

Active Control

Experimental Treatment

500 Total Participants · 2 Treatment Groups

Primary Treatment: SpaceOAR Vue System · No Placebo Group · N/A

SpaceOAR Vue
Device
Experimental Group · 1 Intervention: SpaceOAR Vue System · Intervention Types: Device
No-Spacer ControlNoIntervention Group · 1 Intervention: No-Spacer Control · Intervention Types:

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 3 to 24 months post-sbrt initiation

Who is running the clinical trial?

Boston Scientific CorporationLead Sponsor
679 Previous Clinical Trials
919,738 Total Patients Enrolled
3 Trials studying Prostate Cancer
254 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

Eligibility Criteria

Age 18+ · Male Participants · 3 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have prostate cancer that is at a specific stage, with a certain Gleason score and blood PSA levels. You also need to have given written consent to participate in the study and have approval from the appropriate ethics committee.
References

Frequently Asked Questions

How many medical facilities are conducting this trial?

"Across the United States, 8 medical centres are offering this treatment. Examples include Florida Urology Partners in Tampa, GenesisCare USA in Fort Myers, and Kansas University Medical Center in Troy." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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