Prostate Immobilization Device Used During Radiation Treatments to Decrease Rectal Bleeding
- Conditions
- Prostate Cancer
- Registration Number
- NCT00114985
- Lead Sponsor
- Dana-Farber Cancer Institute
- Brief Summary
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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 100
- 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
- Inflammatory bowel disease (Crohns, or Ulcerative Colitis)
- Prostatic rectal fistula
- Stricture of anal canal
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Rectal toxicity at six month intervals 2 years
- Secondary Outcome Measures
Name Time Method Quality of Life 2 years sexual dysfunction at six month intervals 2 years urinary symptoms 2 years