A Phase II Study of Late Rectal Toxicity Following 3-D Conformal External Beam Radiation Therapy Performed Using a Prostate Immobilization Device
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Prostate Cancer
- Sponsor
- Dana-Farber Cancer Institute
- Enrollment
- 100
- Primary Endpoint
- Rectal toxicity at six month intervals
- Status
- Completed
- Last Updated
- 3 years ago
Overview
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.
Investigators
Anthony V. D'Amico, MD, PhD
Principal Investigator
Dana-Farber Cancer Institute
Eligibility 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
Outcomes
Primary Outcomes
Rectal toxicity at six month intervals
Time Frame: 2 years
Secondary Outcomes
- urinary symptoms(2 years)
- Quality of Life(2 years)
- sexual dysfunction at six month intervals(2 years)