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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
History of Changes

June 20, 2005
August 22, 2012
April 2001
January 2005   (final data collection date for primary outcome measure)
Rectal toxicity at six month intervals [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
Rectal toxicity at six month intervals
Complete list of historical versions of study NCT00114985 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Quality of Life
  • urinary symptoms
  • sexual dysfunction at six month intervals
Not Provided
Not Provided
 
Prostate Immobilization Device Used During Radiation Treatments to Decrease Rectal Bleeding
A Phase II Study of Late Rectal Toxicity Following 3-D Conformal External Beam Radiation Therapy Performed Using a Prostate Immobilization Device

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.
  • 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.
Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Prostate Cancer
Device: Prostate Immobilization Device
Device placed during radiation treatment
Not Provided
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
100
October 2008
January 2005   (final data collection date for primary outcome measure)

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
Male
31 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00114985
01-050
Yes
Anthony V. D'Amico, MD, PhD, Dana-Farber Cancer Institute
Dana-Farber Cancer Institute
Brigham and Women's Hospital
Principal Investigator: Anthony V. D'Amico, MD, PhD Dana-Farber Cancer Institute
Dana-Farber Cancer Institute
August 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP