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New gel shields bowel during prostate radiation – could cut side effects

NCT ID NCT04905069

Symptom relief Sponsor: Boston Scientific Corporation Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Sep 15, 2026 · Updated 7 times

Summary

This trial tests a biodegradable gel called SpaceOAR Vue that is injected between the prostate and rectum before radiation therapy. The gel temporarily pushes the rectum away to reduce radiation damage. About 500 men with intermediate-risk prostate cancer will be randomly assigned to get the gel or not. The main goal is to see if the gel lowers bowel side effects like diarrhea or bleeding in the two years after treatment.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
SpaceOAR Vue System (a biodegradable gel injected to create space between the prostate and rectum)
What this could lead to
If it works, this gel could reduce bowel problems after prostate radiation, making treatment easier to tolerate.
What could go wrong
This is a mid-stage study with 500 people, so results may not apply to everyone. The gel itself carries risks like infection or discomfort, and it only addresses side effects, not the cancer itself.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

500 people

The number who actually took part.

Started

Dec 2021

Expected to finish

Dec 2030

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Male participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

neoplasm prostate cancer prostate carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Prostate cancer

Contacts and locations

Locations

  • Azienda Ospedaliero Universitaria di Parma

    Parma, 43126, Italy

  • Belfast City Hospital

    Belfast, BT9 7AB, United Kingdom

  • Bon Secours Radiotherapy Cork

    Cork, T12 DV56, Ireland

  • Bristol Haematology and Oncology Centre

    Bristol, BS2 8ED, United Kingdom

  • Calvary Mater Newcastle

    Waratah, New South Wales, 2298, Australia

  • Derriford General Hospital

    Plymouth, PL6 8DH, United Kingdom

  • Dr. John Sylvester

    Myrtle Beach, South Carolina, 29572, United States

  • Florida Urology Partners, LLC

    Tampa, Florida, 33609, United States

  • GenesisCare USA

    Fort Myers, Florida, 33908, United States

  • GenesisCare USA

    Troy, Michigan, 48098, United States

  • GenesisCare, Hospital San Francisco de Asis

    Madrid, 28002, Spain

  • Hospital Universitario Cruces

    Barakaldo, 48903, Spain

  • Hospital Universitario Ramón y Cajal

    Madrid, Spain

  • IRCCS Ospedale Sacro Cuore Don Calabria

    Verona, 37024, Italy

  • Inselspital - University Hospital Bern

    Bern, 3010, Switzerland

  • Institut Gustave Roussy

    Villejuif, Cedex, 94805, France

  • Institut de Radiothérapie & Radiochirurgie HARTMANN

    Levallois-Perret, 92300, France

  • Kansas University Medical Center

    Kansas City, Kansas, 66160, United States

  • Klinikum Nurnberg Nord

    Nuremberg, 90419, Germany

  • MEDICLIN Robert Janker Klinik

    Bonn, D-53129, Germany

  • New Jersey Urology, a Summit Health Company

    Bloomfield, New Jersey, 07003, United States

  • Norfolk and Norwich University Hospital NHS Trust

    Norwich, NR4 7UY, United Kingdom

  • Policlinico Universitario Agostino Gemelli

    Rome, Italy

  • Princess Alexandra Hospital - ROPAIR

    Woolloongabba, Queensland, 4102, Australia

  • Royal Marsden Hospital

    London, SW3 6JJ, United Kingdom

  • Royal Surrey County Hospital NHS Foundation Trust

    Guildford, Surrey, GU27XX, United Kingdom

  • Sir Charles Gairdner Hospital

    Nedlands, Western Australia, 6009, Australia

  • University Hospital Basel

    Basel, CH-4031, Switzerland

  • University of Pittsburgh Medical Center

    Pittsburgh, Pennsylvania, 15232, United States

  • Velindre Cancer Centre

    Cardiff, Wales, CF14 2TL, United Kingdom

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