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

NCT ID NCT04905069

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

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.

Disclaimer Read more

This is a summary of the original study . Summaries may miss details or leave out important information. Before applying or accepting participation, make sure you have read and understood the full study. Curemydisease.com takes no responsibility whatsoever for anything missed, misunderstood, or acted upon as a result of our summary — we know it does not capture everything.

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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.

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