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Prostate Immobilization Device Used During Radiation Treatments to Decrease Rectal Bleeding

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00114985
First Posted: June 21, 2005
Last Update Posted: July 28, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Brigham and Women's Hospital
Information provided by (Responsible Party):
Anthony V. D'Amico, MD, PhD, Dana-Farber Cancer Institute
June 20, 2005
June 21, 2005
July 28, 2017
April 2001
January 2005   (Final data collection date for primary outcome measure)
Rectal toxicity at six month intervals [ Time Frame: 2 years ]
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 ]
  • urinary symptoms [ Time Frame: 2 years ]
  • sexual dysfunction at six month intervals [ Time Frame: 2 years ]
  • 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
Intervention Model: Single Group Assignment
Masking: None (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
Sexes Eligible for Study: Male
31 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
 
NCT00114985
01-050
Yes
Not Provided
Not Provided
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
July 2017

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