Rectal Spacers in Prostate Cancer Patients Undergoing Radiation Therapy

Clinicaltrials.gov ID: NCT06599476
db-list-check Status RECRUITING
b-loader Phase NA
b-people Age ≥ 18 Years
b-bullseye-arrow Enrollments 150

Conditions

Prostate Cancer

Summary

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,and 6-months FU visits.

Locations

1 location Found with status Recruiting

Status

  • RECRUITING

Contact Person

Eligibility Criteria

Inclusion Criteria:

1. Patients with prostate cancer ≥ 18 years of age.
2. Patients are in one of the following risk groups:

* T1-T3 prostate cancer with no posterior extra capsular extension
* Gleason score ≤ 7
3. Planned for radiation treatment with rectal spacer.
4. Ability to understand and the willingness to sign a written informed consent form.

Exclusion Criteria:

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

Study Plan

BioProtect Balloon Implant System

EXPERIMENTAL

The Bio Protect Balloon Implant System (BioProtectLtd.,TzurYigal,Israel) is an Food and Drug Administration approved rectal spacer that consists of a solid biodegradable balloon-shaped material composed of poly L-Lactide-co-caprolactone

  • DEVICE:

    BioProtect Balloon Implantu2122 System

    Description:

    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

Outcome Measures

Primary Outcome Measures

Dosimetry

Time Frame: 6 months

Timeline

  • Last Updated
    September 19, 2024
  • Start Date
    September 19, 2024
  • Today
    January 16, 2025
  • Completion Date ( Estimated )
    December 1, 2025

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