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NCT Number: NCT06599476

Rectal Spacers in Prostate Cancer Patients Undergoing Radiation Therapy

This is a prospective clinical study involving up to 150 subjects with localized prostate cancer who are scheduled for radiation treatment with rectal spacer placement.

The goal of this clinical trial is to assess the safety and efficacy of perirectal spacers in patients undergoing radiation therapy for the treatment of localized prostate cancer.

Study visits:

* Screening * Spacer placement * Treatment planning simulation * End of the radiation treatment * 1, 3, 6, 12, 18 and 24-months FU visits.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Advanced Radiation Centers of New York

New Hyde Park, New York, 11042, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with prostate cancer ≥ 18 years of age.
  • Patients are in one of the following risk groups:
  • T1-T3 prostate cancer with no posterior extra capsular extension
  • Gleason score ≤ 7
  • Planned for radiation treatment with rectal spacer.
  • Ability to understand and the willingness to sign a written informed consent form.

Exclusion criteria

  • Metastatic disease.
  • Previously treated localized adenocarcinoma of the prostate.
  • Active Inflammatory bowel disease requiring treatment with steroids.
  • Prior total prostatectomy.
  • Current urinary tract infection.
  • Acute or chronic prostatitis.

Treatment and study plan

BioProtect Balloon Implant™ System

Device

The BioProtect Balloon Implant System is intended to temporarily position the anterior rectal wall away from the prostate during radiotherapy for prostate cancer, and by creating this space, to reduce the radiation dose delivered to the anterior rectum. The balloon is inserted into the perirectal space and inflated to its pre-defined size. The Balloon is made of biodegradable materials that maintain the space for the entire course of prostate radiation treatment and are absorbed by the patient's body over time

Primary outcomes

  1. Dosimetry

    Time frame: 6 months

    Dose-volume histogram (DVH) including the percent of the rectal volume receiving 70 Gy

Sponsors and collaborators

Lead sponsor

Advanced Radiation Centers of New York

Other

Registry information

Official study title

Use of Rectal Spacers in Prostate Cancer Patients Undergoing Radiation Therapy: a Prospective Clinical Study

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Sep 19, 2024
Registry last updated
Jun 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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