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New study tracks safety of prostate cancer spacer gel for years after treatment

NCT ID NCT07300631

Knowledge-focused Sponsor: Sheffield Teaching Hospitals NHS Foundation Trust Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jul 31, 2026 · Updated 2 times

Summary

This study follows 320 men with prostate cancer who receive a hydrogel spacer (SpaceOAR) before radiotherapy. The spacer is placed between the prostate and rectum to protect healthy tissue. Researchers will collect data from medical records and patient questionnaires over three years to track side effects and long-term safety. The goal is to provide real-world evidence on how well the spacer works and its risks.

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.

Participants

About 320 people

The number the study aims to enrol. It can still change while the study runs.

Started

Dec 2025

Expected to finish

Feb 2030

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

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

Who is studied

Men with prostate cancer having radiotherapy with curative intent and having a SpaceOAR as part of standard care.

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: * All patients with a clinical diagnosis of prostate cancer planned to undergo treatment with curative intent at selected sites in the UK \& France subject to a SpaceOAR being used as usual care. * Aged 18 years old or above. * Patients who agrees to participate and has been deemed by their medical team to have capacity to provide; * verbal, informed consent over telephone as documented on the study informed consent form by the Researchers (UK only) * written, informed consent by signature of the study informed consent form (France only) * Patient covered by social security scheme (France only) Exclusion Criteria: \- Patients lacking the capacity to provide; * informed consent as documented on the study informed consent form by the - Researchers (UK only) * written, informed consent by signature of the study informed consent form (France only)

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Conditions

The condition(s) this trial relates to.

prostate cancer

As listed by the trial registrant

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

Prostate cancer patients treated by radiotherapy

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    8 sites in 2 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • CHU de Brest, Boulevard de Tanguy Prigent

    RECRUITING

    Brest, 29200, France

  • Centre de cancérologie Les Dentellières

    RECRUITING

    Valenciennes, 59300, France

  • Clinique Pasteur

    RECRUITING

    Toulouse, 31300, France

  • Maidstone & Tunbridge Wells NHS Trust

    RECRUITING

    Maidstone, ME16 9QQ, United Kingdom

  • Norfolk & Norwich University Hospital NHS Foundation Trust

    RECRUITING

    Norwich, NR 7UY, United Kingdom

  • Royal Free London

    RECRUITING

    London, NW3 2QG, United Kingdom

  • The Clatterbridge Cancer Centre NHS Foundation Trust

    RECRUITING

    Liverpool, L7 8YA, United Kingdom

  • University Hospitals of Derby & Burton NHS Foundation Trust

    RECRUITING

    Derby, Derbyshire, DE22 3NE, United Kingdom

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