Rectal Spacers Use in Prostate Cancer Radiation Therapy

Last updated: September 10, 2024
Sponsor: Princeton ProCure management, LLC.
Overall Status: Active - Recruiting

Phase

N/A

Condition

Prostate Disorders

Prostate Cancer, Early, Recurrent

Prostate Cancer

Treatment

SpaceOAR Vue

BioProtect Balloon Implant System

Clinical Study ID

NCT06594887
1378387
  • Ages > 18
  • Male

Study 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.

Eligibility Criteria

Inclusion

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 Design

Total Participants: 50
Treatment Group(s): 2
Primary Treatment: SpaceOAR Vue
Phase:
Study Start date:
September 06, 2024
Estimated Completion Date:
December 31, 2025

Connect with a study center

  • Procure Proton Therapy Center

    Somerset, New Jersey 08873
    United States

    Active - Recruiting

Map preview placeholder

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.