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Prostate Immobilization Device Used During Radiation Treatments to Decrease Rectal Bleeding


filter terms:

  • Purpose

    During 3D-conformal external beam radiation therapy treatments for prostate cancer, the prostate gland moves.
    The purpose of this study is to determine whether the placement of a prostate immobilization device into the rectum during radiation treatments will decrease the risk of rectal bleeding that is sometimes seen as a late effect from radiation.


    status: active, not recruiting
    conditions: Prostate Cancer
    interventions: Prostate Immobilization Device
    phase: Phase 2
    study type: Interventional
    study design: Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study
    official title: A Phase II Study of Late Rectal Toxicity Following 3-D Conformal External Beam Radiation Therapy Performed Using a Prostate Immobilization Device

  • Further study details (as provided by Dana-Farber Cancer Institute)

    primary outcome measures:

    • Rectal toxicity at six month intervals [ Time Frame: 2 years ]

    secondary outcome measures:

    • Quality of Life [ Time Frame: 2 years ]
    • urinary symptoms [ Time Frame: 2 years ]
    • sexual dysfunction at six month intervals [ Time Frame: 2 years ]

    enrollment: 25

    study start date: April 2001

    study completion date: January 2009


    Detailed description

    • MRI using an endorectal coil done prior to treatment for staging.
      • Baseline Quality of Life (QOL) assessment will be completed prior to treatment.
      • Total androgen suppression is initiated and will continue for at least 6 months.
      • Prostate Immobilization Device (PID) placed during the planning session.
      • PID will be placed daily for the first 15 3D external beam radiation treatments.
      • QOL assessment and follow-up will take place every 6 months for 3 years.

      • Eligibility

        ages eligible for study: 31 Years and older
        genders eligible for study: Male

        Criteria

        Inclusion Criteria:

        Exclusion Criteria:

      • Contacts and locations

        Please refer to this study by its ClinicalTrials.gov identifier: NCT00114985

      • Sponsors and collaborators

        Dana-Farber Cancer Institute
        Brigham and Women's Hospital

        investigators: Anthony V. D'Amico, MD, PhD, Principal Investigator, Dana-Farber Cancer Institute

      • More information

        Other publications

        Woel R, Beard C, Chen MH, Hurwitz M, Loffredo M, McMahon E, Ching J, Lopes L, D'Amico AV. Acute gastrointestinal, genitourinary, and dermatological toxicity during dose-escalated 3D-conformal radiation therapy (3DCRT) using an intrarectal balloon for prostate gland localization and immobilization. Int J Radiat Oncol Biol Phys. 2005 Jun 1;62(2):392-6.

        first received: June 20, 2005
        last updated: December 20, 2007
        ClinicalTrials.gov Identifier: NCT00114985
        health authority: United States: Institutional Review Board

      Information obtained from ClinicalTrials.gov on September 25, 2009   Link to the current ClinicalTrials.gov record.

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