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Prostate Immobilization Device Used During Radiation Treatments to Decrease Rectal Bleeding

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ClinicalTrials.gov Identifier: NCT00114985
Recruitment Status : Completed
First Posted : June 21, 2005
Last Update Posted : July 28, 2017
Sponsor:
Collaborator:
Brigham and Women's Hospital
Information provided by (Responsible Party):
Anthony V. D'Amico, MD, PhD, Dana-Farber Cancer Institute

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Prostate Cancer Device: Prostate Immobilization Device Phase 2

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Study of Late Rectal Toxicity Following 3-D Conformal External Beam Radiation Therapy Performed Using a Prostate Immobilization Device
Study Start Date : April 2001
Actual Primary Completion Date : January 2005
Actual Study Completion Date : October 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources


Intervention Details:
    Device: Prostate Immobilization Device
    Device placed during radiation treatment


Primary Outcome Measures :
  1. Rectal toxicity at six month intervals [ Time Frame: 2 years ]

Secondary Outcome Measures :
  1. Quality of Life [ Time Frame: 2 years ]
  2. urinary symptoms [ Time Frame: 2 years ]
  3. sexual dysfunction at six month intervals [ Time Frame: 2 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   31 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Biopsy proven prostate cancer
  • Clinical Stage T1 - T4
  • Negative bone scan
  • PSA and routine blood work
  • >30 years of age
  • ECOG Performance 0,1, or 2
  • No prior pelvic radiation
  • No pacemaker

Exclusion Criteria:

  • Inflammatory bowel disease (Crohns, or Ulcerative Colitis)
  • Prostatic rectal fistula
  • Stricture of anal canal

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00114985


Sponsors and Collaborators
Dana-Farber Cancer Institute
Brigham and Women's Hospital
Investigators
Principal Investigator: Anthony V. D'Amico, MD, PhD Dana-Farber Cancer Institute

Publications:
Responsible Party: Anthony V. D'Amico, MD, PhD, Principal Investigator, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier: NCT00114985     History of Changes
Other Study ID Numbers: 01-050
First Posted: June 21, 2005    Key Record Dates
Last Update Posted: July 28, 2017
Last Verified: July 2017

Keywords provided by Anthony V. D'Amico, MD, PhD, Dana-Farber Cancer Institute:
Total Androgen Suppression
Simulation
3-D Conformal External Beam Radiation Therapy
Intra-rectal immobilization device
Quality of Life Assessment Questionnaire
Rectal Bleeding
Late effects