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Could a tiny implant shield the rectum from radiation damage?

NCT ID NCT05354427

Disease control Sponsor: BioProtect 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
Running, but no longer taking on new participants.
Completed This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 26, 2026

Summary

This study looked at a small implantable spacer placed between the prostate and rectum in men receiving radiation for prostate cancer. The goal was to see if the spacer reduces the radiation dose reaching the rectum, potentially lowering side effects. A total of 175 men who already had the spacer and radiation took part. Researchers measured changes in rectal radiation dose before and after spacer placement.

What this could mean

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

Active substance
implantable spacer (a gel-like device placed between the prostate and rectum)
What this could lead to
If effective, this spacer could become a standard tool to reduce rectal side effects from radiation, making treatment safer and more tolerable.
What could go wrong
This is a completed observational study, not a randomized trial, so it cannot prove the spacer works better than no spacer. Individual results may vary.

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

175 people

The number who actually took part.

Started

Jun 2020

Finished

Jan 2022

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.

Who is studied

Prostate Cancer

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: \- Males at least 18 years of age, who have undergone radiation therapy with implantable spacers Exclusion Criteria: * Patients whose clinical and pathological data are not available. * Patients have been histologically diagnosed with invasive adenocarcinoma that is extracapsular with posterior extension

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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

Contacts and locations

Locations

  • Cuf Porto institution

    Porto, Portugal

  • Institute of Maria Skłodowska, Curie (MCMCC)

    Warsaw, Poland

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