Prostate Immobilization Device Used During Radiation Treatments to Decrease Rectal Bleeding

This study has been completed.
Sponsor:
Collaborator:
Brigham and Women's Hospital
Information provided by (Responsible Party):
Anthony V. D'Amico, MD, PhD, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier:
NCT00114985
First received: June 20, 2005
Last updated: August 22, 2012
Last verified: August 2012
  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.


Condition Intervention Phase
Prostate Cancer
Device: Prostate Immobilization Device
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Dana-Farber Cancer Institute:

Primary Outcome Measures:
  • Rectal toxicity at six month intervals [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Quality of Life [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • urinary symptoms [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • sexual dysfunction at six month intervals [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Enrollment: 100
Study Start Date: April 2001
Study Completion Date: October 2008
Primary Completion Date: January 2005 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: Prostate Immobilization Device
    Device placed during radiation treatment
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
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
  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
Principal Investigator: Anthony V. D'Amico, MD, PhD Dana-Farber Cancer Institute
  More Information

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
Study First Received: June 20, 2005
Last Updated: August 22, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by 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

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases

ClinicalTrials.gov processed this record on April 17, 2014