Prostate Immobilization Device Used During Radiation Treatments to Decrease Rectal Bleeding
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.
ClinicalTrials.gov Identifier: NCT00114985
Recruitment Status :
First Posted : June 21, 2005
Last Update Posted : July 28, 2017
Dana-Farber Cancer Institute
Brigham and Women's Hospital
Information provided by (Responsible Party):
Anthony V. D'Amico, MD, PhD, Dana-Farber Cancer Institute
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
Device: Prostate Immobilization Device
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.
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, Learn About Clinical Studies.
Ages Eligible for Study:
31 Years and older (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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
Inflammatory bowel disease (Crohns, or Ulcerative Colitis)