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Gel shield could spare prostate cancer patients from radiation damage

NCT ID NCT06451614

Disease control 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Sep 15, 2026 · Updated 8 times

Summary

This study tests a gel called SpaceIT that is placed between the prostate and rectum before radiation therapy for prostate cancer. The gel acts as a spacer to reduce radiation reaching the rectum, potentially lowering side effects. About 230 adults with low- to intermediate-risk prostate cancer will receive the gel and then undergo standard external beam radiation. The goal is to see if the gel safely reduces rectal radiation exposure.

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

About 230 people

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

Started

Oct 2024

Expected to finish

Mar 2028

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: Subjects must meet the following criteria to be eligible for participation in the study: 1. Age ≥18 years old 2. Subjects must have had pathologically confirmed (by routine hematoxylin and eosin \[H\&E\] staining) invasive adenocarcinoma of the prostate and planning to undergo EBRT 3. Subjects must meet ALL of the following: 1. Clinical stage T1-T2c (AJCC Ver. 8) tumor AND 2. Gleason Score 7 or less as determined from a biopsy taken within 12 months of the Baseline visit AND 3. Demonstrated blood prostate specific antigen (PSA) levels ≤20 ng/ml as measured within 6 months of the Baseline visit and prior to commencing androgen deprivation therapy (ADT) 4. Subject is able to provide written informed consent, approved by the appropriate Institutional Review Board/Ethics Committee/Research Ethics Board (IRB/EC/REB) of the respective clinical site Exclusion Criteria: 1. Prostate \> 80 cc 2. Subjects who are planning to undergo brachytherapy or focal boost 3. Subjects who have magnetic resonance imaging (MRI) evidence of gross posterior extracapsular extension (ECE) of the prostate cancer Note: MRI must be taken within 6 months prior to the Baseline visit 4. Subjects who have metastatic disease, other ongoing cancers which are being treated during the study or subjects for whom pelvic lymph node radiotherapy is planned 5. Subjects with any prior invasive solid tumor malignancy or hematologic malignancy (except non-melanomatous skin cancer) unless the subject has been disease free and treatment free for a minimum of 3 years 6. History of radical prostatectomy, other ablative anti-prostate cancer therapy (e.g., cryotherapy, high intensity focused ultrasound, irreversible electroporation) or previous pelvic irradiation (including prior prostate brachytherapy) at any time prior to screening 7. History of transurethral prostate surgery (e.g., Transurethral Needle Ablation (TUNA), Transurethral Microwave Therapy (TUMT), Transurethral Resection of the Prostate (TURP)) if performed within 1 year prior to screening 8. History of prior pelvic surgery requiring low anterior or abdominoperineal resections or rectal surgery 9. History of or current perirectal disease that may interfere with interpretation of study outcomes, including anal or perianal diseases such as fistula 10. Bleeding hemorrhoids requiring medical intervention within the prior three months 11. Diagnosed active bleeding disorder or a clinically significant coagulopathy, defined as PTT \> 70s or aPTT\>35s or INR \> 1.4, or platelet count \< 100,000 per mm3 Note: Subjects on anticoagulants may be included if the anticoagulant medication can be held for index procedure 12. Active inflammatory or infectious process involving the perineum, GI or urinary tract based on positive diagnosis or suspected diagnosis in the presence of fever \>38⁰ C, WBC \> 12,000/uL 13. Inability to undergo pelvic MRI or presence of implants causing severe artifact (e.g. bilateral arthroplasty) that interferes with imaging interpretation for this study at Investigator discretion 14. 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 15. Unable to comply with the study requirements or follow-up schedule 16. 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 17. Known PEG (polyethylene glycol) sensitivity or allergy 18. Known iodine sensitivity or allergy 19. ADT, if applicable, cannot or was not started 15-60 days prior to the pre-index procedure RT planning imaging and is planned to continue for a total planned duration greater than 6 months

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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

  • Associated Urological Specialists

    Chicago Ridge, Illinois, 60415, United States

  • Baptist Hospital of Miami

    Miami, Florida, 33176, United States

  • Emory University Hospital

    Atlanta, Georgia, 30308, United States

  • Evergreen Hospital Medical Center

    Kirkland, Washington, 98034, United States

  • Gibbs Cancer Center and Research Institute

    Greer, South Carolina, 29650, United States

  • Houston Metro Urology

    Houston, Texas, 77027, United States

  • Integrated Medical Professionals

    New York, New York, 10016, United States

  • Memorial Sloan Kettering

    New York, New York, 10065, United States

  • Mercy Cancer Center Bon Secours Mercy Healt

    Elyria, Ohio, 44035, United States

  • MidLantic Urology

    Bala-Cynwyd, Pennsylvania, 19004, United States

  • Midtown Urology Associates

    Austin, Texas, 78705, United States

  • Orange County Urology Associates

    Laguna Hills, California, 92653, United States

  • Orlando Health Cancer Institute

    Orlando, Florida, 32806, United States

  • Perelman Center for Advanced Medicine

    Philadelphia, Pennsylvania, 19104, United States

  • Perlmutter Cancer Center - NYU Langone

    New York, New York, 10016, United States

  • Princess Margaret Cancer Centre

    Toronto, Ontario, M5G 2M9, Canada

  • Rio Grande Urology

    El Paso, Texas, 79912, United States

  • Ronald Reagan UCLA Medical Center

    Los Angeles, California, 90095, United States

  • Springfield Clinic, LLC

    Springfield, Illinois, 62701, United States

  • Sunnybrook Health Sciences Centre-Hospital

    Toronto, Ontario, M4N 3M5, Canada

  • The Ottawa Hospital - General Campus

    Ottawa, Ontario, K1H 8L6, Canada

  • University Hospitals of Cleveland-Hospital

    Cleveland, Ohio, 44106, United States

  • University of Kansas Hospital

    Kansas City, Kansas, 66160, United States

  • University of Texas, Southwestern Medical Center

    Dallas, Texas, 75390, United States

  • University of Washington Medical Center-Hospital

    Seattle, Washington, 98195, United States

  • UroPartners

    Glenview, Illinois, 60026, United States

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