Rectal Spacers Use in Prostate Cancer Radiation Therapy

Clinicaltrials.gov ID: NCT06594887
db-list-check Status RECRUITING
b-loader Phase NA
b-people Age ≥ 18 Years
b-bullseye-arrow Enrollments 50

Conditions

Prostate Cancer

Summary

This prospective, 2-arm clinical trial aims to evaluate the use of rectal spacers in patients with localized prostate cancer scheduled for Proton Beam Therapy (PBT). Up to 50 subjects will be enrolled in this study.Study visits will include screening, spacer placement, treatment planning, end-of-treatment assessment, and follow-up visits at 1, 3, and 6 months.

Locations

1 location Found with status Recruiting

Status

  • RECRUITING

Contact Person

Eligibility Criteria

Inclusion Criteria

1. Subjects greater than 18 years old with prostate cancer
2. Subjects must have histologically confirmed adenocarcinoma of the prostate with biopsy taken within 12 months and must be planned to undergo proton beam therapy with rectal spacer
3. Subjects must have clinical stage T1-T3 with no posterior extra capsular extension of the prostate cancer
4. PSA less than or equal to 20 ng/mL
5. Gleason Score less than or equal to 7
6. Capacity to comprehend and readiness to sign a written informed consent form

Exclusion Criteria

1. Planned Pelvic lymph node radiotherapy.
2. Metastatic disease.
3. Prior local prostate cancer therapy
4. Active Inflammatory bowel disease requiring treatment with steroids.
5. Prior radical prostatectomy.
6. Active urinary tract infection.
7. Acute or chronic inflammation or infection of the prostate.

Study Plan

SpaceOAR Vue

  • DEVICE:

    SpaceOAR Vue

    Description:

    Peri-rectal hydrogel spacer consists of a layer of polyethylene-glycol gel (SpaceOAR vue) in order to outdistance the prostate from anterior rectal wall

BioProtect Balloon Implant System

  • DEVICE:

    BioProtect Balloon Implant System

    Description:

    The balloon spacer is a biodegradable balloon made of poly (L-Lactide-co-caprolactone) which is a co-polymer of Poly Lactide acid and epsilon Caprolactone (BioProtect Balloon Implant System, BioProtect Ltd) inflated with saline, providing around 18 mm space height , and can be deflated and repositioned if needed, both laterally and along the distal /proximal planes, for optimal uniformity of spacing.

Outcome Measures

Primary Outcome Measures

Perirectal distance

Time Frame: 2-4 months

Secondary Outcome Measures

Spacer stability over time

Time Frame: 2-4 months

Mean rectal dose

Time Frame: 2-4 months

Timeline

  • Last Updated
    September 19, 2024
  • Start Date
    September 19, 2024
  • Today
    February 5, 2025
  • Completion Date ( Estimated )
    December 1, 2025

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