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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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 Diseases, Male
Genital Neoplasms, Male
Neoplasms
Neoplasms by Site
Prostatic Diseases
Urogenital Neoplasms

ClinicalTrials.gov processed this record on November 27, 2014