Active — Not RecruitingNot Applicable

Effectiveness of the SpaceOAR Vue System in Subjects With Prostate Cancer

United States, Australia, France500 participantsStarted 2021-12-21

Plain-language summary

To demonstrate the effectiveness of the SpaceOAR Vue System in reducing late gastrointestinal (GI) toxicity in subjects undergoing Stereotactic Body Radiotherapy (SBRT) to treat prostate cancer.

Who can participate

Age range

18 Years

Sex

MALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Age ≥ 18 years old. * Subjects must have pathologically confirmed (by routine hematoxylin and eosin (H\&E) staining) invasive adenocarcinoma of the prostate and been planning to undergo SBRT. * Subjects must have intermediate risk prostate cancer as defined by the presence of one or more of the following: * Clinical Stage T2b - T2c (AJCC 6th edition) tumor * Gleason Score 7 as determined from a biopsy taken within 9 months preceding Enrollment (randomization) * Demonstrated blood PSA levels 10-20 ng/ml as measured within 6 months preceding Enrollment (randomization) and prior to commencing androgen deprivation therapy (ADT) * Subject or authorized representative was informed of the nature of the study and provided written informed consent, approved by the appropriate Institutional Review Board (IRB)/Ethics Committee (EC) of the respective clinical site. Exclusion Criteria: * Prostate \>80 cc documented within 9 months preceding Enrollment (randomization) * Clinical stage T3 or T4 (AJCC 6th edition) tumor * Blood PSA level \>20 ng/ml as measured within 6 months preceding Enrollment (randomization) and prior to commencing androgen deprivation therapy (ADT) * Gleason Score ≥ 8 as determined from a biopsy taken within 9 months preceding Enrollment (randomization) * Subjects who had MRI evidence of gross posterior extracapsular extension (ECE) of the prostate cancer. (Note: MRI should be from within 9 months preceding Enrollment (randomization). If MRI is …

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Late Gastrointestinal (GI) Toxicity

Timeframe: 3 to 24 months post-SBRT initiation

Trial details

NCT IDNCT04905069

SponsorBoston Scientific Corporation

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2027-04

View on ClinicalTrials.gov More Prostate Cancer trials