Home › Trials › NCT04905069

Using SpaceOAR Vue to reduce side effects in prostate cancer patients receiving targeted radiation therapy

Effectiveness of the SpaceOAR Vue System in Subjects With Prostate Cancer Being Treated With Stereotactic Body Radiotherapy

Not applicable Interventional Boston Scientific Corporation · NCT04905069

This study tests whether using the SpaceOAR Vue System can help prostate cancer patients have fewer side effects from targeted radiation therapy.

Quick facts

PhaseNot applicable
Study typeInterventional
Enrollment500 (estimated)
Ages18 Years and up
SexMale
SponsorBoston Scientific Corporation Industry-sponsored
Locations30 sites (Fort Myers, Florida and 29 other locations)
Trial IDNCT04905069 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the effectiveness of the SpaceOAR Vue System in minimizing late gastrointestinal toxicity in patients with prostate cancer undergoing Stereotactic Body Radiotherapy (SBRT). The study aims to demonstrate how this innovative spacer can improve patient outcomes by reducing side effects associated with radiation treatment. Participants must have confirmed invasive adenocarcinoma of the prostate and meet specific risk criteria to be eligible for the trial. The intervention involves the placement of the SpaceOAR Vue System prior to radiation therapy.

Who should consider this trial

Good fit: Ideal candidates are adult males aged 18 and older with intermediate risk prostate cancer planning to undergo SBRT.

Not a fit: Patients with prostate volumes greater than 80 cc or those not meeting the specified risk criteria may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly reduce gastrointestinal side effects for prostate cancer patients undergoing radiation therapy.

How similar studies have performed: Other studies have shown promising results with similar spacer technologies in reducing side effects from radiation therapy, indicating a potential for success in this approach.

Eligibility criteria

Show full inclusion / exclusion criteria 
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 contraindicated, a digital rectal exam may be performed to confirm the absence of gross posterior ECE)
* Subjects who had metastatic disease, other ongoing cancers which were treated during the study or subjects for whom pelvic lymph node radiotherapy was planned.
* Subjects with any prior invasive malignancy (except non-melanomatous skin cancer) unless the subject had been disease free for a minimum of 3 years.
* History of prostatectomy, transurethral prostate surgery (e.g. TUNA, TUMT, TURP) if performed within 1 year prior to screening, other local prostate cancer therapy (e.g., cryotherapy or brachytherapy) or previous pelvic irradiation at any time prior to screening.
* History of prior pelvic surgery requiring low anterior or abdominoperineal resections or rectal surgery.
* History of or active inflammatory bowel disease (IBD) such as Crohn's disease or ulcerative colitis.
* History of or current perirectal disease that may interfere with interpretation of study outcomes including anal or perianal diseases such as fistula.
* Bleeding hemorrhoids requiring medical intervention within the prior three months.
* Diagnosed active bleeding disorder or a clinically significant coagulopathy. Note: Patients on anticoagulants may be included if the anticoagulant medication can be discontinued for index procedure.
* Active inflammatory or infectious process involving the perineum, gastrointestinal (GI) or urinary tract based on positive diagnosis or suspected diagnosis in the presence of fever \>38⁰ C, WBC \> 12,000/uL.
* Compromised immune system or prior diagnoses for human immunodeficiency virus (HIV) (with a detectable viral load within the last 6 months)/acquired immunodeficiency syndrome (AIDS) or autoimmune disease.
* If a subject was enrolled in another investigational drug or device trial that had not completed the primary endpoint or that clinically interfered with this study.
* Unable to comply with the study requirements or follow-up schedule.
* Any condition the Investigator believed would interfere with the intent of the study or would make participation not in the best interest of the patient.
* Known iodine sensitivity or allergy
* Known polyethylene glycol (PEG) sensitivity or allergy

Where this trial is running

Fort Myers, Florida and 29 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Prostate CancerProstateCancerStereotactic Body RadiotherapySBRTSpacerSpaceOARSpaceOAR Vue
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.